Quintiles Jobshttp://quintiles.jobs2012-05-21 08:27:41.763742USAClevelandTitle: Patient Ambassador - Cleveland, OH 4532 Location: USA-Ohio-Cleveland Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Patient Ambassadors to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Patient Ambassador The Patient Ambassador will provide focused home-based patient education regarding treatment of Psoriasis. They will also provide specialized education and training to home health care agencies, physicians, nursing and office staff within a defined geographic region and conduct training presentations to Psoriasis support groups regarding treatment of the disease. There will be occasional travel overnight for meeting attendance. This is a full time, field-based position. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements and Skills: * RN required * Four-year degree preferred * Current license in good standing * Dermatology / Biologic injectable experience helpful * Home health care experience helpful * Excellent presentations skills * Valid driver's license * Ability to manage multiple tasks2012-05-19 04:50:39United StatesQuintilesOhio1207470OHCleveland, OH28814275http://quintiles.jobs/xml/28814275/jobUSADallasTitle: Patient Ambassador - Dallas, TX 4532 Location: USA-Texas-Dallas Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Patient Ambassadors to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Patient Ambassador The Patient Ambassador will provide focused home-based patient education regarding treatment of Psoriasis. They will also provide specialized education and training to home health care agencies, physicians, nursing and office staff within a defined geographic region and conduct training presentations to Psoriasis support groups regarding treatment of the disease. There will be occasional travel overnight for meeting attendance. This is a full time, field-based position. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements and Skills: * RN required * Four-year degree preferred * Current license in good standing * Dermatology / Biologic injectable experience helpful * Home health care experience helpful * Excellent presentations skills * Valid driver's license * Ability to manage multiple tasks2012-05-19 04:50:39United StatesQuintilesTexas1207471TXDallas, TX28814277http://quintiles.jobs/xml/28814277/jobUSAFort WorthTitle: Patient Ambassador - Fort Worth, TX 4532 Location: USA-Texas-Fort Worth Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Patient Ambassadors to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Patient Ambassador The Patient Ambassador will provide focused home-based patient education regarding treatment of Psoriasis. They will also provide specialized education and training to home health care agencies, physicians, nursing and office staff within a defined geographic region and conduct training presentations to Psoriasis support groups regarding treatment of the disease. There will be occasional travel overnight for meeting attendance. This is a full time, field-based position. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements and Skills: * RN required * Four-year degree preferred * Current license in good standing * Dermatology / Biologic injectable experience helpful * Home health care experience helpful * Excellent presentations skills * Valid driver's license * Ability to manage multiple tasks2012-05-19 04:50:39United StatesQuintilesTexas1207472TXFort Worth, TX28814276http://quintiles.jobs/xml/28814276/jobUSAResearch Triangle ParkTitle: Site Intelligence Proj Spec 2 Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE To work as an integral member of the strategic site intelligence and global feasibility solutions team leading actionable analyses and reports on various investigator and clinical data attributes RESPONSIBILITIES · Support efforts to identify investigators through strategic site identification methods · Support project efforts through complex data mining of internal databases by collating data, review of investigators for quality assurance and compiling reports for senior management · Ascertain potential performance at site and make decision on recommendation of site to internal and external customer · Prepare for strategy calls by research into therapeutic areas using internal databases, scientific literature, external data searches and expert medical knowledge to provide background information · Support the design, implementation and analysis of protocol-specific questionnaires for collection of global feasibility information for individual countries and sites in order to determine patient populations and protocol suitability · Develop systems and data collection tools in Excel to support the collection of associated metrics for feasibility and strategic site intelligence · Coordinate the collection and analysis of global feasibility information to meet the challenging timelines of the proposal process and independent feasibility assessments · Undertake therapeutic training, as necessary, and keep abreast of developments in clinical research generally · Identify and proactively share best practice across the team to drive performance including the creation of clear and succinct guidance documents · Clean, compile and analyze data from various internal and external data sources · Successfully complete detailed data analyses and visualizations from ambiguous problem statements with minimal work direction · Create clear and concise data visualizations, presentations and reports with minimal work direction · Collaborate effectively with other team members · Actively participate in team and project meetings REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Good knowledge of medical terminology, GCP, FDA regulations, and Drug Development process · Extensive experience in data compilation, analysis and visualization · Expert use of Microsoft Excel including pivot tables, data validation, lookups, charting (VBA a plus) · Proficient use of all other Microsoft Office tools · Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment · Above average interpersonal and organizational skills · Ability to handle multiple tasks with varying deadlines · Ability to maintain confidentiality · Ability to maintain effective working relationships with coworkers and managers · Fluent in local language · Fluent in written English language MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's Degree in scientific or healthcare discipline and a minimum of 5 years related experience in clinical research; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS · Extensive use of keyboard requiring repetitive motion of fingers · Extensive use of telephone and face-to-face communication requiring accurate perception of speech · Regular sitting for extended periods of time · May require occasional travel2012-05-19 04:50:38United StatesQuintilesNorth Carolina1207300NCResearch Triangle Park, NC28814274http://quintiles.jobs/xml/28814274/jobUSAReadingTitle: Primary Care Sales Representative - Reading, PA 7069 Location: USA-Pennsylvania Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:28United StatesQuintilesPennsylvania1207440PAReading, PA28814273http://quintiles.jobs/xml/28814273/jobUSATallahasseeTitle: Primary Care Sales Representative - Tallahassee, FL 7069 Location: USA-Florida-Tallahassee Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:27United StatesQuintilesFlorida1207442FLTallahassee, FL28814270http://quintiles.jobs/xml/28814270/jobUSAMesaTitle: Primary Care Sales Representative - Mesa, AZ 7069 Location: USA-Arizona-Mesa Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:27United StatesQuintilesArizona1207445AZMesa, AZ28814271http://quintiles.jobs/xml/28814271/jobUSAMilwaukeeTitle: Primary Care Sales Representative - Milwaukee South, WI 7069 Location: USA-Wisconsin-Milwaukee Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:27United StatesQuintilesWisconsin1207446WIMilwaukee, WI28814272http://quintiles.jobs/xml/28814272/jobUSAPalm BeachTitle: Primary Care Sales Representative - Palm Beach, FL 7069 Location: USA-Florida-Palm Beach Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:26United StatesQuintilesFlorida1207441FLPalm Beach, FL28814269http://quintiles.jobs/xml/28814269/jobUSALawrencevilleTitle: Primary Care Sales Representative - Lawrenceville, GA 7069 Location: USA-Georgia-Lawrenceville Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:26United StatesQuintilesGeorgia1207443GALawrenceville, GA28814267http://quintiles.jobs/xml/28814267/jobUSAOklahoma CityTitle: Primary Care Sales Representative - Oklahoma City South, OK 7069 Location: USA-Oklahoma-Oklahoma City Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-19 04:50:26United StatesQuintilesOklahoma1207444OKOklahoma City, OK28814268http://quintiles.jobs/xml/28814268/jobUSAAlbanyTitle: Patient Ambassador - Albany, NY 4532 Location: USA-New York-Albany Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Patient Ambassadors to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Patient Ambassador The Patient Ambassador will provide focused home-based patient education regarding treatment of Psoriasis. They will also provide specialized education and training to home health care agencies, physicians, nursing and office staff within a defined geographic region and conduct training presentations to Psoriasis support groups regarding treatment of the disease. There will be occasional travel overnight for meeting attendance. This is a full time, field-based position. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements and Skills: * RN required * Four-year degree preferred * Current license in good standing * Dermatology / Biologic injectable experience helpful * Home health care experience helpful * Excellent presentations skills * Valid driver's license * Ability to manage multiple tasks2012-05-19 04:50:23United StatesQuintilesNew York1207466NYAlbany, NY28814266http://quintiles.jobs/xml/28814266/jobUSAManhattanTitle: Patient Ambassador - Manhattan, NY 4532 Location: USA-New York-Manhattan Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Patient Ambassadors to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Patient Ambassador The Patient Ambassador will provide focused home-based patient education regarding treatment of Psoriasis. They will also provide specialized education and training to home health care agencies, physicians, nursing and office staff within a defined geographic region and conduct training presentations to Psoriasis support groups regarding treatment of the disease. There will be occasional travel overnight for meeting attendance. This is a full time, field-based position. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements and Skills: * RN required * Four-year degree preferred * Current license in good standing * Dermatology / Biologic injectable experience helpful * Home health care experience helpful * Excellent presentations skills * Valid driver's license * Ability to manage multiple tasks2012-05-19 04:50:22United StatesQuintilesNew York1207468NYManhattan, NY28814265http://quintiles.jobs/xml/28814265/jobUSASaint LouisTitle: Patient Ambassador - St. Louis, MO 4532 Location: USA-Missouri-Saint Louis Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Patient Ambassadors to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Patient Ambassador The Patient Ambassador will provide focused home-based patient education regarding treatment of Psoriasis. They will also provide specialized education and training to home health care agencies, physicians, nursing and office staff within a defined geographic region and conduct training presentations to Psoriasis support groups regarding treatment of the disease. There will be occasional travel overnight for meeting attendance. This is a full time, field-based position. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements and Skills: * RN required * Four-year degree preferred * Current license in good standing * Dermatology / Biologic injectable experience helpful * Home health care experience helpful * Excellent presentations skills * Valid driver's license * Ability to manage multiple tasks2012-05-19 04:50:22United StatesQuintilesMissouri1207469MOSaint Louis, MO28814264http://quintiles.jobs/xml/28814264/jobUSACambridgeTitle: AD, CDM Location: USA-Massachusetts-Cambridge Other Locations: PURPOSE Lead Functional Department of Data Management professionals to efficiently produce databases that meet customer requirements. RESPONSIBILITIES • Manage a Functional Department of Data Management staff. Size of team could vary from 15-40, and may be a first-line or second-line management position. • Define and prioritize resource requirements and manage resource assignments across projects. • Monitor and manage utilization and productivity of Functional Department. • Assess and document competency of staff to satisfy position responsibilities. Regularly set goals and evaluates and documents performance. • Define recruiting strategies and staffing needs based on hard backlog. • Define and implement department objectives consistent with broader office company objectives. • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF (case report form), database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. • Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. • Monitor quality and efficiency across projects to identify trends and opportunities for improvements. Ensure sharing of learning across projects. • Participate in defining strategies for new processes and technology at either regional or global level. • Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. • Define and implement training/professional development strategy for Functional Department. • Mentor staff members to develop Data Management process, system, and drug development expertise. • Manage relationship with customer at both the project team level and with functional peers. • Provide operational input into proposals and scope of work. Participate in proposal defenses. Provide input to costing algorithms, particularly at the customer level. • Attend customer meetings and lead discussions of project requirements and strategic planning. • Ensure compliance of work with project's scope of work. • Actively assess and help manage project realization. • Ensure project milestones are met according to agreed upon timelines with high quality. • May serve as a Data Management Customer Liaison for one or more customers. • Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Advanced knowledge of Data Management processes and systems • Solid understanding of clinical drug development process • Technical programming skills • Outstanding written and oral communication skills • Proven leadership skills • Outstanding problem solving skills • Excellent interpersonal skills • Excellent organizational skills and demonstrated ability to delegate appropriately • Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences or related field, or nursing qualification with 10 years of relevant work experience including substantial people management experience; or equivalent combination of education, training and experience PHYSICIAL REQUIREMENTS • Extensive use of telephone and face-to-face communication requiring accurate perception of speech • Extensive use of keyboard requiring repetitive motion of fingers • Regular sitting for extended periods of time2012-05-18 03:58:56United StatesQuintilesMassachusetts1207387MACambridge, MA28784370http://quintiles.jobs/xml/28784370/jobUSASan JoseTitle: Pharmaceutical Sales Representative, Entry Level - San Jose, CA 6579 Location: USA-California-San Jose Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Entry LevelPharmaceutical Sales Representativesto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting Alcon, the global leader in eye care. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. Pharmaceutical Sales Representative The Pharmaceutical Representative targets, promotes and sells over the counter products to specialists in assigned therapeutic area. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Pharmaceutical Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. This is an outstanding entry level opportunity for a college graduate to break into the pharmaceutical market with an industry leader! Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required. · Business-to-Business sales experience strongly preferred. · Demonstrated leadership in community, professional and/or college organizations · Strong verbal, interpersonal and listening skills · Demonstrated self-starter and highly motivated · Demonstrated ability to work as a team member and effectively communicate within different levels of an organization · Demonstrated ability to work independently to deliver results · Demonstrated technical aptitude and computer skills essential Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-05-18 03:58:33United StatesQuintilesCalifornia1207381CASan Jose, CA28784367http://quintiles.jobs/xml/28784367/jobUSAOverland ParkTitle: Assoc Records Mgmt Specialist 1 (eTMF) Location: USA-Kansas-Overland Park Other Locations: PURPOSE Perform roles for one of the following possitions: Document Management Specialist 2, Electronic Document QC or Review QC. Serve as the liaison between the records center and user departments regarding information and records issues. Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems. RESPONSIBILITIES * Function as team leader for records management projects. Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs. * Coordinate the retrieval of records requested by users and prepare closed studies to final destination within agreed timelines. * Assist management with the implementation of strategic goals, plans, cost proposals, and required resources for records management projects. * Train team members on records management tasks, policies, and procedures. * Monitor filing accuracy and compliance to Quintiles or customer file plans and SOPs where applicable. * Interface with departments to support retrieval projects and ensure information needs are met. Serve as primary contact for internal/external clients. * Recommend changes or revisions to records retention schedules. Maintain accurate indices and databases to control inventory. * Coordinate transfer, recall, and disposition of records to commercial records storage centers. Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment. * Maintain records center security to protect record integrity by ensuring compliance to SOPs. * Collect data and assist in the preparation of statistical reports for management on all phases of record center operations. * Conduct and manage imaging/scanning eTMF processes and train staff on imaging/scanning eTMF processes. * Design and administer records management systems and processes REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Knowledge of technology applications relevant to records center environments. * General knowledge of computer technology and software programs. * Knowledge of facilities operations. * Extensive knowledge of records management laws and regulations. * Strong organizational, planning, and decision making skills. * Excellent oral and written communication skills. * Ability to perceive and analyze problems, develop solutions, and make sound management decisions. * Ability to manage and lead others. * Ability to work effectively with others. * Ability to work with outside vendors. * Ability to establish and maintain effective working relationships with coworkers, managers and clients * Extensive knowledge of Regulatory/Clinical documents * Extensive experience working in Electronic systems MINIMUM REQUIRED EDUCATION AND EXPERIENCE High School and 4 years' experience working in a records management environment; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS * Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time. * Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms. * Position is required to stoop, kneel, or climb. * Unaided lifting of objects up to 40 pounds. * Use of telephone and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time2012-05-18 03:58:21United StatesQuintilesKansas1207240KSOverland Park, KS28784365http://quintiles.jobs/xml/28784365/jobUSAResearch Triangle ParkTitle: Manager, Payroll - US Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. We are seeking a Manager for our Payroll department, to be located in our Global Corporate Headquarters in RTP, NC. US Payroll currently is responsible for paying 8,000 people twice per month. The payroll manager will have a team of 8 direct reports, all based in RTP. Ideal candidate should have 10 years of payroll management experience, and a minimum of 3 years of line management/supervisory experience. Incumbent will be responsible for delivering Payroll services to agreed timelines and accuracy; whileenforcing and complying with Quintiles financial policies and standard processes. RESPONSIBILITIES * Overall responsibility for payroll group; manage the Payroll Function in the Professional Services Center(PSC). * Manage staff in accordance with organization's policies and applicable legislation. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; addressing employee relations issues and resolving problems. * Manage staff by assigning them with their responsibilities when necessary, by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. * May participate in the selection and on-boarding process for new staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems' access and training to complete job responsibilities. * Achieve defined performance levels as agreed in Service Level Agreements (SLAs). * Manage the day to day relationship with the payroll service provider, Ceridian. * Maintain all statutory reporting relating to payroll. * Seek customer driven enhancement of services which will deliver PSC performance improvement. * Produce and maintain Payroll procedures and participate in project work for new processes. * Manage organizational structure for Payroll codings to General Ledger Financials. * Provide support to internal customers on Legislation / Policy changes. * Responsible for payroll department budget. * Manage staff in accordance with policies and applicable regulations, including planning, assigning, and directing work. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Excellent customer service skills * Knowledge of Microsoft Office applications * Strong analytical and numerical skills * Ability to identify financial issues, develop and execute mitigating actions * Effective verbal and written communication skills * Confidentiality * Strong influencing skills * Management of others * Ability to prioritize and coordinate multiple work requirements to meet deadlines * Ability to establish and maintain effective working relationships with co-workers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelors degree in Accounting or related field with 10 years' Payroll experience, including 3 years in a management / supervisory role highly preferred; or equivalent combination of education, training and experience.2012-05-18 03:58:18United StatesQuintilesNorth Carolina1207291NCResearch Triangle Park, NC28784364http://quintiles.jobs/xml/28784364/jobUSAOverland ParkTitle: Assoc Records Mgmt Specialist 2 (Quality Specialist) Location: USA-Kansas-Overland Park Other Locations: PURPOSE Serve as the liaison between the records management and user departments regarding information and records issues. Ensure that project timelines are met and facilitate the orderly imaging, transfer, retention, and disposition of various project-related and business records. Administer records management systems. RESPONSIBILITIES * Function as team leader for records management projects. Ensure project deadlines, commitments, and goals are met by monitoring team's daily outputs. * Coordinate the retrieval of records requested by users and prepare closed studies for transfer to clients. * Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects. * Train team members on records management tasks, policies, and procedures. * Monitor filing accuracy and compliance to Quintiles or customer file plans and SOPs. * Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates. * Interface with departments to support retrieval projects and ensure information needs are met. Serve as primary contact for clients. * Recommend changes or revisions to records retention schedules. Maintain accurate indices and databases to control inventory. * Coordinate transfer, recall, and disposition of records to commercial records storage centers. Oversee disposal of obsolete records and ensure efficient maintenance of records storage space, supplies, and equipment. * Maintain records center security to protect record integrity by ensuring compliance to SOPs. * Collect data and assist in the preparation of statistical reports for management on all phases of record management operations. * Conduct and manage imaging / eTMF processes and train staff on imaging / eTMF processes. * Design and administer records management systems REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Knowledge of technology applications relevant to records management environments. * General knowledge of computer technology and software programs. * Knowledge of facilities operations. * Extensive knowledge of records management laws and regulations. * Strong organizational, planning and decision making skills. * Excellent oral and written communication skills. * Ability to perceive and analyze problems, develop solutions, and make sound management decisions. * Ability to manage and lead others. * Ability to work effectively with others. * Ability to work with outside vendors. * Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE High School diploma and 5 years' experience working in a records management environment; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS * Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time. * Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms. * Position is required to stoop, kneel, or climb. * Unaided lifting of objects up to 40 pounds. * Use of telephone and face-to-face communication requiring accurate perception of speech * Regular sitting for extended periods of time2012-05-18 03:58:18United StatesQuintilesKansas1207338KSOverland Park, KS28784363http://quintiles.jobs/xml/28784363/jobUSAParsippanyTitle: Associate Director, Medical Communications, Parsippany, NJ Location: USA-New Jersey-Parsippany Other Locations: Associate Director - Medical Communications - US or UK based Quintiles currently has an exciting opportunity for a Account Director to take a key role in the Medical Communications team. The ideal candidate for this role can either be based in either in Parsippany, NJ, Raleigh, NC or Berkshire, UK. We are looking for an Associate Director level Medical Communications specialist to manage a team of client services and business development professionals within the Medical Communications Division. You will be accountable for the planning, execution and measurement of a portfolio of projects and programs to the client's satisfaction, ensuring strategically-aligned, quality deliverables on time and within budget. Other responsibilities include: * Responsible for securing and retaining business by providing professional, consultative, proactive and strategic support to decision-makers and influencers within existing and new customers typically working with our larger or more complex accounts. * Financially accountable for overall performance of assigned team including financial forecasting, revenue and profitability analysis and proactively initiating actions to maximize growth opportunities. * Responsible for the growth of existing account portfolio, forming senior-level relationships within relevant client company(ies) and growing these beyond direct clients to senior customer leaders and procurement teams, resulting in increased new business opportunities. * Provide leadership to internal account teams and ensure high quality senior strategic council to clients at all times. Provide strategic direction of accounts encompassing all aspects of program/project development through thorough knowledge of market issues, company's and project's overall strategic objectives. * Take responsibility for the team's new business target, working with Director to develop and implement new business strategies and providing senior leadership of multiple new business opportunities. * Work with Directors to identify and grow new service offerings, leading both client services and business development team members to generate new leads and pitch wins, including participating in business development brainstorming meetings; developing new business presentations and proposals; attending business pitches, generating new business leads. * Navigate Quintiles offerings and facilitate delivery of high-quality, cross functional solutions to existing and new customers, and maintain strong network across Quintiles stakeholders and represent QMC on cross-business unit strategic initiatives and service offering development. * Assess the scope of all assigned accounts and identify the range and depth of support necessary for achieving account objectives. Quintiles Medical Communications is an international medical communications agency that develops and produces a broad range of communications programs and materials on behalf of pharmaceutical industry. Working with our pharmaceutical clients, our activities include organizing international symposia, developing educational programs for physicians and patients, producing clinical trial investigator and participant support materials, and developing print/digital materials ranging from sales aids to peer-reviewed publications. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! EOE QUALIFICATIONS * Bachelor's degree in medicine, pharmacy, life sciences, marketing or other relevant area and experience within the pharmaceutical industry or agency environment or equivalent combination of education, training and experience. * Capable of working independently on all aspects of Pharmaceutical Marketing * Strong knowledge of all aspects of Pharmaceutical marketing * Exceptional leadership, presentation and influencing skills * Definite team player with high level of stress tolerance * Demonstrable experience in managing teams in a matrixed, multi regional organization delivering global initiatives * Highly experienced in dealing with complex and day to day employment scenarios * Ability to work creatively in a fast paced environment maintaining flexibility and changing priorities to meeting demanding timelines. * Excellent communication, interpersonal and customer service skills * Strong financial, analytical and problem solving skills with the ability to develop and articulate recommendations and solutions based on this analysis. * Strong organizational, planning, project management and logistics skills. * Strong software and computer skills, including MS Office applications. * Must live locally and be office-based; occasional travel required2012-05-18 03:58:06United StatesQuintilesNew Jersey1204683NJParsippany, NJ28784362http://quintiles.jobs/xml/28784362/jobUSAParsippanyTitle: Account Director, Medical Communications, Parsippany, NJ Location: USA-New Jersey-Parsippany Other Locations: Account Director - Medical Communications - US or UK based Quintiles currently has an exciting opportunity for a Account Director to take a key role in the Medical Communications team. The ideal candidate for this role can either be based in either in Parsippany, NJ, Raleigh, NC or Berkshire, UK. Reporting to the Associate Director, you will be the key client lead for at least two accounts and be responsible for strategic planning and programming, budget oversight, team resourcing and internal and external stakeholder liaison. Core to the role is the ability to generate organic growth on existing business and the ability to participate in new business pitches. International communications experience is necessary for this role and UK experience is a plus, along with a scientific background combined with medical communications or healthcare/PR agency experience. Successful candidates will have excellent IT skills, enjoy developing business, collaboration and interest in a fast paced specialist organization who will enjoy the backing of a Global company. This is a great opportunity for career development. Quintiles Medical Communications is an international medical communications agency that develops and produces a broad range of communications programs and materials on behalf of pharmaceutical industry. Working with our pharmaceutical clients, our activities include organizing international symposia, developing educational programs for physicians and patients, producing clinical trial investigator and participant support materials, and developing print/digital materials ranging from sales aids to peer-reviewed publications. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! EOE QUALIFICATIONS · Experience within the pharmaceutical industry or Medical Communications or Healthcare/PR agency environment. · Pharmaceutical and scientific background, ideally · International communications experience - preferred · Financial project management. · Pharmaceutical strategic marketing programs. · Implementation and monitoring of PR and Publication Planning projects. · Line management experience - preferred. · Bachelor's degree, or equivalent, in medicine, pharmacy, life sciences, marketing or other relevant area. · Must live locally and be office-based; occasional travel required2012-05-18 03:58:06United StatesQuintilesNew Jersey1204684NJParsippany, NJ28784361http://quintiles.jobs/xml/28784361/jobUSAOverland ParkTitle: Records Mgmt Assoc 1 (Document Management Specialist 1) Location: USA-Kansas-Overland Park Other Locations: PURPOSE Coordinate operations and provide support to the records or imaging center. Provide reference services to all departments and personnel and distribute incoming information for integration into systems. RESPONSIBILITIES * Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures. Includes usage of scanning equipment. * Conduct imaging/scanning processes and train imaging/scanning processes * Provide reference services to internal clients in accordance to SOPs and by maintaining accurate charge-out systems. * Sort and classify coded material for filing. Create files according to established classification system. * Maintain log and enter metadata in database to track status and facilitate accurate retrieval of information. * Coordinate work flow through assignment of tasks and establishment of procedures. * File, maintain and process reports, collections, and validations where applicable. * Maintain logs and indexes to provide status of information and assist in the collection of data for preparation of monthly metric reports. * Assist in the training of new team members on departmental procedures. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Knowledge of word processing, spreadsheets, and database applications. * Excellent oral and written communication skills. * Strong organization and planning skills. * Outstanding client service skills. * Excellent interpersonal skills. * Ability to handle multiple tasks within defined timelines and significant direction. * Ability to work with others. * Ability to remain focused with regards to details. * Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE High school diploma with 2 years experience in an office environment; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS * Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time. * Position is required to stand, walk, sit, use hands to manipulate, handle or feel, and reach with hands and arms.2012-05-18 03:58:05United StatesQuintilesKansas1207307KSOverland Park, KS28784360http://quintiles.jobs/xml/28784360/jobUSABostonTitle: Project Team Lead / Clinical Project Manager - Northeast Region Location: USA-Massachusetts-Boston Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We currently have an opening for a Clinical Project Manager. This position can be home-based anywhere in the US. The Clinical Project Manager will manage the execution of the assigned regionally-based clinical study(ies) per Contract, from initiation through closeout. You will ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. Specific responsibilities include: * Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. * Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. * Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. * Collect information on team performance against contract, customer expectations, and project baselines. * Lead problem solving and resolution efforts to include management of risk, contingencies and issues. * Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. * Provide input for the development of proposals for new work and manage project budgets. * Provide input to line managers of their project team members' performance relative to project tasks. * Prepare and present project information at internal and external meetings. * Participate in proposal development and in the bid-defense process with guidance and supervision. * Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Good therapeutic and protocol knowledge * Strong communication and interpersonal skills, including good command of English language * Good problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good teamwork skills * Excellent customer service skills * Good presentation skills * Good judgment * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience.2012-05-17 03:50:24United StatesQuintilesMassachusetts1207350MABoston, MA28757089http://quintiles.jobs/xml/28757089/jobUSAOrlandoTitle: Regional Account Manager - Neurology Orlando, FL 6427 Location: USA-Florida-Orlando Other Locations: USA-Florida-Jacksonville As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Regional Account Managers to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Regional Account Manager The Regional Account Manager targets, promotes and sells a injectable neurology product to Neurologist and other healthcare providers. The Regional Account Manager manages their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. They provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE ·4 year Bachelor's degree required ·Ability to understand and sell an injectable buy and bill product required ·3 to 5 yrs selling experience in specialty sales or hospital environment required, with neurology specialty sales a strong plus ·The ideal field based Regional account manager will possess expertise in the areas of injectable sales, or diagnostics and may possess a clinical background as well. ·Understanding of commercial and government reimbursement ·Understanding of Carrier and Fiscal intermediaries ·Understanding of ASP 6% ·Managed markets experience a plus ·Strong past account management skills in the specialty arena ·Understanding of Specialty pharmacy a plus ·Understanding of retail pharmacy ·Past track record of success. Competencies ·Demonstrated analytical skills ·Demonstrated Business Acumen ·Demonstrated success in persuasion, influence and negotiation skills ·Demonstrated leadership ability ·Demonstrated ability to apply technical/scientific knowledge ·Flexibility to learn new products over time ·Knowledge of and experience with the selling process ·Initiative & execution-oriented ·Teamwork2012-05-17 03:50:19United StatesQuintilesFlorida1207359FLOrlando, FL28757088http://quintiles.jobs/xml/28757088/jobUSAResearch Triangle ParkTitle: Financial Analyst 2 Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is a fully integrated Bio pharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 26,000 engaged professionals in over 63 countries are committed to making people healthier. A career at Quintiles puts you at the corporate center of the leading worldwide pharmaceutical services organization. If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. PURPOSE Quintiles Global Finance has a unique opportunity within the corporate Finance Department to work as a Financial Analyst II, supporting several corporate overhead departments. In this position the person will assist with the coordination and summarization of and participate in monthly discussions for the review of departmental financial performance, assist overheads in managing their business, provide management with key monthly cost analysis, explain high level variances and prepare forecasts and budgets. RESPONSIBILITIES * Perform analysis of monthly expenses. * Create monthly reports and understand/ explain key variances on a monthly,quarterly and yearly basis. * Coordinate tasks related to the forecasting/budgeting process for selected Central Overheads. * Maintain detailed understanding of internal customer requirements and develop processes that will meet or exceed these requirements. * Coordinate tasks related to the administration of the financial accounting system. * Be familiar with, and ensure compliance with, internal financial accounting procedures and policies. * Communicate with Global/Local Finance and Overhead Departments. * Maintain Capital Expenditure Reports/Analysis. * Perform other duties and Ad Hoc projects as assigned. The successful candidate will have excellent interpersonal and customer service skills, strong verbal and written communication skills and the desire to learn the company and work in a changing and fast-paced environment. Candidate will use Excel extensively and must be highly proficient with pivot tables and working with formulas. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Background with financial modules * Knowledge of General Ledger accounting * Excellent analytical abilities * Technical accounting skills * Proficient use of excel * Ability to identify financial issues and execute mitigating actions * Ability to prioritize and coordinate multiple work requirements to meet deadlines * Ability to establish and maintain effective working relationships with co-workers, managers and clients * Hyperion experience a plus MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelors Degree in Finance/Accounting * Masters/MBA/CPA a plus * 5 years of relevant work experience2012-05-17 03:50:16United StatesQuintilesNorth Carolina1206928NCResearch Triangle Park, NC28757087http://quintiles.jobs/xml/28757087/jobUSAHawthorneTitle: Data Analyst - Continuing Medical Education Location: USA-New York-Hawthorne Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. New regulatory scrutiny and tightening industry guidelines have led to tremendous changes in the way continuing medical education programs are planned, funded, executed, and evaluated. At Quintiles Medical Education, we are helping the industry move ahead confidently in this new era. Quintiles Medical Education provides scientific validity, clinical expertise, and quantitative results to establish educational programs, deepen clinical competencies, align with adult learning principles and improve quality care. If you want to work for a global, fast-paced organization dedicated to improving the advancement of medicines, Quintiles is the place for you. Apply now for our Data Analyst role within our Quintiles Medical Education group based out of our Hawthorne, NY office. PURPOSE Assists outcomes staff with the analysis of data and creation of reports for internal Quintiles customers and external clients. Will have input in the innovation of data collection and reporting techniques and procedures. Assists with maintenance of accreditation requirements and annual reporting to accrediting bodies. RESPONSIBILITIES · Supports Director of Education and Outcomes in managing requests. Examples include but are not limited to the following: internal requests for project related data, external client reporting, review of project materials for compliance with accreditation requirements, identifying improvements in the outcomes and compliance process · Tracks project timelines and reporting requests, with senior review. · Interacts with internal clients. May have some external interactions, mostly directed by senior staff. · Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff. · Keeps abreast of current data, trends, regulatory knowledge, developments and important advances in the CME industry · Complies with Company SOP's and participates in the implementation of new SOP's. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. · Ability to analyze large sets of data and identify strategically important subsets · Ability to work on several projects at once while balancing multiple and overlapping timelines. · Ability to assess workload and suggest prioritization to senior staff. · Demonstrated abilities in collaboration with others and independent thought. · Careful attention to detail and accuracy. · Must be computer literate with advanced proficiency in Microsoft Word and PowerPoint. · Ability to establish and maintain effective working relationships with coworkers, managers, vendors and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree with a minimum of 2 years experience in data analysis and reporting; or equivalent combination of education, training and experience2012-05-17 03:49:57United StatesQuintilesNew York1207293NYHawthorne, NY28757085http://quintiles.jobs/xml/28757085/jobUSARedondo BeachTitle: Primary Care Sales Representative - Redondo Beach, CA 7069 Location: USA-California-Redondo Beach Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-17 03:49:57United StatesQuintilesCalifornia1207335CARedondo Beach, CA28757084http://quintiles.jobs/xml/28757084/jobUSAHawthorneTitle: Web Strategist/ Developer - Continuing Medical Education Location: USA-New York-Hawthorne Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. New regulatory scrutiny and tightening industry guidelines have led to tremendous changes in the way continuing medical education programs are planned, funded, executed, and evaluated. At Quintiles Medical Education, we are helping the industry move ahead confidently in this new era. Quintiles Medical Education provides scientific validity, clinical expertise, and quantitative results to establish educational programs, deepen clinical competencies, align with adult learning principles and improve quality care. If you want to work for a global, fast-paced organization dedicated to improving the advancement of medicines, Quintiles is the place for you. Apply now for our Web Strategist/Developer role within our Quintiles Medical Education group based out of our Hawthorne, NY office. Applicant must have experience and working knowledge of web development technologies: * ASP * .NET * SQL server * JavaScript/JQuery/AJAX/XML * VBscript * HTML/XHTML/CSS * SEO * HTML5 apps * E learning software Adobe presenter, Captivate * Bachelor's degree in IT related field and 4 years work experience, or equivalent combination of education, training and experience. * Candidate must also demonstrate previous experience working on cutting-edge, custom Web sites and e-marketing applications, and have built sophisticated framework based websites. * Strong problem solving skills. * Troubleshoot and solve technical issues and problems within the system. * Responsive and flexible to evolving responsibilities and changing environment. * Ability to work as a member of a team, but with a specific independent role. * Excellent English written and verbal communication skills.2012-05-17 03:49:44United StatesQuintilesNew York1207286NYHawthorne, NY28757082http://quintiles.jobs/xml/28757082/jobUSANew HavenTitle: Cardiology Specialty Sales Representative - New Haven, CT 6594 Location: USA-Connecticut Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-16 06:04:59United StatesQuintilesConnecticut1207299CTNew Haven, CT28727435http://quintiles.jobs/xml/28727435/jobUSAResearch Triangle ParkTitle: Sr Reg Doc Coord/ RTP, North Carolina Location: USA-North Carolina-Research Triangle Park Other Locations: TITLE:Sr Reg Doc Coordinator PURPOSE Supports the preparation of regulatory documents and submissions. May provide support to department staff. May coordinate specific regulatory tasks, under guidance of senior staff. RESPONSIBILITIES • Assists the regulatory team in the preparation, handling, distribution, filing and archiving of regulatory documentation according to the scope of work and standard operating procedures. • Reviews documents for completeness, consistency and accuracy, under guidance of senior staff and interacts with project team members to assure completeness, as necessary. • May create and prepare client deliverable documents using reporting tools. • May conduct QC review of documents prepared by the regulatory unit, project team or client, under guidance of senior staff. • May assist with the tracking of regulatory documentation utilizing relevant tools as appropriate. • May provide support to various tasks, for example meeting coordination, minute taking, travel arrangements, faxing, copying, expense reporting. • May assist with the preparation and participation of audits relating to Projects and Systems, under guidance of senior staff. • May interact with internal and external clients, under guidance of senior staff. • Perform other tasks or assignments, as delegated by Regulatory management. Create client specific reports to fulfill the requirements of multiple government regulations. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Good interpersonal communication and organization skills Superior word processing skills and detailed knowledge of core software packages, including MS Office applications(Excel skills are preferred) Good attention to detail and accuracy General awareness and knowledge of applicable regulatory requirements Ability to work onmultipleprojectswith direction from senior staff as appropriate Ability to follow SOPs Ability to establish and maintain good working relationships with co-workers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE High school diploma/certificate or educational equivalent; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Extensive use of copier and fax machines requiring a significant amount of standing Regular sitting for extended periods of time Occasional travel may be required2012-05-16 06:04:50United StatesQuintilesNorth Carolina1207271NCResearch Triangle Park, NC28727434http://quintiles.jobs/xml/28727434/jobUSACincinnatiTitle: Pharmaceutical Sales Representative - Cincinnati South, OH 6531 Location: USA-Ohio-Cincinnati Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representativeto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting Purdue Pharma L.P., an industry leader committed to improving patient's lives and serving the healthcare community. Pharmaceutical Sales Representative The Sales Representative will target, promote and sell our partner's therapeutic products to general practitioners and other healthcare providers as directed. The Sales Representative manages an assigned territory in order to grow our customer's business among a targeted physician audience and further develop relationships with new physician groups to achieve customer objectives. The Sales Representative will also be responsible for providing quality consultative services, coordinating and integrating outside alliances and providing resources to fit customer needs. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required · A minimum overall undergraduate college GPA of 2.8/4.0 · A minimum of 1.5 years of pharmaceutical sales experience · A documented track record of success · Ability to demonstrate proven sales performance over time · Must reside within the territory in an appropriate location to efficiently work the territory · Strong work ethic and customer focus orientation · Excellent communication and organization skills · Have a valid operator's license and be insurable. Preferred Skill Set: · Have interest, desire and ability for upward career growth · Have 2-4 years of successful Pharmaceutical experience · Have experience in the insomnia market · Have documented success launching a new product Competencies · Demonstrated analytical skills · Demonstrated Business Acumen · Demonstrated success in persuasion, influence and negotiation skills · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Knowledge of and experience with the selling process · Initiative & execution-oriented · Teamwork2012-05-16 06:04:45United StatesQuintilesOhio1207288OHCincinnati, OH28727433http://quintiles.jobs/xml/28727433/jobUSANoneTitle: Pharmaceutical Sales Representative, Entry Level Queens Central - 6579 Location: USA-New York Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Entry LevelPharmaceutical Sales Representativesto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting Alcon, the global leader in eye care. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. Pharmaceutical Sales Representative The Pharmaceutical Representative targets, promotes and sells over the counter products to specialists in assigned therapeutic area. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Pharmaceutical Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. This is an outstanding entry level opportunity for a college graduate to break into the pharmaceutical market with an industry leader! Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required. · Business-to-Business sales experience strongly preferred. · Demonstrated leadership in community, professional and/or college organizations · Strong verbal, interpersonal and listening skills · Demonstrated self-starter and highly motivated · Demonstrated ability to work as a team member and effectively communicate within different levels of an organization · Demonstrated ability to work independently to deliver results · Demonstrated technical aptitude and computer skills essential 100% travel required Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-05-16 06:04:44United StatesQuintilesNew York1207289NYNew York, USA28727432http://quintiles.jobs/xml/28727432/jobUSAFargoTitle: Pharmaceutical Sales Representative - Internal Medicine Fargo, ND 6517 Location: USA-North Dakota-Fargo Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Internal Medicine Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making o v er 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Internal Medicine Pharmaceutical Sales Representative The primary objective of the sales representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience ·4 year Bachelor degree required ·Minimum 3 years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required ·Excellent written and oral communication skills required ·Ability to travel as necessary (some overnights and weekends) is required ·Prior experience in pain management, cardiovascular and/or metabolic/diabetes therapeutic area, gastrointestinal disorders and therapies or other internal medicine areas preferred ·Documented sales results ·Participation in management development program preferred ·Residence within the current geography or willingness to relocate to the current geography is required Competencies ·Performance and results driven ·Customer expertise ·Professional credibility ·Business Insight ·Collaboration ·Thrives in Ambiguity2012-05-16 06:04:44United StatesQuintilesNorth Dakota1207303NDFargo, ND28727431http://quintiles.jobs/xml/28727431/jobUSARaleighTitle: Pharmaceutical Sales Representative - Internal Medicine Raleigh East, NC 6517 Location: USA-North Carolina-Raleigh Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Internal Medicine Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making o v er 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Internal Medicine Pharmaceutical Sales Representative The primary objective of the sales representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience ·4 year Bachelor degree required ·Minimum 3 years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required ·Excellent written and oral communication skills required ·Ability to travel as necessary (some overnights and weekends) is required ·Prior experience in pain management, cardiovascular and/or metabolic/diabetes therapeutic area, gastrointestinal disorders and therapies or other internal medicine areas preferred ·Documented sales results ·Participation in management development program preferred ·Residence within the current geography or willingness to relocate to the current geography is required Competencies ·Performance and results driven ·Customer expertise ·Professional credibility ·Business Insight ·Collaboration ·Thrives in Ambiguity2012-05-16 06:04:43United StatesQuintilesNorth Carolina1207301NCRaleigh, NC28727430http://quintiles.jobs/xml/28727430/jobUSAIthacaTitle: LC/MS Post Doc Research Scientist Location: USA-New York-Ithaca Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 23,000 engaged professionals in over 60 countries are committed to making people healthier. Join us as we define TheNewHealth. We are currently seeking industrial post doctoral researcher at Advion Bioanalytical Labs, A Quintiles Company, to carry out research to explore the use of multi-dimensional LC/LC/MS/MS to achieve sub-picogram/mL plasma LLOQ's of small molecule drugs and their metabolites in biological samples. The research goals include demonstrating that multi-dimensional coupled-column techniques where the final 'LC dimension' is a nanoscale HPLC or UPLC column (75 micron i.d.) which is interfaced to a nano electrospray emitter. The fully integrated system must be capable of achieving sub-pg/mL LLOQ's with a wide linear dynamic range and which meet or exceed current regulated bioanalysis acceptance criteria. The selected postdoctoral candidate must demonstrate excellent oral and written communication skills, a passion for applied scientific research, a desire to work hard in a small team environment and a solid background in modern analytical techniques with 'good hands and a good head' for innovation and application of LC/MS and sample preparation techniques. A strong foundation in modern trace quantitative analysis techniques associated with robust and reliable method development and validation via LC/MS techniques are highly desirable. This position requires a PhD in chemistry, biochemistry, or biology or related field; or equivalent combination of education, training and experience.2012-05-15 05:26:54United StatesQuintilesNew York1206764NYIthaca, NY28694884http://quintiles.jobs/xml/28694884/jobUSAResearch Triangle ParkTitle: Data Architect I/II Location: USA-North Carolina-Research Triangle Park Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visitwww.quintiles.com. Apply now for our Data Architect I/II position located in our Research Triangle Park, NC office. Data Architect I/II Incumbent will undertake Enterprise Data Warehousing, Master Data Management and Data Integration initiatives within the Global Data Services Group in support of Quintiles Infosario and other BI/Analytics programs. The ideal candidate will have experience in conceptualizing, designing, developing, and deploying Enterprise-level Data Warehouses, MDM and associated Data Stores, providing technical guidance to other resources, managing projects on a global basis, and have experience in a variety of data warehousing concepts and best practices for master data management, data quality and . The Data Architect will have a strong level of experience in the following: * Development experience with Oracle database technologies * Development and software design using ETL , MDM and SOA toolsets. * Building of Operational Data Stores (ODS), Data Marts, and Enterprise Data Warehouses * Developing Technical Specifications and Architecture Blueprints for Data Warehousing and Analytics/BI infrastructures. * Business and Technical Metadata Management * Data Analysis and Data Model Development (i.e. logical and physical models) * Data Quality Management practices using commercially available tools * Data Governance Concepts and Processes * Enterprise Data Integration across multiple systems with leading EAI and/or ETL tools and OLAP tools * Master Data Management concepts The ideal candidate will be a proponent for innovation, best practices, sound design with data & information optimization in mind, strong development habits, and efficient team/project structures. Quintiles Information Technology offers a world class, global organization with ample career development and opportunity. We are seeking change agents that are highly motivated and enthusiastic to join our talented team! REQUIREMENTS • Highly prefer a 4 year technical degree • Health and Life Sciences experience is desirable. • A minimum of 7 years total relevant experience including experience with enterprise data warehouse design and development AND relevant conceptual, logical, and physical data modeling, both with inmon and Kimball style methodologies. • Relevant technical experience with enterprise master data management and data quality systems design, development and operations. • A conceptual understanding and familiarity with service oriented architectures, application frameworks and system integration methods. • Working knowledge of development and software design on J2EE platforms. • Must possess excellent project management and problem solving skills. • Experience with full lifecycle development projects and agile methodologies. • Familiarity with emerging technologies and SW development best practices, particularly related to enterprise data development, master data management and data quality. • Demonstrated ability to communicate with business leaders, stakeholders and coworkers at all levels within the organization. • Development experience with Oracle database technologies. • Building of operational data stores, data marts and enterprise data warehouses. • Experience with developing technical specifications and architectural blueprints. • Experience with business and technical metadata management. • Experience with Data analysis and data model development. • Experience with data quality management practices. • Experience with data governance concepts and processes. • Experience with enterprise data integration across multiple systems with leading EAI and/or ETL tools and OLAP tools. The ideal candidate will be a proponent for innovation, best practices, sound design with optimization in mind, strong development habits, and efficient team/project structures. We are seeking change agents that are highly motivated and enthusiastic to join our talented team!.2012-05-15 05:26:31United StatesQuintilesNorth Carolina1201730NCResearch Triangle Park, NC28694883http://quintiles.jobs/xml/28694883/jobUSAOverland ParkTitle: Project Manager, Phase I Clinical Research Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. As Phase I Project Manager, your main responsibility will be to manage clinical projects and Trial Master Files and to ensure that all project work is completed in accordance with SOPs, policies and practices. You will monitor and coordinate efforts of cross-functional project teams and meet with team members on a regular basis regarding project tasks to ensure project milestones are met. In addition, you will serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. Additional responsibilities include: * Collect information on team performance against contract, customer expectations, and project baselines * Lead problem solving and resolution efforts * Develop and oversee maintenance of internal databases and project plans * Demonstrate understanding of the full scope of projects and negotiate project budget as required * Produce and distribute reports and presentation materials * May participate in proposal development * Partner with other Project managers to develop and implement process improvements * Prepare and present project information at internal and external meetings * Ensure that work is conducted in compliance with standard processes, policies and procedures and meets quality and timeline metrics REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Strong communication and interpersonal skills * Good problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good teamwork skills * Excellent customer service skills * Good judgment * Ability to work with minimal direction * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with colleagues and team members MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelors degree in life sciences or related field with 5 years clinical research experience and 2 years project management experience; or equivalent combination of education, training and experience * RN preferred2012-05-15 05:26:21United StatesQuintilesKansas1207088KSOverland Park, KS28694881http://quintiles.jobs/xml/28694881/jobUSANoneTitle: Project Director - Rheumatology - US or EU based Location: United States Other Locations: Switzerland, Portugal, Italy, Poland, Spain, Belgium, France, Germany, Ireland, Great Britain Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are recruiting a Project Director to join our Rheumatology TDU on a permanent basis. The purpose of this role is using broad management discretion, to lead complex, global, multi-functional, project(s) or program, including the study management execution of the project/program, to the Sponsor's satisfaction, ensuring all deliverables are met, including quality, time and budget deliverables. You will have strategic decision-making responsibility for the project/program and will ensure that all project work is completed in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage the scope of work, objectives, quality of deliverables, and other project and study management activities. * Serve as primary project/program contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to. * Ensure the development of project plans for all phases of the project lifecycle, including the quality and risk management, ensuring that issue escalation and resolution is clear. * Develop proactive contingency plans to mitigate clinical risk across studies. * Work with Business Development to finalize the project/program budget and scope of work. * Direct and lead project activities for team members related to their project-oriented tasks to ensure that project/program milestones are met. * Continually review and make recommendations to ensure adequate resources are available to meet project deliverables and milestones * Develop, lead and implement continuous improvement for assigned projects and programs. * Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; implement plan following approval by senior management ensuring adherence to change control processes. * Provide consultation to clients on drug development process, study management strategy, and plans as needed. * Participate in proposal and budget development, evaluate feasibility of potential programs and impact on company operations and goals, negotiate and make decisions on behalf of the organization. Participate in sales/proposal presentations in face-to-face meetings with potential clients. * Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes * Demonstrated financial management skills, including project financial tracking and accounting methods * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Excellent communication and interpersonal skills, including good command of English language * Excellent customer management skills * Excellent organization and problem-solving skills * Strong presentation skills * Ability to balance operational and strategic priorities * Proven ability to work through others to deliver results to the appropriate quality and timeline metrics * Strong influencing and negotiation skills * Highly effective team leadership skills * Sound judgment and decision making skills * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 12 years clinical research experience including 8 years project management/ leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience2012-05-15 05:26:14United StatesQuintilesNone1207229NoneVirtual, USA28694880http://quintiles.jobs/xml/28694880/jobUSAOverland ParkTitle: Service Desk Technician 1 Location: USA-Kansas-Overland Park Other Locations: Come see why Quintiles has just been named toComputerworld's2008 list of the "100 Best Places to Work in IT" . A career at Quintiles Transnational Corp. puts you at the corporate center of the leading worldwide pharmaceutical services organization. If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. Apply now for our Service Desk Technician I/II position in our Overland Park office. NOTE: THIS IS AN OVERNIGHT SHIFT - SELECTED CANDIDATE MUST BE WILLING TO WORK NIGHTS. · Provide first level support to end users regarding IT problems and service requests heavily utilizing remote control tools. Expectation that 70% of incidents will be resolved on the first interaction with the customer. · Adhere to established IT policies, procedures and standards and ensures their conformance with information systems goals and procedures. · Provide management with information on problems that are severe in nature, recruiting, or that are exceeding target dates. · Maintain currency in new developments and technology. · Provide training as needed to end-users. · Ensure that security procedures are implemented and enforced. · Follow problem management procedures including the logging of all calls into the Problem Management System. · Interaction with IT management frequently through timely reporting of operational activities. Frequent interaction with customers on support issues and needs assessments. · Maintain a thorough working knowledge of the day-to-day operating environment, available tools, and client applications. Maintain a working knowledge of Service Desk and IT Operations procedures related to client services. · Provide assistance in the areas of site support, and project specific assignments. Will perform duties on local and regional levels. · Participation on global and regional project teams. · Providing support for business applications. · Perform other duties as required. · Working knowledge of Microsoft server, networking, and workstation technologies. · Working knowledge of industry standards in regards to system and network administration · Ability to solve PC related problems utilizing remote control tools · Ability to analyze data points from monitoring and reporting tools to identify root cause of problems and perform the necessary functions or assignments to other teams to resolve the problem. · Excellent verbal and written communication skills · Willingness to improve in personal knowledge as it applies to supporting the company's objectives · Project management exposure · Strong analytical and trouble shooting skills · Willingness to improve in personal knowledge as it applies to supporting the company's objectives MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Associates Degree in Computer Science or related field or at least two years coursework completed towards Bachelor's Degree in Computer Science or related field · 2 years in Information Technology with emphasis in PC software (Microsoft operating systems and applications suites, email systems, etc.) within a network environment utilizing PC/server software; or equivalent combination of education, training and experience. · ITIL certification preferred PHYSICAL REQUIREMENTS · Extensive use of telephone and face-to-face communication requiring accurate perception of speech · Extensive use of keyboard requiring repetitive motion of fingers · Regular sitting for extended periods of time · Occasional travel may be required · Ability to bend, stoop, crawl and lift up to 60 pounds · After-hours (weekday and weekend) work to cover specific shifts2012-05-15 05:26:12United StatesQuintilesKansas1207012KSOverland Park, KS28694879http://quintiles.jobs/xml/28694879/jobUSAOverland ParkTitle: Medical Writer, Pharmaceutical Research Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Medical Writer 1 provides medical writing support and assists senior staff in the preparation and review of study reports, submissions, and other documents for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Participates in project teams and may serve as a writing lead for specific tasks or project. Specific responsibilities include: * Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review. * Participates in both internal and external project team meetings and liaises directly with the customer on medical/technical writing issues, as appropriate and with senior support as needed. * Facilitates appropriate internal review of assigned documents and takes responsibility for on-time delivery. * May perform QC review of documents or parts of documents prepared by more senior staff. * Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, * Complies with Company SOPs and participates in the implementation of new SOPs. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. * Familiarity with the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients. * Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. * Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance. * Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results. * Ability to give a simple presentation to a project team and/or customer, e.g. on medical/technical writing processes. * Ability to identify inconsistencies and deficiencies in statistical output as related to acceptance criteria according to SOPs. * Ability to work on several projects at once while balancing multiple and overlapping timelines. * Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW). * Careful attention to detail and accuracy. * Must be computer literate. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in a life science-related discipline, or communications, technical writing, or related field with at least 1.5 years of experience in a medical, clinical, preclinical, chemistry or related environment; or equivalent combination of education, training and experience.2012-05-15 05:26:05United StatesQuintilesKansas1207007KSOverland Park, KS28694877http://quintiles.jobs/xml/28694877/jobUSANoneTitle: Clinical Project Coordinator (Late Phase) Location: United States Other Locations: **This position is located in Raleigh/Durham, North Carolina** PURPOSE Provide project related assistance for assigned project(s) and project teams with guidance. Will ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. RESPONSIBILITIES ?Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPS. ? Assist with periodic review/audit of files for accuracy and completeness. ? Assist with the coordination and tracking of all information, communications, documents, materials and supplies for assigned projects. ? Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly. ? Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. ? Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices. ? Support the preparation of presentation materials for meetings (internal/external) and project summary data. ? Support the coordination of project team and/or customer meetings including logistics and materials required REQUIRED KNOWLEDGE, SKILLS AND ABILITIES ?Good team work skills ? Problem solving skills ? Results and detail-oriented approach to work delivery and output ? Ability to prioritize own workloads to meet deadlines ? Strong software and computer skills, including MS Office applications ? Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE ?High School Diploma and 4 years' relevant experience; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS ?Extensive use of keyboard requiring repetitive motion of fingers. ? Extensive use of telephone and face-to-face communication requiring accurate perception of speech. ? Regular sitting for extended periods of time. ? May require limited travel.2012-05-12 04:22:30United StatesQuintilesNone1206802NoneVirtual, USA28655215http://quintiles.jobs/xml/28655215/jobUSADes MoinesTitle: Pharmaceutical Sales Representative - Des Moines, IA 6531 Location: USA-Iowa-Des Moines Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representativeto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting Purdue Pharma L.P., an industry leader committed to improving patient's lives and serving the healthcare community. Pharmaceutical Sales Representative The Sales Representative will target, promote and sell our partner's therapeutic products to general practitioners and other healthcare providers as directed. The Sales Representative manages an assigned territory in order to grow our customer's business among a targeted physician audience and further develop relationships with new physician groups to achieve customer objectives. The Sales Representative will also be responsible for providing quality consultative services, coordinating and integrating outside alliances and providing resources to fit customer needs. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required · A minimum overall undergraduate college GPA of 2.8/4.0 · A minimum of 1.5 years of pharmaceutical sales experience · A documented track record of success · Ability to demonstrate proven sales performance over time · Must reside within the territory in an appropriate location to efficiently work the territory · Strong work ethic and customer focus orientation · Excellent communication and organization skills · Have a valid operator's license and be insurable. Preferred Skill Set: · Have interest, desire and ability for upward career growth · Have 2-4 years of successful Pharmaceutical experience · Have experience in the insomnia market · Have documented success launching a new product Competencies · Demonstrated analytical skills · Demonstrated Business Acumen · Demonstrated success in persuasion, influence and negotiation skills · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Knowledge of and experience with the selling process · Initiative & execution-oriented · Teamwork2012-05-12 04:22:29United StatesQuintilesIowa1207155IADes Moines, IA28655214http://quintiles.jobs/xml/28655214/jobUSALas VegasTitle: Clinical Research Associate / CRA / Sr CRA / Nevada ~ Location: USA-Nevada-Las Vegas Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-05-12 04:22:26United StatesQuintilesNevada1207164NVLas Vegas, NV28655213http://quintiles.jobs/xml/28655213/jobUSAAltoonaTitle: Cardiology Specialty Sales Representative - Altoona, PA 6594 Location: USA-Pennsylvania Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-12 04:22:25United StatesQuintilesPennsylvania1207161PAAltoona, PA28655212http://quintiles.jobs/xml/28655212/jobUSAKalamazooTitle: Pharmaceutical Sales Rep - Eye and Ear Kalamazoo, MI 6175 Location: USA-Michigan-Kalamazoo Other Locations: We are excited to announce that at this time we are looking for Sales Representatives to join our team of over 7,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting the largest specialty eye care company in the world and have the opportunity to become part of their team at the end of contract. Sales Representative - Eye and Ear The Sales Representative targets, promotes and calls primarily on Pediatricians and Otolaryngologists as well as some Primary Care Physicians, General Practitioners and Family Practitioners. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. Conduct face-to-face presentations with physicians to educate them on both current and future products. The Specialty Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including competitive compensation and bonus structure, car allowance, medical, dental, life insurance and vision coverage, tuition assistance and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com Be sure to reference job code 6175. EOE • 4 year degree required • 1 year of Business to Business sales experience a plus or recent college graduate with demonstrated leadership in community, professional and/or college organizations • Strong work ethic and customer focus orientation • Excellent communication and organization skills Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-05-12 04:22:23United StatesQuintilesMichigan1207173MIKalamazoo, MI28655211http://quintiles.jobs/xml/28655211/jobUSABostonTitle: Associate Business Development Director, Bioanalytical Services Location: USA-Massachusetts-Boston Other Locations: PURPOSE Prospect for new opportunities, secure and retain bioanalytical/DMPK business through professional, consultative, proactive sales activities directed at decision-makers and decisionnfluencers at existing and new sponsors. RESPONSIBILITIES • Actively prospect and leverage potential new business opportunities within specified customer account(s). • Cultivate strong, long-term relationships with key decision-makers within Account and develop in-depth knowledge of the customer organization. • Maintain general knowledge of all Quintiles services for appropriate cross-sell opportunities. • Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards. • Identify and respond to customer needs in order to define potential opportunities. Propose appropriate strategy/solution to customer. • Prepare proposals and coordinate with contracts to submit/follow up on proposals. • Work with operations, marketing and BD team to prepare marketing collateral, and give sales presentations Educate colleagues in customer culture, operational needs/methods and sales techniques needed to close the sale. • Handle follow-up related to the sale and drive completion of contractual documents. • Adapt successful strategies and tactics to meet market demands and financial targets. • Maintain high visibility within customer organization. Monitor customer satisfaction by communicating regularly with customer. • Establish and execute a comprehensive sales plan for each target account. Analyze potential opportunities and ensure appropriate strategy/solution is proposed to customer. Monitor actions and results against plans. • Monitor actions and results against plans. • Record all customer sales related activities in tracking system. • Prepare sales activity report for Sales Management as required. • Serve as a liaison between the customer and technical and operational groups at Advion All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Proven track record at mid-level and high-level contacts • Strong organizational, planning, project management skills • A developing record of customer contacts at the outsourcing, procurement and mid - management level • Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business • Excellent analytical skills in assessing and interpreting customer business data • Ability to maintain demanding timelines • Ability to influence others internally and externally • Adaptability and flexibility to changing priorities • Demonstrated ability to work creatively in a fast-paced environment • Exceptional attention to detail and ability to work simultaneously on multiple priorities • Ability to work independently and as a team player • Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel • Excellent oral and written communication skills • Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree in Science (chemistry, biochemistry, biology, animal science) and 10 years related experience, including 3 years of relevant industry laboratory or outsourcing experience (CRO/Pharmaceutical) and/or bioanalytical/DMPK sales experience; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS • Use of keyboard requiring repetitive motion of fingers • Extensive use of telephone and face-to-face communication requiring accurate perception of speech • Frequent travel • Frequent long, varied hours2012-05-11 05:07:45United StatesQuintilesMassachusetts1207107MABoston, MA28628143http://quintiles.jobs/xml/28628143/jobUSACambridgeTitle: Principal CRA Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. preferred location is Outcome headquarters in Cambridge, MA but will consider home based location. Purpose: The Principal CRA at Outcome participates in the planning, design and execution of post marketing approval registry studies to ensure all studies are conducted according to the intent of the client/sponsor while adhering to regulatory guidelines, SOPs, GCP (where applicable) and registry protocols while working collaboratively with internal and external project team members with the ability to manage complex/international studies. Has the ability to independently perform on-site monitoring visits in addition to supporting co-monitoring visits. Remotely supports physicians, nurses, pharmacists, research coordinators and other healthcare workers in use of the company's internet-based tools (EDC) and in all aspects of post-marketing registry management through phone and email support. Provides in-house support to contract CRAs, and mentors CRA Is and Clinical Research Assistants. Proactively identifies and escalates or resolves operational project issues and participates in process improvement initiatives as required. Primary Responsibilities: * Lead study start-up activities (i.e., site recruitment, regulatory document collection, IRB submission) including the review of clinical and project-related documents (i.e. protocol, case report form, Informed Consent, monitoring plan, site recruitment plan, source documents, training manuals, study binders, patient contact material, etc.)Act as site liaison to CRAs/Project Managers * Serve as a clinical resource for sites, Project Managers, Clinical Data Managers, contract Clinical Research Associates, and other Outcome staff for project-related inquiries and issues; conduct initial and ongoing site, sponsor, and project staff training as necessary * Participate regularly in client calls; provide updates on study reports (site, enrollment, regulatory document, query, monitoring status, etc.); assist the client in problem solving and provide consultation on study-related activities where applicable * Manage and track study progress on recruitment/site selection, site readiness, IRB/EC submissions, patient enrollment, etc. * Utilize internal databases to manage and track site/client contacts, patient enrollment, and other registry-specific reports, and provide reports to Project Management/CRAs/client in a timely manner * Ability to understand and contribute to EDC and PCMS specifications, database requirements, customizations, queries/form controls * Perform comprehensive trainings on the protocol and the company's EDC for sites (web-based), clients and internally to the team * Primary contact for all site interactions (phone and email support) involving the company's EDC by addressing clinical and protocol-related questions * Maintain correspondence with sites to ensure compliance with study procedures, assess patient accrual, applicable regulations and ICH/GCP (if applicable), and has the ability to recognize and escalate issues where appropriate * Investigate, track, prioritize, and resolve site/client user feedback, complaints and issues. Has the ability to recognize and escalate issues where appropriate and choose appropriate method of communication * Ability to prepare appropriate, timely and accurate communication to internal and external registry teams, consultants and investigative site personnel * Mentor and train less experienced Clinical Study Assistants and less experienced Clinical Research Associates * Participate in remote monitoring and data quality audits * May be required to conduct independent on-site visits (Qualification, Initiation, Interim, Close-Out) to monitor study progress and assure compliance with protocol-requirements, applicable regulations and ICH/GCP (if applicable), ensures Investigator Site File is up to date; assist site with IRB/EC submissions; generate monitoring visit reports, confirmation and follow-up letters; identify and solve or escalate problems/issues where appropriate * May function as Lead CRA; possess the ability to oversee, train, and coordinate contract CRAs and junior level staff worldwide as appropriate; including review of monitoring reports and tracking monitoring activities * May perform other duties as applicable * May participate in site contract negotiation and budgeting within approved parameters * May include participation in financial budget management , bid defense meetings, and formulating strategic solutions to ensure study success (i.e., contingency plans, recruitment strategies, patient retention strategies, site/patient incentives, collaborate/interact with KOLs) * May include 5 - 25% travel, to attend Investigator Meetings, Site Visits, and Professional Conferences Requirements: * Bachelors Degree, preferably in a health or life science concentration * At least 3 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a preferred minimum of 2 years of independent clinical monitoring * Must be detail oriented, enthusiastic, eager, and have a strong customer service sensibility * Excellent time management and decision making skills * Ability to handle multiple tasks and work on multiple project teams simultaneously * Strong organizational skills and self-motivated with the ability to work independently or as part of a team * Ability to take initiative * Excellent verbal, written communication and interpersonal skills * Must be proficient in Microsoft Office * Must have professional demeanor * Experience with Electronic Data Capture (EDC) preferred * Understanding of GCPs and knowledge of regulatory requirements * Willingness and flexibility to travel; this position may require national and/or international travel on a need by basis2012-05-11 05:07:17United StatesQuintilesMassachusetts1207086MACambridge, MA28628142http://quintiles.jobs/xml/28628142/jobUSACambridgeTitle: Research Associate Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: Provide strategic input into observational research on the natural history of disease and comparative safety and effectiveness, to propose methodologically sound study design and analysis plans to meet project objectives and regulatory requirements, and to contribute to analyses, evaluation and reporting. Primary Responsibilities: * Organize and help manage research projects, including development of study design and data collection methods, arrangement and attendance of project meetings, and travel to client sites as needed * Work closely with senior members of Scientific Affairs in writing research proposals, concepts, protocols and study reports, and in executing, analyzing and interpreting observational data * Review data and documents for content and quality * Perform and summarize critical literature reviews * Prepare abstracts, manuscripts and oral presentations, including development of slides and posters for presentation of project results at regional and national meetings * Bachelors Degree required, Masters Degree in public health, epidemiology or a relevant scientific field desirable * Two or more years in healthcare or biopharmaceutical industry with experience coordinating research preferred, equivalent work experience may be considered * Strong quantitative analysis skills required * Strong written and verbal communication skills (medical writing experience a plus) * Exceptional attention to detail and the ability to prioritize and effectively manage multiple tasks * Excellent technical, analytical, computer, organizational, and problem-solving skills * Ability to work independently, both under supervision and as a contributing team member * Microsoft Office including PowerPoint and Excel required; knowledge of SAS required2012-05-11 05:07:17United StatesQuintilesMassachusetts1207108MACambridge, MA28628140http://quintiles.jobs/xml/28628140/jobUSAPortlandTitle: Pharmaceutical Sales Rep - Eye/Ear Portland, OR 6175 Location: USA-Oregon-Portland Other Locations: We are excited to announce that at this time we are looking for Sales Representatives to join our team of over 7,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting the largest specialty eye care company in the world and have the opportunity to become part of their team at the end of contract. Sales Representative - Eye and Ear The Sales Representative targets, promotes and calls primarily on Pediatricians and Otolaryngologists as well as some Primary Care Physicians, General Practitioners and Family Practitioners. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. Conduct face-to-face presentations with physicians to educate them on both current and future products. The Specialty Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including competitive compensation and bonus structure, car allowance, medical, dental, life insurance and vision coverage, tuition assistance and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com Be sure to reference job code 6175. EOE • 4 year degree required • 1 year of Business to Business sales experience a plus or recent college graduate with demonstrated leadership in community, professional and/or college organizations • Strong work ethic and customer focus orientation • Excellent communication and organization skills Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-05-11 05:07:17United StatesQuintilesOregon1207116ORPortland, OR28628141http://quintiles.jobs/xml/28628141/jobUSABostonTitle: Entry Level Clinical Research Associate / CRA / Northeast Region ~ Location: USA-Massachusetts-Boston Other Locations: USA-Connecticut-Waterbury, USA-New York-New York City, USA-Connecticut-New Britain, USA-Pennsylvania, USA-New York-Albany, USA-Connecticut-Norwich, USA-Rhode Island, USA-Connecticut-Danbury, USA-Connecticut-Meriden, USA-Connecticut, USA-Pennsylvania-Philadelphia, USA-Pennsylvania-Pittsburgh, USA-Rhode Island-Providence, USA-Connecticut-Hartford, USA-Connecticut-Stamford Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. This entry level CRA role can be home-based anywhere in the Northeast Region. * BS/BA Degree highly preferred. * At least 3 years of clinical research coordinator experience. * Minimum of 1 year experience working with cardio and/or arthritis studies preferred. * Customer service orientation. * Sound knowledge of medical terminology and clinical monitoring process. * In depth therapeutic and protocol knowledge as provided in company training. * Ability to perform regionalized, overnighttravel an average of 65%, depending on project needs. * Excellent verbal and written communications skills. * Excellent interpersonal and organizational skills and attention to detail. * Computer literacy, proficiency in MS Office.2012-05-11 05:07:15United StatesQuintilesMassachusetts1207126MABoston, MA28628139http://quintiles.jobs/xml/28628139/jobUSABaton RougeTitle: Cardiovascular Care Specialist - Baton Rouge, LA 7069 Location: USA-Louisiana-Baton Rouge Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Specialty Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Specifications for Cardiovascular Care Cardiology/Endocrinology Specialist: * Professionalism and ethics are a must; as a Cardiovascular Care Specialist you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Cardiovascular Care Specialist, you will be making selling presentations to physicians and other health care professionals, in an office based, Cath lab or hospital setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Specialists are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Specialist maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Specialists participate in and are required to complete initial and ongoing product and development training. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience * 4 year Bachelor's degree from an accredited University required * 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * 18 months prior experience promoting cardiology products to Cardiologists and Endocrinologists is preferred. * Strong scientific/clinical acumen required * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-11 05:07:15United StatesQuintilesLouisiana1207128LABaton Rouge, LA28628137http://quintiles.jobs/xml/28628137/jobUSANashvilleTitle: Part-Time Primary Care Sales Representative - Nashville North, TN 7069 Location: USA-Tennessee-Nashville Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Part-time Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. * In this part-time role you would work 3full days on with balance of the week off, followed by 2 full days on with the rest of the week off, the cycle repeats itself. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Residence within the current geography is required. Competencies KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-11 05:07:15United StatesQuintilesTennessee1207129TNNashville, TN28628138http://quintiles.jobs/xml/28628138/jobUSAResearch Triangle ParkTitle: (ITLS) Drug Safety IT Business Analyst (Sr BA or Lead BA) Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta Quintiles Information Technology Unit is completing the implementation of a global adverse event processing and analysis platform. This platform has been designed to support operations and services for more than 50 clients worldwide with access by several hundred lifecycle safety associates and management located on 4 continents. As adoption of the platform increases, our Global IT team will expand to support platform enhancements, operations for internal Quintiles resources, as well as, many collaboration partners accessing the platform from outside. We are seeking people with experience in technical areas along with knowledge of drug safety solutions and process to join our team. PURPOSE We are seeking top Business Analysis candidates. The Business Analyst will be working on initiatives that assist in the implementation and management of a Lifecycle Safety Platform. Candidate should have in depth experience completing business/functional requirements with experience of Use Cases and Agile methodologies being highly desirable. Must be a strategic thinker, results driven, detailed orientated and capable/comfortable of assuming responsibility for analysis assignments in order to work with minimal supervision. This candidate should have experience working with formal development methodologies, be knowledgeable of various business analysis techniques and have experience maintaining requirements following a formal change control process. Will work closely with stakeholders to develop Use Cases and write Business and Functional Specifications through use of formal development methodologies. Candidate also will work closely with the BA lead to facilitate progress of assigned project work. Must have an understanding of current requirements elicitation, analysis, specification, and verification, and the ability to apply them in practice. Will guide users in identifying business requirements by using various business analysis elicitation/analysis techniques to determine the needs of the business. Will effectively lead group discussions, eliciting requirements from geographically dispersed stakeholders and communicating both technical concepts to non-technical audiences, and business concepts to technical audiences. Will analyze the abilities of tools and technologies, compare with the need of the business, then recommend potential solutions to stakeholders Including new, improved processes for increased effectiveness and efficiency. Will collaborate with developers to ensure adherence to business requirements and UI design specifications. May assist with prototyping/mock ups - ( Irise experience advantageous). Will be expected to coach/mentor junior staff, provide technical leadership and develop training and support programs for global technology and process implementations as needed. Will develop training and support programs for global technology and process implementations, as needed. Candidate will be expected to maintain knowledge in IT and Drug Safety. To be successful, candidate should have the following skills: - strong technical and business writing skills - strong knowledge of technical and grammatical editing - strong knowledge of Use Case and User Story development - strong knowledge of best practices for user interface design - an understanding of graphical design and prototyping tools - strong communication, organizational, prioritization and leadership skills- detailed orientation with strong analytical aptitude - an understanding of Business Process modeling. REQUIREMENTS - A Bachelor's degree, and have a minimum of 5 years of business analysis experience (eliciting, analyzing, documenting and managing requirements for IT systems) - A minimum of 5 years experience in utilizing formal development methodologies - A minimum of three years experience with various business analysis elicitation/analysis techniques - A minimum of three years experience in writing Business and Functional Specifications - A minimum of two years of Pharma experience - A minimum of two years experience in a drug safety and pharmacovigilance software platform such as Argus, ArisG, or similar - A minimum of two years experience in Workshop facilitation experience - Must be able to travel up to 15% Additional Recommended Attributes: - Experience with a requirements management Tool (Top Team experience advantageous)2012-05-11 05:07:13United StatesQuintilesNorth Carolina1207134NCResearch Triangle Park, NC28628135http://quintiles.jobs/xml/28628135/jobUSAResearch Triangle ParkTitle: Sr Medical Writer / Medical Writer 2 Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Kansas-Overland Park, USA-Maryland-Rockville Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23000 engaged professionals, in more than 50 countries around the world, works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies to navigate risk and seize opportunities in an environment where change is constant. PURPOSE Take a leading role in preparing or contributing to the production of most types of clinical documents, method validation and study data reports, site manuals, or posters for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Acts as mentor for less experienced Medical Writers and assists in their training and development. Participates in project teams. RESPONSIBILITIES * Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical and/or technical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience. * Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed. * May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development. * May present on standard medical and/or technical writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on medical/technical writing to other Quintiles groups. * May act as Project Manager for a small stand-alone medical and/or technical writing project (e.g. protocol or CSR). May coordinate medical and/or technical writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking. * Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing. * May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs. * Bachelor's degree in a life science-related discipline, communications, technical writing, or related field, with at least 2.5 - 5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and/or method validation and study data reports; or equivalent combination of education, training and experience. * Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally. * In-depth knowledge of the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients. * Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner. * Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance. * Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results. * Understanding of the time needed to perform routine medical and/or technical writing tasks in order to agree on appropriate timelines and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions. * Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority. * Ability to identify deficiencies, errors, and inconsistencies in a protocol or report. * Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output as related to acceptance criteria according to SOPs. * Developing skills in providing effective and sensitive written and verbal feedback to junior staff, and to customers when appropriate. * Confident and effective communication and negotiation skills with customers and project managers. * Developing skills in chairing small meetings. * Ability to work on several projects at once while balancing multiple and overlapping timelines. * Ability to assess and prioritize workload. * Demonstrated abilities in collaboration with others and independent thought. * Knowledge of regulations relevant to medical/technical writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g., OECD, MHLW). * Careful attention to detail and accuracy. * Must be computer literate. * Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-05-11 05:07:01United StatesQuintilesNorth Carolina1207006NCResearch Triangle Park, NC28628134http://quintiles.jobs/xml/28628134/jobUSAResearch Triangle ParkTitle: Director, HR Service Delivery - Clinical Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 25,000 engaged professionals in over 60 countries are committed to making people healthier. The work we do in every therapeutic discipline makes a difference in the lives of patients everywhere. For example, Quintiles has helped develop or commercialize 100% of all Diabetes products approved between 2004 and 2010. In fact, Quintiles has helped speed to market all 30 of the world's top 30 best-selling drugs. Join us as we define TheNewHealth. PURPOSE Provide support for continuous improvement of the HR function through development and implementation for all HR programs in an assigned geography or business line. As HR Business Partner, with limited guidance, provide expertise, support and advice to assigned management teams for North America Clinical Development Services. With senior management, establish strategic goals and priorities and direct/oversee their delivery. Lead a team of HR professionals, in a direct line or matrix structure, to assure business delivery and results. RESPONSIBILITIES · Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. · Develop strong and effective team relationships with HR specialist functions/Centers of Excellence, e.g., HRPSC, Finance PSC. · Develop, manage and oversee the functional HR budget and manage expenses within budget allocations. · Lead implementaton of projects and process improvement acitivities related to employment legislation, HR systems, practices, procedures and compliance. · Lead implementation of projects and process improvement activities for the day-to-day development of redesign and new local and global HR initiatives. · Provide HR Partnering management coaching and counseling to business leaders and managers to effectively meet business line/region goals. · Act as Business Partner to assigned business areas and ensure that HR delivery adds value to the business. · Lead and direct activities and initiatives associated with change management involving reorganizations, mergers/acquisitions and transfers to ensure compliance to local legislation. · Ensure the provision of timely employee-related information to management teams as necessary. · Provide advice, guidance and direct support on all aspects related to people management to senior management. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Experience establishing and leading HR service delivery across large, matrixed, multi-location organizations · Sound knowledge of local and relevant employment legislation · Strong knowledge of CRO or pharmaceutical and other related business industries · Excellent problem solving, judgment and decision making skills · Excellent presentation skills · Expert coaching and counseling skills · Good computer skills, including Microsoft Office applications and HRIS applications · Highly persuasive influencing skills · Organization and project management skills · Excellent leadership skills · Strong verbal and written communication skills and very good interpersonal skills · Very high degree of discretion and confidentiality · Good attention to detail · Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree or educational equivalent and 8 years experience as a generalist or combination of generalist and specialist experience including 3 years direct line management experience and experience operating with senior/executive management teams; or equivalent combination of education, training and experience · Professional HR accreditation2012-05-10 04:34:08United StatesQuintilesNorth Carolina1207058NCResearch Triangle Park, NC28597775http://quintiles.jobs/xml/28597775/jobUSAResearch Triangle ParkTitle: HR Service Delivery Manager Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta, USA-Kansas-Overland Park Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 25,000 engaged professionals in over 60 countries are committed to making people healthier. The work we do in every therapeutic discipline makes a difference in the lives of patients everywhere. For example, Quintiles has helped develop or commercialize 100% of all Diabetes products approved between 2004 and 2010. In fact, Quintiles has helped speed to market all 30 of the world's top 30 best-selling drugs. Join us as we define TheNewHealth. PURPOSE Provide support and guidance to less experienced members of the HR team in their day-to-day operational roles. Support the continuous improvement of the HR function through development and implementation of HR programs in an assigned geography or business line. With limited guidance, provide comprehensive HR support to employees and management across assigned service areas, business units, or departments. As HR Business Partner, with guidance, provide expertise, support and advice to assigned management teams either locally and regionally. RESPONSIBILITIES · Develop strong and effective team relationships with HR specialist functions/Centers of Excellence, e.g., HRPSC, Finance PSC. · Maintain and develop local HR policies regarding employment legislation, HR systems, practices, procedures and compliance as required to ensure risk of litigation is mitigated and staff, company and customer interests are maintained. · Provide advice and guidance to more junior members of the HR team as appropriate. · Lead specific projects and support the day-to-day development and implementation of redesign and new local and global HR initiatives. · Provide HR Partnering management coaching and counseling. · Act as Business Partner to assigned business areas and ensure that HR delivery adds value to the business. · Provide input and assist in or lead efforts associated with change management efforts involving reorganizations, mergers/acquisitions and transfers to ensure compliance to local legislation. · Provide reports and analyses as requested by senior management. · Support line managers in the recruitment and selection process where appropriate. · Provide advice and guidance on all aspects related to people management, absenteeism, workforce planning, talent development and management, etc. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Experience supporting Business Development/Sales or Data Management functions desired. · Sound knowledge of local and relevant employment legislation · Expert coaching and counseling skills · Excellent problem-solving with sound judgment and decision-making skills · Excellent presentation skills · Effective leadership skills · Experience working in a highly matrixed, multi-location environment · Good computer skills, including Microsoft Office applications and HRIS applications · Organization and project management skills in leading a project · Effective influencing skills · Strong verbal and written communication skills and very good interpersonal skills · Very high degree of discretion and confidentiality · Good attention to detail · Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree or educational equivalent and 5 years experience within an HR function as a generalist or combination of generalist and specialist experience including experience operating with senior/ executive management teams; or equivalent combination of education, training and experience · Professional HR accreditation2012-05-10 04:34:06United StatesQuintilesNorth Carolina1207066NCResearch Triangle Park, NC28597773http://quintiles.jobs/xml/28597773/jobUSACambridgeTitle: Service Desk Techn 2 - Outcome/Cambridge MA Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: Provide technical support for the Outcome software application. This includes all aspects of site management - training, ongoing support, and monitoring of customer satisfaction. Performing comprehensive, articulate trainings and resolving customer support issues are two key components of the position. Primary Responsibilities: · Conduct initial and ongoing site, sponsor, and project staff training as necessary via teleconference · Serve as primary contact for all site interactions and as liaison between users and Project Managers, escalating issues as appropriate · Solicit, track, analyze, prioritize, escalate (as needed) and resolve user feedback, complaints, and issues · Assist the client/users in problem solving and provide consultation on study related activities · Serve as a technical support for sites, Project Managers, Data Managers, contract Clinical Research Associates/Monitors, and other Quintiles Outcome staff for project-related inquiries and issues · Develop customer-facing documentation for the software application on an as-needed basis · Perform project related administrative tasks as needed Requirements: · Bachelor's degree, preferably in a Computer Science , Engineering or other related field · Ability to learn quickly, multi-task and prioritize · Must be detail oriented, enthusiastic, self-motivated, eager, and have a strong customer service sensibility · Excellent communication and interpersonal skills · Highly organized and self motivated with the ability to work independently · Must be proficient in Word, Excel, Powerpoint and Internet Explorer FLSA Category:Exempt2012-05-09 04:55:04United StatesQuintilesMassachusetts1206775MACambridge, MA28567762http://quintiles.jobs/xml/28567762/jobUSACambridgeTitle: Service Desk Techn 2 - Outcome/Cambridge MA Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: Provide technical support for the Outcome software application. This includes all aspects of site management - training, ongoing support, and monitoring of customer satisfaction. Performing comprehensive, articulate trainings and resolving customer support issues are two key components of the position. Primary Responsibilities: · Conduct initial and ongoing site, sponsor, and project staff training as necessary via teleconference · Serve as primary contact for all site interactions and as liaison between users and Project Managers, escalating issues as appropriate · Solicit, track, analyze, prioritize, escalate (as needed) and resolve user feedback, complaints, and issues · Assist the client/users in problem solving and provide consultation on study related activities · Serve as a technical support for sites, Project Managers, Data Managers, contract Clinical Research Associates/Monitors, and other Quintiles Outcome staff for project-related inquiries and issues · Develop customer-facing documentation for the software application on an as-needed basis · Perform project related administrative tasks as needed Requirements: · Bachelor's degree, preferably in a Computer Science , Engineering or other related field · Ability to learn quickly, multi-task and prioritize · Must be detail oriented, enthusiastic, self-motivated, eager, and have a strong customer service sensibility · Excellent communication and interpersonal skills · Highly organized and self motivated with the ability to work independently · Must be proficient in Word, Excel, Powerpoint and Internet Explorer FLSA Category:Exempt2012-05-09 04:55:03United StatesQuintilesMassachusetts1206774MACambridge, MA28567761http://quintiles.jobs/xml/28567761/jobUSAResearch Triangle ParkTitle: Sr. Director, Global Operations (North East) Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE The purpose of the role is toserve as a Global Operations Head (GOH), leadingthe development of the assigned client book of business- in volume and indeed in additional innovative strategic resourcing models. Using broad management discretion, direct, supervise and manage complex, multi-regional, books of business to the Sponsor and Quintiles satisfaction, ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with SOPs, policies and practices. Key responsibilities: · Oversee project and program delivery for all assigned key customer contracted work across Global Product Development, ensuring metrics and customer goals are achieved, consolidating resources, sharing best practices, achieving customer loyalty and program risk management for the portfolio of work. · Serve as a senior operations customer-facing linkage between Quintiles and customer's organization, developing relationships within customer development group and liaising with other customer functional groups as applicable to enhance the value of the partnership. · Establish and lead activities related to the Executive and Operational Governance bodies and be directly responsible for resolution of issue escalation, both internally and externally. · Manage strategic initiatives between the organizations that will increase value to the partnership. · Lead the development of the customer Strategic Account Management (SAM) objectives and oversight for customer strategy map and process optimization initiatives. Find and create opportunities to advance the partnership. · Support Sales, Consulting, Capital and other divisions to develop opportunities that create value for the partnership. · Implement Quintiles' corporate initiatives specific to the key customer, collect and share best practice, quality risk management and manage the tracking, review and reporting on systems. · Virtually lead and mentor local and global functions e.g. Quality Assurance, Data Management, Lifecycle Safety to support, deliver, and enable peer relationships and enhanced opportunities to grow the partnership. · Responsible for the identification of operational efficiencies in our work with the assigned key customer and then the implementation of efficiencies to further enhance the partnership. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES ?Excellent communication and interpersonal skills. ? Good problem solving skills. ? Demonstrated ability to deliver results to the appropriate quality and timeline metrics. ? Strong influencing and negotiation skills. ? Good matrix team leadership skills. ? Excellent customer service skills. ? Sound judgment and decision making skills. ? Strong software and computer skills, including MS Office applications. ? Strong financial analysis skills; preferably thorough understanding of company margins, pricing strategies, and profitability measures. ? Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in Life Science, Business Management or related field and a minimum of 15 years in the pharmaceutical, CRO, or related industry and experience to include clinical operations, CRA, Commercial and /or alternative operational functional (e.g. business development, data management, project management, laboratory, pre-clinical); or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS ?Extensive use of keyboard requiring repetitive motion of fingers. ? Extensive use of telephone and face-to-face communication requiring accurate perception of speech. ? Regular sitting for extended periods of time. ? Global travel 25% of time.2012-05-09 04:54:52United StatesQuintilesNorth Carolina1206931NCResearch Triangle Park, NC28567760http://quintiles.jobs/xml/28567760/jobUSACambridgeTitle: Site Support Engineer 2 - Outcome, Cambridge MA Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: Provide remote Level 2 technical support for all Outcome software application users, including restoring service and/or identifying and correcting core problems.Works with the Technical Support Manager and the Project Management team to resolve escalated client and user issues. Primary Responsibilities: · Assist customers with technical issues with the Outcome software applications · Recreate user problems to resolve operating difficulties and recommend system modifications to reduce user problems · Answer questions from customers and prospective customers about the features and capabilities of the software applications · Serve as a first point of escalation from Technical Support Representatives for any software issues and concerns, keeping Technical Support Manager and Project Manager informed of overall customer satisfaction status. · Perform project related administrative tasks as needed · Solicit, track, analyze, prioritize, escalate (as needed) and resolve user feedback, complaints, and issues · Use experience and expertise in customer service, Outcome software application, and troubleshooting skills to identify and implement improvements in processes, procedures, and platform functionality · Participate in internal and external project team meetings, as needed · Delegate support tasks, provide training and advice to more junior team members · Ensure communication of all project-specific information to Technical Support Team in a timely manner Work is done primarily via email and phone contact. Requirements: · Bachelor's degree in Computer Science, Engineering or other related field · 3 years of troubleshooting experience · Ability to learn quickly, multi-task and prioritize · Must be detail oriented, enthusiastic, self-motivated, eager, and have a strong customer service sensibility · Highly organized and self-motivated with the ability to work independently · Excellent understanding of the technicalfundamentals of the Internet. You should have a solid knowledge of internet protocols such asSSH,FTP, SFTP &HTTP, as well as the ability to use diagnostic tools such as "traceroute", ping, profilers and dig. · Strong command line Linux skills. You should have setup and run your own Linux servers before. · Excellent Windows, Mac & Linux troubleshooting ability. · The ability to be a good listener, and to really understand a customer problem or question and help them solve it. · Excellent writing skills. Most of the work will be written (email, documentation, etc.). · Excellent telephone mannerisms. A large amount of supportwill be provided over the phone · 2-3 years previous experience in a L2 or L3 technicalsupport role · Must be proficient in Word, Excel, Powerpoint FLSA Category:Exempt2012-05-09 04:54:33United StatesQuintilesMassachusetts1206781MACambridge, MA28567759http://quintiles.jobs/xml/28567759/jobUSAPhoenixTitle: Prime Site Manager - Phoenix, AZ Location: USA-Arizona-Phoenix Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. Primary Job Function: Develop/implement/execute overall strategy (including contingency planning and adaptation) for Quintiles' prime site and alliance in Phoenix. Responsible for identification and placement of Quintiles studies based on site's general capabilities, research interests and expertise. Ensure individual studies, research programs and site portfolio are delivered on time and with high quality. This position is home based. Ideal candidate will live in Phoenix, Arizona. Job Responsibilities: * Lead the Joint Operations Steering Committee (JOSC) for the alliance * Ensure identification of appropriate membership from both Q and site * Schedule, prepare, lead and document regular meetings, in accordance with global guidelines * Follow up on agreed action items * Escalate gating items to regional and global site management * Schedule and participate in regular (1-2 times/year, F2F) executive steering committee meetings * Complete and regularly update site assessment (creating site profile) * Prepare monthly reports on site's KPIs, highlighting success, progress, issues - follow up, as appropriate * Develop and expand the local research network in alignment with Quintiles' anticipated therapeutic needs and study volume * Includes navigating political landscape to achieve physician and administrator engagement * Includes expansion into previously untapped therapeutic/development phase areas - i.e., primary care, late phase, biosimilars * Serve as "brand manager" for the Quintiles alliance and ensure relevant Prime Site/Alliance personnel are aware of and have bought into the goals and objectives of the alliance * Collaborate with Prime Site to develop, implement, and manage systems and processes related to research quality (position will have a dotted line reporting relationship to Quintiles' Clinical Operational Quality Management department) * Harmonize processes for more efficient administrative and operational study conduct * Work closely with QA to document understanding of local prime site processes and work flow, address and gaps/overlaps, and ensure compliance is joint activities increase/expand * Establish communication/feedback loops among Prime Site/Alliance study personnel and Quintiles study personnel and assist stakeholders with issue solution * Ensure Quintiles study placement * work within Quintiles to ensure opportunities are offered and Prime Site/Alliance are selected * work within Prime Site/Alliance to generate PI interest in specific studies * Facilitate quick study startup (feasibilities, regulatory, contracts, budgets) * Work with experts within Quintiles and the Prime Site/Alliance to develop robust patient recruitment plans for all studies, monitor effectiveness of such plans, and proactively adapt plans when necessary * Work with prime site/alliance to create pathways for areas of interest, including mapping of site's standard of care and studies (Q and non-Q) for specific indications (site research portfolio mapping) * Work directly with PIs and coordinators to implement and manage recruitment plans so that targets are met/exceeded within allotted enrollment windows * Develop patient education campaigns (non-study specific) MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelors degree * 7 years' experience in clinical research, with strong knowledge of drug development and CRO operations (monitoring, line management, and project management experience are strongly preferred) * 3 years experience in a leadership capacity * Experience with developing and managing quality assurance at research sites * Strong cross-functional leadership and project management skills * Ability to communicate and present effectively to senior management REQUIRED KNOWLEDGE, SKILLS AND ABILITIES •General understanding of Clinical Development process. •Proficient in the use of Microsoft Office. •Effective time management skills and ability to manage competing priorities. •Strong interpersonal skills. •Fluent in local language, both written and spoken. •Fluent in written English. •Ability to analyze performance data and draw relevant conclusions. •Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-05-09 04:54:06United StatesQuintilesArizona1207009AZPhoenix, AZ28567758http://quintiles.jobs/xml/28567758/jobUSAResearch Triangle ParkTitle: (ITLS) Technical Project Manager - Information Technology Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. Quintiles has made theComputerworld's "100 Best Places to Work in IT"in 2008, 2009 and 2011 and Quintiles IT is the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500". In 2011 Quintiles was also listed in the top 25 for multinationals by the Great Place to Work Institute. Quintiles Information Technology Unit is completing the implementation of a global adverse event processing and analysis platform. This platform has been designed to support operations and services for more than 50 clients worldwide with access by several hundred lifecycle safety associates and management located on 4 continents. As adoption of the platform increases, our Global IT team will expand to support platform enhancements, operations for internal Quintiles resources, as well as, many collaboration partners accessing the platform from outside. We are seeking people with experience in technical areas along with knowledge of drug safety solutions and process to join our team. Apply now for our Technical Account Manager position located in our Morrisville, NC office. Seeking a technical manager who will lead a team of approximately 20 people in completion of tasks related to implementation, enhancement and support of a large drug safety platform. The technical project manager will be part of the management team, focusing on the tasks, resources and timelines for technical tasks. These technical tasks include hardware & software selection, acquisition, installation, configuration, integration, documentation, tuning, and problem resolution. The ideal candidate has experience leading diverse teams of technology professionals, successfully completing tasks on time and with high quality. Experience implementing solutions in the pharmaceutical industry under the guidance of regulatory compliance is strongly desired. Responsibilities * Experience with interface and management of external customers * Work with project manager to develop and manage work breakdown structure (WBS) of technical tasks * Develop or update project plans for technical tasks including information such as project objectives, technologies, systems, information specifications, schedules, funding, and staffing * Manage project execution to ensure adherence to budget, schedule, and scope * Prepare project status reports by collecting, analyzing, and summarizing information and trends * Assign duties, responsibilities, and spans of authority to technical staff * Communicate to program management team resource requirements and issues * Assist in developing and managing budgets for technical tasks * Manage implementation plans * Contribute to financial planning and analysis on program efforts * Direct or coordinate activities of technical project personnel * Must be able to travel up to 20% * Track record of managing a team of technical people and a number of tasks * Experience with implementation of commercial software as well as integration efforts * Understanding and appreciation of accompanying documentation tasks * Knowledge of industry regulatory compliance * Strong communications skills, both internally and client-facing * Understanding of solutions supporting pharmaceutical R&D highly desirable * Understanding of biopharma product safety highly desirable * Experience with Oracle Argus (.Net) is preferable * Experience with Axway gateway products(J2EE) and Oracle RDBMS * 4-year college degree highly preferred * At least 7-10 years of applicable technical project management experience2012-05-09 04:54:05United StatesQuintilesNorth Carolina1207014NCResearch Triangle Park, NC28567756http://quintiles.jobs/xml/28567756/jobUSAPhoenixTitle: Regional Sales Director - Phoenix, AZ 6531 Location: USA-Arizona-Phoenix Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forRegional Sales Directorto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Regional Sales Director The Regional Sales Director will lead the primary care district management team for their region in promoting and selling healthcare products to general practitioners. The Regional Sales Director will coach the District Managers in the development and delivery of the sales strategy and be responsible for ensuring strategy execution and associated metrics. They will serve as a key information holder regarding the marketplace and thus, be able to react appropriately to that market as needed. They will also be responsible for delivering on all contractual obligations as agreed to with the client. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements · 4 year degree required · A minimum overall college GPA of 2.8/4.0 · 3 years experience and a proven track record as a District Sales Manager in the pharmaceutical market · Prior experience as a Regional Sales Director · Prior pharmaceutical sales experience required · Demonstrated ability to recruit, hire and coach District Managers to success · Proven ability to display district leadership, performance management & Career planning · Strong work ethic and customer focus orientation · Commutable distance to Purdue Regional Office, RSD will work out of regional office posted in job title on a daily basis unless in the field Competencies · Demonstrated analytical skills · Demonstrated Business Acumen · Demonstrated success in persuasion, influence and negotiation skills · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Knowledge of and experience with the selling process · Initiative & execution-oriented · Teamwork2012-05-09 04:54:05United StatesQuintilesArizona1207015AZPhoenix, AZ28567757http://quintiles.jobs/xml/28567757/jobUSALos AngelesTitle: Entry Level Clinical Research Associate / CRA / Western Region Location: USA-California-Los Angeles Other Locations: USA-California-Mountain View, USA-California-San Jose, USA-California-Santa Barbara, USA-California-San Diego, USA-California-San Francisco, USA-Arizona-Phoenix Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. This entry level CRA role can be home-based anywhere in the Western Region. * BS/BA Degree REQUIRED. * At least 3 years of clinical research coordinator experience * Customer service orientation. * Sound knowledge of medical terminology and clinical monitoring process. * In depth therapeutic and protocol knowledge as provided in company training. * Ability to perform regionalized, overnight travel an average of 65%, depending on project needs. * Excellent verbal and written communications skills. * In depth therapeutic and protocol knowledge as provided in company training. * Excellent interpersonal and organizational skills and attention to detail. * Computer literacy, proficiency in MS Office.2012-05-09 04:54:04United StatesQuintilesCalifornia1207018CALos Angeles, CA28567754http://quintiles.jobs/xml/28567754/jobUSAResearch Triangle ParkTitle: Sr Medical Dir--Ophthalmology Location: USA-North Carolina-Research Triangle Park Other Locations: JOB DESCRIPTION PURPOSE To provide medical, clinical, and scientific advisory expertise to all QTRN divisions as requested. The Senior Director participates in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES ? Serves as Regional Medical Advisor and/or Global Medical Advisor on assigned projects. ? Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. ? Performs review and clarification of trial-related Adverse Events (AEs). ? Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative. ? Provides medical support for the Analysis Of Similar Events (AOSE). ? Performs medical review of Adverse Event coding. ? Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). ? Performs medical review of the Clinical Study Report (CSR) and patient narratives. ? Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at the investigative sites. ? Attends and presents at the Investigator Meeting(s). ? Provides therapeutic area/indication training for the project clinical team. ? Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. ? Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. ? Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. ? Participates in the development of Medical & Scientific Services portion of client proposals including the budgeting process. ? Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. ? Provides expert consultation to NovaQuest, the Partnering Group of Quintiles Transnational, and supports the due diligence research of select compounds and/or companies as requested. ? Budget responsibility for select projects; responsible for select NovaQuest projects and responsible for all project safety issues on assigned trials. ? May serve as Regional Medical Director or Regional Therapeutic Head for smaller teams or regions. ? Participates in management level meetings within Medical & Scientific Services. Page 2 ? Maintains awareness of industry developments and participates in professional meetings, and may author related publications. ? Performs special projects as requested by management. All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs ? Ability to establish and meet priorities, deadlines, strategic department goals and objectives. ? Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. ? Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE ? A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required, plus a minimum of 5 years' experience in clinical medicine, in addition to 8 years' clinical development experience in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS ? Extensive use of telephone and face-to-face communication requiring accurate perception of speech. ? Extensive use of keyboard requiring repetitive motion of fingers. ? Regular sitting for extended periods of time. ? Frequent travel.2012-05-09 04:54:00United StatesQuintilesNorth Carolina1206886NCResearch Triangle Park, NC28567753http://quintiles.jobs/xml/28567753/jobUSABaltimoreTitle: Nurse Educator - Baltimore/Washington D.C. - 4409 Location: USA-Maryland-Baltimore Other Locations: USA-District of Columbia-Washington Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 40 Health Management Services teams, and hired more than 800 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our Clinical Educators interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Nurse Educator is a field -based healthcare professional, representing a major Pharmaceutical company, who is responsible for providing education, training, clinical in-services, and information regarding an injectable pharmaceutical product to Rheumatology and Gastro-Intestinal offices. The Nurse Educator will facilitate, organize, and deliver education on the product for health care staff and facilitate roundtable discussion groups with nurses and physicians, on various topics related to the product. Education will be done through presentations and workshops. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at: www.quintiles.com/careers. Quintiles is an Equal Opportunity Employer Qualifications: * Registered Nurse (RN) license required. * Bachelor's degree or extensive industry/clinical experience required. * Nurse Practitioner preferred. * Rheumatology/GI experience preferred. * Industry experience helpful. * Nurse educator experience preferred. * Biotech experience preferred. * Current license in good standing, willingness to travel. * Good presentation and communication skills required. * Enthusiastic, good attitude and ability to motivate others.2012-05-09 04:53:58United StatesQuintilesMaryland1206993MDBaltimore, MD28567752http://quintiles.jobs/xml/28567752/jobUSAMariettaTitle: Proposal Developer II Location: USA-Georgia-Marietta Other Locations: Quintiles conducts both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Proposal Developer I/II to join our team! Purpose: Collaborate with the Sales Team in the winning of business to achieve agreed sales targets. Responsible for preparing high quality customer focused proposals. This responsibility includes preparing the text and budget for proposals, re-bids, and related documents for manager's approval. Manages proposal development process including timeliness and quality of incoming comments and proposal content from Global Operations Heads (GOHs), Operations, Project Management, Sales/Business Development, and Sr. Management and ensures consistency between text and budget. Performs as Team Leader on assigned projects or supports Senior Proposal Developer in Priority One opportunities. Responsibilities: * Participates as a part of the dedicated team to ensure consistency in approach, metrics, and format for assigned customers as a team member. Assists in preparation, review and finalization of proposals/budgets. * Participates in resource calls with clients to discuss their needs. Must be able identify discrepancies in client information. * Solicits input from and effectively communicates all Customer Information received to Quintiles' stakes holders including managing strategy calls and regular interactions (e-mail, phone calls, etc...) with Quintiles' Operations, Project Management, Business Development, and if necessary, Global Operations Heads(GOH), Senior Management, Finance, Contracts, and Customers to prepare and finalize proposals. * Prepares and Develops proposal text and budgets, customizing all documents to accurately reflect services to be provided. Oversees the finalization of documents and distributions to the customer and internal departments. * May serve as a lead for assigned customers; developing proposal and budgets. * Develops working relationships with customer contacts and responds to customer specific requirements. * Conducts verbal and/or written follow up with clients after the submission of proposals as needed. * Updates and maintains corporate database(s) (CRM) as required. * Ensures accurate information is included in tracking reports (specifically CRM). * Reviews Request for Proposal (RFPs) to identify necessary information for proposal text and budget development. * Participates in the development of department procedures and processes. * Attends and participates in Proposal/Contract Transition meetings. * Attends and participates in Global Proposal Team meetings. * Performs quality control edits on all documents. * Performs all other duties as assigned. * At minimum, Bachelor's Degree in Life Science (primary consideration), business management, or other related field (secondary) preferred. * Clinical and/or Laboratory Experience Preferred * A minimum of 1 year direct experience in proposal development or 3 years marketing, business management/development, or other comparable combination of education, training and experience. * Possess excellent organizational skills and attention to detail. * Possess excellent communication skills, both verbal and written. * Possess strong interpersonal skills with the ability to manage multiple projects. * Ability to prepare and interpret budgets. * Ability to learn and use current pricing models (i.e. PSB) * Demonstrated working knowledge of WordPerfect, Word for Windows, Excel and windows based e-mail systems preferred. * Must posses superior editing skills.2012-05-08 04:41:32United StatesQuintilesGeorgia1205249GAMarietta, GA28500000http://quintiles.jobs/xml/28500000/jobUSABostonTitle: Specialty Sales Representative, Renal - Boston, MA 7071 Location: USA-Massachusetts-Boston Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Specialty Sales Representatives to join our team of over 7,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Specialty Sales Representative The Specialty Sales Representative targets, promotes and sells prescription products to Nephrologists and general practitioners. The Specialty Sales Representative manages their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. They provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements: * Bachelors degree * Candidates must have a minimum of three to five years of successful field sales experience; pharmaceutical or medical sales * Renal sales experience a plus, previous specialty sales experience highly preferred * Previous and proven sales success, award winners preferred * Superior sales, analytical, and organizational skills are essential. * Must reside within territory geography * Candidates must be in good standing for the previous 2 years with current company * Demonstrated ability to work as a team player Competencies: * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated leadership ability * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-08 04:41:29United StatesQuintilesMassachusetts1206926MABoston, MA28499999http://quintiles.jobs/xml/28499999/jobUSAMariettaTitle: Contracts Analyst 1 Location: USA-Georgia-Marietta Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians and providing nurses to educate patients or prescribers. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Contracts Analyst I to join our team! PURPOSE Owns the contracts process and work proactively with Operations and Business Development in the development and execution of the contractual process from verbal win through to project close with a primary focus on Customer satisfaction with Quintiles' contracting process. Routinely interacts with Quintiles' Operations, Business Development, Finance, and Customers to prepare and finalize project contracts and contract modifications/change orders. RESPONSIBILITIES * Contracts lead on small to mid-size projects * Works independently with Project Managers and customer on assigned projects, and provides support to Sr. Contracts Analyst and Contracts Manager on larger customers/projects * Revises or develops the budget and scope of work, to ensure the scope of work is defined correctly and the budget accurately reflects the scope. * Prepares cash flow and payment schedule. * Negotiates legal contracting text using Quintiles Global Contracting Policy, templates and fallbacks. * Prepares contract modifications and change orders, including scope of work revisions and budget modifications. * Customizes all documents to accurately reflect services to be provided, oversees finalization of documents and distributions to the customer and internal departments. * Accomplishes assigned projects and priorities as set by Manager; brings conflicting priorities to Manager's attention for resolution * Follows all Global Contracts review processes so that a quality product is delivered to both internal and external customers * On an ongoing basis, update and maintain contract databases and files based on Global Contracts processes * Attends monthly Project Review meetings as requested by Manager * Supports departmental activities directed toward meeting planned and projected Corporate goals including sales/revenue/customer satisfaction goal * Works within the department's metrics/timelines for completion of documents. * Participates in the development of department procedures and processes. * Performs all other duties as assigned . MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelors degree (Business, Finance, or Science Degree preferred) with a minimum of 0-2 years experience preferably in budgeting, finance, proposal development or contracts management; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience. * Customer centric, self motivated, and proactive * Knowledge and understanding of a clinical research/pharmaceutical environment preferred * Above average organizational skills and attention to detail required * Excellent communication skills, both oral and written * Excellent interpersonal skills, organizational skills and time management * Flexibility in responding to job demands * High Proficiency in Word, Excel and Lotus Notes * Ability to establish and maintain effective working relationships with direct reports, colleagues and managers2012-05-08 04:41:28United StatesQuintilesGeorgia1206122GAMarietta, GA28499998http://quintiles.jobs/xml/28499998/jobUSAResearch Triangle ParkTitle: Assoc. Director, Evidence-Based Sales Analytics Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Manage and direct the analytic program and operations for Evidence-Based Sales through identification of the data analyses needed to differentiate Quintiles from its competitors with its various customer segments through interface with the sales teams and other key stakeholders; identification of the proper data sets needed for analysis, analysis of the data, synthesis of the results, determine of implication of results for overall sales strategy, and effective communication of the results to key stakeholders; tracking of usage and measurement of impact of analyses with sales team and external customers RESPONSIBILITIES · Develop evidence-based hypotheses that ultimately prove the value of Quintiles to its customers · Support these hypotheses through the proper identification, acquisition, and cleaning of data sets needed to prove/disprove hypotheses · Working in collaboration with other analytic experts within Quintiles (when needed), perform analyses · Synthesize results and determine implications for sales · Perform quality control edits on all documents before issue to our internal or external customers · Communicate in a clear and easy to understand manner all analytic outputs to sales management, sales colleagues and other stakeholders · Present or assist in presenting analytic results to biopharma customers, when requested · Handle personnel issues, conflict management, define goals that increase knowledge and skills of staff, and define staff expectations, without involvement of senior managers · May participate in mentoring, training, and coaching new staff · Attend and participate in Team teleconferences and meetings as necessary · Perform all other duties as assigned REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Strong understanding of data organization, statistical interpretation of data, synthesis of findings, and appropriate reporting · Excellent Knowledge of Quintiles clinical operating data systems, e.g., Inntrax, CTMS, IPD, QRPM, data warehouse and Quintiles Infosario · Understanding of Biopharmaceutical industry and business trends · Knowledge industry- specific databases such as ADIS, Evaluate Pharma, Data Monitor preferred · Ability to manage multiple day to day projects · Ability to establish and maintain effective working relationships with coworkers, managers and customers · Highly organized and methodical with good project management skills · Ability to be self-directed, prioritize opportunities and perform multiple tasks · Ability to maintain demanding timelines · Possess strong organizational skills and attention to detail · Excellent knowledge of Microsoft Office, SpotFire, and other statistical software MINIUM REQUIRED EDUCATION AND EXPERIENCE · Degree in Business Management, Statistics, Science or other related discipline and 5 years related experience with a minimum of 1 year line management experience; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS ? Extensive use of telephone and face-to-face communication requiring accurate perception of speech ? Extensive use of keyboard requiring repetitive motion of fingers ? Regular sitting for extended periods of time ? Occasional travel2012-05-08 04:41:04United StatesQuintilesNorth Carolina1206677NCResearch Triangle Park, NC28499996http://quintiles.jobs/xml/28499996/jobUSARaleighTitle: iCRA Line Manager, Project Coordination Centre- RTP, NC Location: USA-North Carolina-Raleigh Other Locations: Quintiles is the only fully integrated Biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. We are continuously in search of talent that can help advance our mission. Currently we are seeking aManager, Project Coordination Centre. This position is office based in RTP. The Manager, Project Coordination Centre will manage a team of remote monitoring staff within a region. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. Ensure that clinical Project Coordination Centre (PCC) staff gain the necessary skills to perform their respective job Responsibilities. RESPONSIBILITIES •Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. •Participate in the selection and on-boarding process for new PCC staff by conducting candidate review and participating in the interviewing process. •Ensure that PCC staffs have the appropriate materials and systems access to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. •Ensure that PCC staff performs their tasks within scope, timelines and budget. Regularly review and approve time coded by direct reports. • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. •Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in PCC performance. •Advise on audit preparation, attend pre and post audit meeting, oversee follow-up actions and ensure timely implementation and completion of corrective action plans. • May participate in corporate or departmental quality or process improvement initiatives. Bachelor's degree in a health care or other scientific discipline or educational equivalent and 6 years experience working on clinical research (remote or on-site clinical monitoring) including 3 years experience in a leadership role ; or equivalent combination of education, training and experience •Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines •Strong leadership skills •Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint •Strong written and verbal communication skills including good command of English •Excellent organizational and problem solving skills •Effective time management skills and ability to manage competing priorities •Effective mentoring and training skills •Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-05-08 04:40:40United StatesQuintilesNorth Carolina1206936NCRaleigh, NC28499995http://quintiles.jobs/xml/28499995/jobUSAResearch Triangle ParkTitle: Director/Sr. Director Customer Delivery - Safety Publishing Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Serves in a senior strategic leadership position within Lifecycle Safety, Service Operations (SO), developing global, cross-functional integrated delivery plans for safety publishing throughout all stages of the Lifecycle Safety opportunity chain. Provides thought leadership for a combination of designated Lifecycle safety publishing service lines and direction for specified accounts. Participates actively in local and global initiatives, as needed. Provides line management for global assigned staff who are deployed in Safety Publishing leadership roles. RESPONSIBILITIES * Develop and maintain a high quality and efficient safety publishing Centre of Excellence (CoE) team, Develop and review the team reporting structure for Quintiles while adhering to governing standard operating procedures (SOPs), work instructions and applicable regulatory guidelines and regulations. * Initiate, lead, implement and support operational decisions in collaboration with senior management. Ensures financial project performance through oversight of key performance metrics. (revenue, direct costs, time-sheet costs, utilization and realization) and develop a competitive pricing for the service operation of the CoE * Act as mentor and coach to less experienced safety publishing managers, as appropriate. * Lead and encourage direct reports in continuous improvement of safety publishing processes, procedures and infrastructure * Support ongoing overarching operational, strategic and tactical initiatives as assigned/agreed, ensuring timely and complete delivery. * Direct project resource assignments including staff hiring, and training in collaborations with senior management. * Work closely with global head, LS Quality to ensure appropriate and consistent quality monitoring in safety publishing teams. * Direct and/or participate in cross-functional teams and other process improvement initiatives. * Participates actively in local and global initiatives, as needed. * Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning and directing work; appraising performance and guiding professional development; rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources. * Perform other duties as assigned. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Excellent team leadership and customer services skills; strategic customer focus. * Experience in safety publication of all types of documents including benefit and risk management plans * Strategic understanding of business processes across opportunity chain and all phases of product lifecycle. * Ability to apply industry awareness and business acumen to strategic planning. * Excellent analytical, judgment and decision-making skills. * Excellent innovation/solutioning skills. * Excellent communication (written and verbal) and presentation skills. * Strong problem-solving, influencing, negotiation, conflict management and collaboration skills. * Strong progressive mentoring and coaching skills. * Strong software and computer skills. * Highly effective time management and delegation skills, ability to manage multiple competing priorities, meet multiple demanding timelines and work creatively in fast-paced environment. * Strong ability to deliver results to the appropriate productivity, budgetary and quality metrics. * Demonstrated flexibility, initiative, proactivity, ownership and accountability. * Solid technical financial management knowledge and skills including the ability to read and analyze P&Ls, performance metrics, develop plans for improvement, contribute to pricing discussions. * In depth knowledge of and ability to apply GCP/ICH/Good Pharmacovigilance Practice and applicable regulatory guidelines. * Strong ability to establish and maintain effective working relationships with coworkers, managers and customers. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree or educational equivalent, preferably in health science or related area and 12 years research experience in Contract Research Organization or Pharmaceutical company, including 9 years management experience; or equivalent combination of education, training and experience. Experience of leading a global team of professionals in safety publishing. PHYSICAL REQUIREMENTS * Extensive use of keyboard requiring repetitive motion of fingers. * Extensive use of telephone and face-to-face communication requiring accurate perception of speech. * Regular sitting for extended periods of time. * Requires occasional to frequent domestic and international travel.2012-05-08 04:40:39United StatesQuintilesNorth Carolina1206949NCResearch Triangle Park, NC28499994http://quintiles.jobs/xml/28499994/jobUSAFort WayneTitle: Cardiology Specialty Sales Representative - Ft. Wayne/Northern Indianapolis Suburbs, IN 6594 Location: USA-Indiana-Fort Wayne Other Locations: USA-Indiana-Indianapolis As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-07 04:54:44United StatesQuintilesIndiana1206900INFort Wayne, IN28472161http://quintiles.jobs/xml/28472161/jobUSACambridgeTitle: Associate Systems Analyst - Outcome, Cambridge MA Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: The Associate Systems Analyst will define technical requirements and create/approve project specifications, while communicating with all departments to facilitate successful project delivery to the client. This individual will create standard and custom EDC project requirement specifications, improve the quality and coverage of technical documentation and manage specification approval process. Primary Responsibilities: * Creates standard and custom EDC project requirement specifications * Improves the quality and coverage of technical documentation * Works with management to identify and prioritize documentation needs * Maintains a rapport with Development, Quality teams and promotes good documentation and communication practices * Manages specification approval process * Acts as a designated contact for documentation improvements for external and internal projects * Maintains the overall structure of the documentation template set Requirements: * Bachelors degree * Great interpersonal and communication skills and the ability to multi-task * Superior written and verbal communication skills with an ability to write clearly and concisely and a strong attention to technical detail * Ability to grasp technical concepts quickly, understanding of Java and web technologies is preferred * Must enjoy the challenges of owning and developing a wide range of documents necessary to support the full development life cycle2012-05-05 04:20:03United StatesQuintilesMassachusetts1206609MACambridge, MA28462922http://quintiles.jobs/xml/28462922/jobUSACambridgeTitle: Technical Project Manager: Cambridge, MA Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: To define technical requirements for Electronic Data Control (EDC) systems, manage a cross functional project team and communicate directly with clients to facilitate successful project delivery Primary Responsibilities: * Facilitate and lead requirements gathering discussions with multiple clients * Translates client requirements into technical specifications for new study start-ups and existing EDC-systems * Manage multiple client projects simultaneously * Collaborates and partners with Project Manager and directly with client to ensure that both the client and Outcome have a clear and consistent understanding of the system requirements and project scope * Works with CTS Manager and Technical Project Consultant to ensure specifications are complete and accurate to client requirements * Responds to EDC-related questions from internal and external team members * Facilitates and manages internal communications regarding EDC system deliverable timelines * Develops clear and comprehensive understanding of project budgets with regard to the EDC setup * Proactively raises scope and timeline issues for EDC systems and facilitates internal discussions to define the best approach to client communications * Creates change order documentation when updates to EDC systems are required by client to define scope and works with internal project resources in all departments to obtain required estimates and approvals * Reviews updated changes to an EDC system in the testing environment and reviews Live builds * Investigates technical issues found in the Live system and schedules issues resolution timelines for internal team members and client * Coordinates resolution of client User Acceptance Test findings and change requests * Develops documentation templates and best practices to enhance efficiency and effectiveness of technical requirements gathering process * Provides mentoring to and manages TPC role * Provides training to ATPC, TPC and TPC roles Requirements: * Bachelors degree in engineering or computer science * Experience should be either 4 years of engineering or software development or 4 years as a writer of high-quality technical documentation and specifications * Superior written and verbal communication skills with an ability to write clearly and concisely and a strong attention to technical details * Ability to grasp technical concepts quickly, understanding of Java and web technologies * Must enjoy the challenges of owning and developing a wide range of documents necessary to support the full software development life cycle2012-05-05 04:20:02United StatesQuintilesMassachusetts1206611MACambridge, MA28462921http://quintiles.jobs/xml/28462921/jobUSAHawthorneTitle: Principal Consultant, Health Outcomes Researcher Location: USA-New York-Hawthorne Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Quintiles is currently seeking aHealth Outcomes Principle Consultantto join our team. Specific responsibilities to the role may include: * Managing client engagements * Manage Business Development responsibilities, including proposal writing and bid defenses * Design project research, analysis, and reporting techniques, as well as, project plans * Oversee the development of project research materials including protocols, analysis plans, surveys, discussion guides, and other data collection instruments * Negotiate contracts * Supervise multiple workstreams * Oversee production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, abstracts, manuscripts, and product dossiers * Manage the development of staff Sample Engagements could include: * Business process transformation reengineering * Market assessment, evaluation and forecasting * Portfolio strategies * Pricing and reimbursement strategy development and support * Health economic evaluations and health technology assessments * Product positioning and development * Risk-Benefit Analysis * Therapeutic and technical support * Scenario planning * Licensing and partnering strategies * Due diligence * Applied epidemiological investigations * Disease area reviews and modeling * Value dossier development * Quality of Life studies * Bachelor's degree required * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * 5 years in Consulting, with a preference in Life Sciences Consulting and Health Outcomes * Strong computer skills, including programming (e.g. Visual Basic, SAS), database mining, statistical software package experience and Microsoft Office applications * Strong Epidemiologic understanding * Superior analytical, communication, and presentation skills (sample will be required) * Has experience and abilities in the following areas: research and development, discovery, business process re-engineering, clinical development, product development, commercialization of drugs, due diligence, technical writing, and presentation skills * Ability to travel to the client site as necessary2012-05-05 04:19:49United StatesQuintilesNew York1206428NYHawthorne, NY28462920http://quintiles.jobs/xml/28462920/jobUSADurhamTitle: Associate Medical Director/Medical Director/Sr. Medical Director/Endocrinologist, Cardiovascular & Metabolic TDU Location: USA-North Carolina-Durham Other Locations: USA-Georgia-Atlanta, USA-Maryland-Rockville, USA-New Jersey-Parsippany, USA-California-San Diego, USA-Kansas-Overland Park The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas and post-marketing support of authorized products around the globe. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people everywhere. Let your career soar! We are seeking an enthusiasticAssociate Medical Director/Medical Director/Sr. Medical Director/Endocrinologist, Cardiovascular & Metabolic Therapeutic Delivery Unit, to join our Medical and Scientific Services team! The Endocrinologist will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbentwill participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES * Serves as Regional Medical Advisor on assigned projects. * Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. * Performs review and clarification of trial-related Adverse Events (AEs). * Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative. * Provides medical support for the Analysis Of Similar Events (AOSE). * Performs medical review of Adverse Event coding. * Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). * Performs review of the Clinical Study Report (CSR) and patient narratives. * Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites. * Attends and presents at Investigator Meetings. * Provides therapeutic area/indication training for the project clinical team. * Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. * Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. * Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. * Participates in development of Medical and Scientific Services portion of client proposals including the budgeting process. * Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required. Plus, a minimum of 5 years experience in clinical medicine, inclusive of post-graduate medical education, is required. Clinical development experience in the Pharma, CRO, or Biotech industry and knowledge of drug and device safety regulations are preferred. Specialty Board certification or equivalent combination of education, training and experience is desirable. General skills required include: * Ability to establish priorities and meet deadlines and objectives in a demanding environment * Skills in providing consultation and advice on multiple assignments as well as initiative and flexibility * Ability to establish and maintain effective working relationships with coworkers, managers, and clients2012-05-05 04:19:14United StatesQuintilesNorth Carolina1206849NCDurham, NC28462919http://quintiles.jobs/xml/28462919/jobUSAPensacolaTitle: Certified Diabetes Educator, Pensacola, FL - 4236 Location: USA-Florida-Pensacola Other Locations: Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 40 Health Management Services teams, and hired more than 800 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our Clinical Educators interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Diabetes Clinical Educator will educate primary care providers, and their staff and patients regarding diabetes disease management as it relates to product specific training. The Diabetes Clinical Educator will enroll the providers in this program. This is a full-time, field-based position. As an innovative employee, you will enjoy our generous compensation/benefits program, which includes: medical/dental/life/vision insurance programs; 401(k) with company match; bonus plan, auto allowance. Average Salary for this position is 80K. For more information or to apply for this opportunity, visit us online atwww.quintiles.com/careers Be sure to refer to job code: 4236 EOE Successful candidate will possess: •CDE (Certified Diabetes Educator) REQUIRED •Baccalaureate degree required •Excellent written and oral skills •Excellent presentation skills2012-05-05 04:19:14United StatesQuintilesFlorida1206862FLPensacola, FL28462918http://quintiles.jobs/xml/28462918/jobUSAHawthorneTitle: Consultant, Economic Modeler Location: USA-New York-Hawthorne Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Specific responsibilities to the role may include: * Contribute to proposal writing * Contribute to the design/delivery of project research, analysis plans, presentations, abstracts, manuscripts, and product value dossiers * Review published medical and economic literature to capture model inputs * Conduct interviews with physicians and other decision-makers * Supervise analysis and interpretation of data * Design and conduct health economic analyses for health interventions or specific health technologies, to produce health economic models ( Markov, decision analytic ) * Budget Impact * Direct and Indirect cost offset * Burden of Illness / Treatment cost * Relevant degree in Health Economics or equivalent and at least 2 years experience with consulting * Fluent with decision-analytic techniques, including programming of health-economic models * Strong computer skills, including programming (e.g. Visual Basic, SAS), database mining, statistical software package experience and Microsoft Office applications * Good verbal and written communication skills * Strong analytical skills * Excellent customer service skills * Ability to work within a matrix team environment2012-05-05 04:19:10United StatesQuintilesNew York1206867NYHawthorne, NY28462917http://quintiles.jobs/xml/28462917/jobUSALong IslandTitle: Multiple Sclerosis Nurse Educator - Long Island/Brooklyn/Queens, NY- 4202 Location: USA-New York-Long Island Other Locations: USA-New York-Brooklyn Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 40 Health Management Services teams, and hired more than 800 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our Clinical Educators interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Clinical Educator will provide focused home-based patient education regarding treatment of Multiple Sclerosis. Also provides specialized education and training to homehealth care agencies, physicians, nursing and office staff within a defined geographic region. Conduct training presentations to Multiple Sclerosis support groups regarding treatment of the disease. Occasional travel overnight for meeting attendance required. This is a full time, field-based position. As an innovative employee, you will enjoy our generous compensation/benefits program, which includes: medical/dental/life/vision insurance programs; 401(k) with company match; bonus plan, auto allowance. For more information or to apply for this opportunity, visit us online atwww.quintiles.com/careers Be sure to refer to job code: 4202 EOE Requirements and Skills: -RN required -Four-year degree preferred. -Current license in good standing. -MS/Neurological experience preferred. -Home health care experience helpful. -Excellent presentations skills. -Valid drivers license. -Ability to manage multiple tasks.2012-05-05 04:19:05United StatesQuintilesNew York1206846NYLong Island, NY28462916http://quintiles.jobs/xml/28462916/jobUSAOverland ParkTitle: Assistant/Associate Clinical Data Manager, Pharmaceutical Research Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Associate Clinical Data Manager will provide expert skills as part of a Clinical Data Management team to provide efficient, quality data management products that meet customer needs. Provide leadership to the team in the area of Project Management and viewed as an expert in data management. Will provide leadership to the team as Data Team Lead (DTL), Data Operations Coordinator (DOC) or Subject Matter Expert for DTLs or DOCs. RESPONSIBILITIES • Serve as Data Team Lead (DTL) on a program of 6-10 global studies. • Manage DM customer relationship for DM project team to include leading (with minimal guidance) DM customer negotiations on complex timeline, budgetary and other issues. • Provide marketing capabilities presentations and business development presentations. • Manage delivery of projects through full data management process life-cycle. • Manage project timelines, quality issues, resources, SOW (scope of work) / budget. • Manage comprehensive data management tasks pertaining to the Data Management Plan. • Manage comprehensive quality control procedures. • Provide data management expertise and data coordination process improvement to CDM management. • Mentor other team members and Lead Data Managers in training and developing data management expertise. • Independently bring project solutions to the CDM team and the CDM Department. This position may be filled as an Associate Data Manager (31) or Assistant Data Manager (30) depending upon education, training, and experience. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Thorough knowledge of the data management process and experience in specialized data management skills • Knowledge of operating procedures and work instructions and the ability to apply them in practice • Excellent experience and organizational, communication, and demonstrated expert data management skills • Comprehensive understanding of clinical drug development process MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 3 years relevant experience2012-05-04 04:31:17United StatesQuintilesKansas1206656KSOverland Park, KS28426918http://quintiles.jobs/xml/28426918/jobUSAOverland ParkTitle: Senior Statistical Programmer, Pharmaceutical Research Location: USA-Kansas-Overland Park Other Locations: Quintiles is looking for an energetic, highly qualified individual with early development experience to join our Scientific Operations Statistical Programming team in Overland Park, Kansas. The selected individual will be experienced, comprehensive, and have knowledge of advanced technical expertise in order to be a part of the Statistical Programming (SP) team to develop process methodology for the department and to meet internal and external clients' needs. This position requires the ability to plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical analysis needs. Qualified individual will provide advanced technical expertise to the Statistical Programming department and provide internal consulting services, including specifications and user needs analysis for complex project, client requirements and/or the implementation of new technologies. Qualified individual will hold a Masters degree or educational equivalent in computer science or related field and 5 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 6 years relevant experience; or equivalent combination of education, training and experience. Related experience needs to have included the following skills: • Knowledge of statistics and/or clinical drug development process • Advanced knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Knowledge of electronic submissions (including: knowledge of data submission structures and requirements; experience increating relevant hyperlinks, etc) to include experience with creation of define.xml, define.pdf, and data definition specification documents. • Very good organizational, interpersonal, leadership and communication skills • Ability to effectively manage multiple tasks and projects • Excellent accuracy and attention to detail • Ability to effectively delegate work • Ability to effectively motivate other staff members2012-05-04 04:31:03United StatesQuintilesKansas1206520KSOverland Park, KS28426917http://quintiles.jobs/xml/28426917/jobUSANoneTitle: Therapeutic Strategy Lead - Respiratory Location: United States Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Project Management group is seeking a Therapeutic Strategy Lead with Respiratory experience to join the team. PURPOSE Serve as a Strategic Therapeutic expert in applying therapeutic knowledge to proposal strategies and drug development opportunities, influencing customers regarding clinical development approaches and decisions. Activities will have a direct impact on increasing sales. Serve as a key advisor and partner with the therapeutic operational delivery teams to align strategies and direction to deliver quality results with high focus on therapeutic differentiation. RESPONSIBILITIES · Provide strategic drug development advice to customers and internal teams · Participate in overall strategic drug development plans and development of clinical protocols by incorporating innovative designs and creating exceptional value · Help drive strategy, due diligence and business planning for potential partnerships · Provide oversight of the comprehensive drug development process · Define, review and sign off proposal strategies and budgets within assigned area. · Lead and/or attend Bid Defense or customer meetings as strategy expert as required . · Partner with key customers as a clinical trial expert and via governance structures. · Lead and implement strategic initiatives for business growth. · Lead and partner on strategic outsourcing decisions for third party providers. · Design, support, input and maintain protocol-specific and general disease therapeutic training across the TDU. · Foster and leverage relationships with Thought Leaders both internal and external to Quintiles. · Attend selected R&D/scientific/clinical public meetings as Quintiles' Therapeutic representative to keep abreast of current trends and developments from a scientific, customer and competitor perspective. · Participate in projects or initiatives as required. · Participate in the selection and hire of TDU staff. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in life sciences, advanced degree preferred with specialization in therapeutic area and 12 years' drug development experience, with 8 years experience in strategic project leadership. * Respiratory experience preferred. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Proven and demonstrable record in leadership of drug development implementation * Deep and current knowledge of scientific, clinical, regulatory and commercial landscape / literature in ID * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines * Excellent communication and interpersonal skills, including good command of English language * Strong leadership skills with proven ability to lead a virtual team in a matrix structure * Strong innovative capability * Excellent negotiation and influencing skills necessary to sell proposal strategy to customers * Strong strategic thinking ability * Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-05-04 04:30:47United StatesQuintilesNone1206788NoneVirtual, USA28426916http://quintiles.jobs/xml/28426916/jobUSAParsippanyTitle: Account Manager, Medical Communications, Parsippany, NJ Location: USA-New Jersey-Parsippany Other Locations: Account Manager - Medical Communications - US or UK based Quintiles currently has an exciting opportunity for a Account Manager to manage the planning, execution and measurement of account activities and programs through professional, consultative and proactive liaison. The ideal candidate for this role can either be based in either in Parsippany, NJ or Berkshire, UK. Successful candidates will have experience of the Pharmaceutical industry or agency background, in a matrixed organization, along with good knowledge of all aspects of Pharmaceutical marketing including key tactical services, including but not limited to, live event logistics and technical support, design & production digital & online. Key Responsibilities: · Work with Senior Account Managers and Account Directors to manage the development and delivery of high quailty account programs that meet the strategic needs of customers · Act as day to day contact with clients. Cultivate strong, long-term relationships with key decision-makers within client teams and develop in-depth knowledge of the customer organization · Manage account teams to deliver on all aspects of account activities including briefing, planning, scheduling, budgets and resourcing, ensuring the delivery of projects to agreed specification and quality within budget and timescales. · Ensure the strategic medical / marketing development of all account activities; review all deliverables to ensure they meet the strategic objectives of the client, adhere to clients' key marketing messages and are relevant to their target audiences. Review projects for quality assurance and high standards in conjunction with project editors. · Manage account finances, including development of account budgets, liaison for sign off, tracking of servicing levels and reporting on profitability. · Proactively initiate actions to maximize growth and profitability of accounts. Contribute to growth of existing accounts by working with senior account team to develop and execute a comprehensive business development plan for each target account. · Participate in proposal development and sales / proposal presentations. · Maintain thorough knowledge and understanding of pharmaceutical market issues, client and competitor company / product positioning. Continually assess and maintain an understanding of the landscape (activities, positioning and pricing). Quintiles Medical Communications is an international medical communications agency that develops and produces a broad range of communications programs and materials on behalf of pharmaceutical industry. Working with our pharmaceutical clients, our activities include organizing international symposia, developing educational programs for physicians and patients, producing clinical trial investigator and participant support materials, and developing print/digital materials ranging from sales aids to peer-reviewed publications. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! QUALIFICATIONS · Experience within the pharmaceutical industry or Medical Communications or Healthcare/PR agency environment. · Pharmaceutical and scientific background, ideally · International communications experience - preferred · Financial project management. · Pharmaceutical strategic marketing programs. · Implementation and monitoring of PR and Publication Planning projects. · Line management experience - preferred. · Bachelor's degree, or equivalent, in medicine, pharmacy, life sciences, marketing or other relevant area. · Must live locally and be office-based; occasional travel required2012-05-04 04:30:43United StatesQuintilesNew Jersey1204686NJParsippany, NJ28426915http://quintiles.jobs/xml/28426915/jobUSAParsippanyTitle: ENTRY LEVEL Account Executive, Medical Communications, Parsippany, NJ Location: USA-New Jersey-Parsippany Other Locations: ENTRY LEVEL Account Executive- Medical Communications - Parsippany, NJ Quintiles currently has an exciting opportunity for an Entry Level Account Executive to contribute to the planning, execution and measurement of account activities to the client's satisfaction , ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with Standard Operating Procedures (SOPs), policies and practices. The ideal candidate for this role should be based in Parsippany, NJ. Key Responsibilities: · Provide support to client team leaders in the development and delivery of account activities for internal and external customers · Attend client teleconferences and where appropriate, meetings, alongside other members of the project team. Maintain client contact as appropriate with the direction of other members of account team · Take responsibility for the delivery of identified account activities; assist with the coordination of schedules for allocated projects or items in conjunction with account manager, keeping account manager informed of progress · Liaise with internal departments as appropriate to coordinate delivery of projects, including scheduling and briefing. · Develop and maintain overview of project budgets and track regularly to ensure cost effective delivery of projects, reviewing with Account Manager regularly to identify any issues · Undertake background research for, assist in development of new and roll-on business proposals where appropriate. Identify any potential needs of existing clients · Coach and support the development of Account Coordinator as appropriate · Become familiar with the therapeutic areas of projects and develop understanding of client objectives, in addition to growing an understanding of pharmaceutical communications strategies and industry · Maintain general knowledge of all Quintiles' medical communication services Quintiles Medical Communications is an international medical communications agency that develops and produces a broad range of communications programs and materials on behalf of pharmaceutical industry. Working with our pharmaceutical clients, our activities include organizing international symposia, developing educational programs for physicians and patients, producing clinical trial investigator and participant support materials, and developing print/digital materials ranging from sales aids to peer-reviewed publications. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! QUALIFICATIONS · Bachelor's degree, or equivalent, in medicine, pharmacy, life sciences, marketing or other relevant area. · Knowledge of some aspects of pharmaceutical marketing including key tactical services including but not limited to live event logistics and technical support, design & production and digital & online communications · Experience of participating in teams · Demonstrated ability to work creatively in a fast-paced environment. Ability to maintain demanding timelines. Adaptability and flexibility to changing priorities and ability to work simultaneously on multiple priorities · Ability to establish and maintain effective working relationships with co-workers, managers and clients · Exceptional attention to detail · Flexible personality and a quick learner who operates with a sense of urgency · Strong communication and interpersonal skills including developing customer service skills · Strong capacity for understanding financial activities · Good problem solving skills · Strong organizational, planning and logistics skills, satisfactory project management skill development · Sound judgement and ability to distinguish when further supervision is required · Demonstrated ability to deliver results to the appropriate quality and timeline metrics· Strong software and computer skills, including MS Office applications2012-05-04 04:30:23United StatesQuintilesNew Jersey1204876NJParsippany, NJ28426913http://quintiles.jobs/xml/28426913/jobUSACharlotteTitle: Cardiology Specialty Sales Representative - Charlotte, NC/Columbia E, SC 6594 Location: USA-North Carolina-Charlotte Other Locations: USA-South Carolina-Columbia As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-04 04:30:20United StatesQuintilesNorth Carolina1206813NCCharlotte, NC28426909http://quintiles.jobs/xml/28426909/jobUSAFairfaxTitle: Cardiology Specialty Sales Representative - Fairfax, VA 6594 Location: USA-Virginia-Fairfax Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-04 04:30:20United StatesQuintilesVirginia1206815VAFairfax, VA28426911http://quintiles.jobs/xml/28426911/jobUSAPhoenixTitle: Cardiology Specialty Sales Representative - Phoenix/Mesa, AZ 6594 Location: USA-Arizona-Phoenix Other Locations: USA-Arizona-Mesa As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-04 04:30:20United StatesQuintilesArizona1206816AZPhoenix, AZ28426910http://quintiles.jobs/xml/28426910/jobUSAHartfordTitle: Cardiology Specialty Sales Representative - Hartford/Waterbury, CT 6594 Location: USA-Connecticut-Hartford Other Locations: USA-Connecticut-Waterbury As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-04 04:30:20United StatesQuintilesConnecticut1206817CTHartford, CT28426912http://quintiles.jobs/xml/28426912/jobUSAJacksonvilleTitle: Cardiology Specialty Sales Representative - Jacksonville/Daytona/Melbourne, FL 6594 Location: USA-Florida-Jacksonville Other Locations: USA-Florida-Daytona Beach, USA-Florida-Melbourne As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-04 04:30:19United StatesQuintilesFlorida1206812FLJacksonville, FL28426907http://quintiles.jobs/xml/28426907/jobUSATallahasseeTitle: Cardiology Specialty Sales Representative - Tallahassee/Pensacola, FL 6594 Location: USA-Florida-Tallahassee Other Locations: USA-Florida-Pensacola As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2012-05-04 04:30:19United StatesQuintilesFlorida1206814FLTallahassee, FL28426908http://quintiles.jobs/xml/28426908/jobUSAOmahaTitle: Clinical Research Associate / CRA / Sr CRA / Ohama Location: USA-Nebraska-Omaha Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located inthe Omaha area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-05-03 04:34:36United StatesQuintilesNebraska1206712NEOmaha, NE28355060http://quintiles.jobs/xml/28355060/jobUSAMinneapolisTitle: Clinical Research Associate / CRA / Sr CRA / Minneapolis Location: USA-Minnesota-Minneapolis Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located inthe Minneapolis area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-05-03 04:34:35United StatesQuintilesMinnesota1206714MNMinneapolis, MN28355059http://quintiles.jobs/xml/28355059/jobUSAMariettaTitle: Application Developer Location: USA-Georgia-Marietta Other Locations: United States Quintiles is currently seeking an Application Developer to support their Lab Data Management group in Marietta, GA (Atlanta area). The role is based out of Marietta, GA * Serve as Lead Programmer on the corporate team, providing programming expertise in .NET technologies (ASP .NET, VB .NET, C#) * Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems * Provide technical expertise in conjunction with internal and external clients. * Program, test, and document databases in accordance with programming standards and validation procedures. * Program database manipulation and transfers of data for internal and external clients. * Mentor other team members and Lead Programmers in training and developing technical and/or database expertise. * Independently bring project solutions to the CDP teams and the Clinical Data Programming department. * May assist IT in developing and implementing new technologies. * May assist IT in testing and evaluating new upgrades to technologies. * May assist in developing, revising, and maintaining core operating procedures and working instructions. * Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables. * Develop and maintain good communications and working relationships with teams and external clients. * * Bachelor's degree, or educational equivalence, in computer/life science or related field with 2-3 years of relevant work experience in .NET technologies (Visual Studio, C#, VB .NET, ASP .NET) * Knowledge of Clinical Drug Development and Oracle Clinical is a huge plus but not required * Excellent organizational, communication, and technical database skills * Ability to establish and maintain effective working relationships with coworkers, managers and clients * ~2012-05-03 04:34:29United StatesQuintilesGeorgia1205840GAMarietta, GA28355058http://quintiles.jobs/xml/28355058/jobUSANoneTitle: Sr Director, Legal Location: United States Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 23,000 engaged professionals in over 60 countries are committed to making people healthier. The work we do in every therapeutic discipline makes a difference in the lives of patients everywhere. For example, Quintiles has helped develop or commercialize 100% of all Diabetes products approved between 2004 and 2010. In fact, Quintiles has helped develop or commercialize all of 2010's top 50 best selling products or compounds. Join us as we define TheNewHealth. Quintiles is an Equal Opportunity Employer M/F/D/V. PURPOSE Assist with strategic and operational support for the office of the General Counsel. Provide counsel in the area of employment law and litigation. Coordinate legal matters handled by outside counsel. RESPONSIBILITIES The responsibilities of the role will include some or all of the following: • Provide legal advice regarding employment law. Liaise with Human Resources on all issues of the law related to the organization's human capital. Monitor legal issues and implications regarding discrimination, sexual harassment, retaliation, wrongful termination, reasonable accommodations, wage & hour class actions, employment contract disputes (non-competes), health and safety, hiring and firing, as well as all other aspects of employee rights and responsibilities. • May examine legal data to determine advisability of defending or prosecuting a lawsuit. Study statutes, decisions and ordinances to determine appropriate plan of action. Prepare files and take cases to trial if out-of-court settlements cannot be reached or coordinate such legal matters handled by outside counsel. Assess impact of case outcomes and initiate steps to implement any resultant changes. • May supervise outside counsel's performance of outsourced legal work for quality, cost, and effectiveness. • Execute strategic initiatives with guidance fro, senior management, including supervising projects and implementing policies. • May review due diligence and assist in the preparation of documents for corporate transactions. • Assist operations in assessing various risks associated within their respective business line. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · A deep understanding of state and federal labor and employment laws and regulations • Strong organizational, planning, project management, communication, presentation and influence skills. • Strong business acumen • Solid understanding of the pharmaceutical industry and/or drug development process • Demonstrated ability to work creatively in a fast-paced environment • Demonstrated sound decision-making skills • Excellent skills using MS Office Suite: MS Excel, MS Word, MS PowerPoint • Exceptional attention to detail and ability to work simultaneously on multiple priorities • Ability to work independently • Ability to articulate legal issues and effectively make recommendations at the Sr. Management level • Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree and JD with 12 years related experience, including 9 years of experience in employment law and/or employment litigation; or equivalent combination of education, training and experience.2012-05-03 04:34:18United StatesQuintilesNone1206674NoneVirtual, USA28355057http://quintiles.jobs/xml/28355057/jobUSAOverland ParkTitle: Sr Statistical Programmer - Overland Park, KS Location: USA-Kansas-Overland Park Other Locations: Quintiles is seeking an enthusiastic Sr Statistical Programmer to join our U.S. Biostatistics Operations team in Overland Park, KS. The Sr. Statistical Programmer will provide experienced technical expertise as part of the Statistical Programming (SP) team to develop process methodology for department to meet internal and external clients' needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical analysis needs. Provide technical expertise and leadership to the Statistical Programming department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. RESPONSIBILITIES • Program, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks. • Program and plan the integration of databases from multiple studies or sources. • Develop, plan, and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. • Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of lead for single complex studies or group of studies. • Manage project budget and resource requirements and provide training/guidance to lower level staff. • Masters degree or educational equivalent in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 4 years relevant experience; or equivalent combination of education, training and experience • Knowledge of statistics and/or clinical drug development process • Knowledge of electronic submissions (including: knowledge of data submission structures and requirements; experience in creating relevant hyperlinks, etc) • Advanced knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities.2012-05-03 04:33:56United StatesQuintilesKansas1205590KSOverland Park, KS28355055http://quintiles.jobs/xml/28355055/jobUSACambridgeTitle: Associate Systems Analyst - Outcome, Cambridge MA Location: USA-Massachusetts-Cambridge Other Locations: Purpose: The Associate Systems Analyst will define technical requirements and create/approve project specifications, while communicating with all departments to facilitate successful project delivery to the client. This individual will create standard and custom EDC project requirement specifications, improve the quality and coverage of technical documentation and manage specification approval process. Primary Responsibilities: § Creates standard and custom EDC project requirement specifications § Improves the quality and coverage of technical documentation § Works with management to identify and prioritize documentation needs § Maintains a rapport with Development, Quality teams and promotes good documentation and communication practices § Manages specification approval process § Acts as a designated contact for documentation improvements for external and internal projects § Maintains the overall structure of the documentation template set Requirements: § Bachelors degree § Great interpersonal and communication skills and the ability to multi-task. § Superior written and verbal communication skills with an ability to write clearly and concisely and a strong attention to technical details § Ability to grasp technical concepts quickly, understanding of Java and web technologies is preferred § Must enjoy the challenges of owning and developing a wide range of documents necessary to support the full development life cycle2012-05-02 04:46:37United StatesQuintilesMassachusetts1205766MACambridge, MA28324793http://quintiles.jobs/xml/28324793/jobUSARockvilleTitle: Stat Programmer 2 Location: USA-Maryland-Rockville Other Locations: USA-Massachusetts-Cambridge Outcome, the late phase division of Quintiles, conducts both US and Global observational studies and Phase IIIb/IV trials in all therapeutic areas. In fact, Quintiles conducts more studies than any other service provider in the world. Become involved in work that improves the quality of life for people around the globe. We are seeking an enthusiastic Statistical Programmer 2 for either our Rockville, MD or Cambridge, MA offices. The Statistical Programmer 2 will provide advanced technical expertise as part of the Statistical Programming (SP) team to develop and maintain programs to meet internal and external clients' needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. RESPONSIBILITIES • Program, plan and co-ordinate: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks. • Program the integration of databases from multiple studies or sources. • Develop and plan programming documentation including plans and specifications, as appropriate. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to the Outcome Biostatistics and Statistical Programming department. • Perform and plan the development, implementation and validation of new process technologies, macros and applications. • Masters degree or educational equivalent in statistics or related field and 1 year relevant experience; Bachelor's degree or educational equivalent in statistics or related field and 2 years relevant experience; or equivalent combination of education, training and experience • Knowledge of statistics and/or clinical drug development process. CRO experience preferred but not required • Knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, communication skills, multi-tasking abilities, and attention to detail.2012-05-02 04:46:23United StatesQuintilesMaryland1206149MDRockville, MD28324789http://quintiles.jobs/xml/28324789/jobUSABrooklynTitle: Pharmaceutical Sales Representative - Pediatric Care Brooklyn, NY 6280 Location: USA-New York-Brooklyn Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:20United StatesQuintilesNew York1206613NYBrooklyn, NY28324788http://quintiles.jobs/xml/28324788/jobUSALexingtonTitle: Pharmaceutical Sales Representative - Pediatric Care Lexington, KY 6280 Location: USA-Kentucky-Lexington Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:20United StatesQuintilesKentucky1206616KYLexington, KY28324787http://quintiles.jobs/xml/28324787/jobUSANashvilleTitle: Pharmaceutical Sales Representative - Pediatric Care Nashville, TN 6280 Location: USA-Tennessee-Nashville Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:20United StatesQuintilesTennessee1206617TNNashville, TN28324786http://quintiles.jobs/xml/28324786/jobUSAPhiladelphiaTitle: Pharmaceutical Sales Representative - Pediatric Care Philadelphia, PA 6280 Location: USA-Pennsylvania-Philadelphia Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:19United StatesQuintilesPennsylvania1206614PAPhiladelphia, PA28324784http://quintiles.jobs/xml/28324784/jobUSAColumbusTitle: Pharmaceutical Sales Representative - Pediatric Care Columbus, OH 6280 Location: USA-Ohio-Columbus Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:19United StatesQuintilesOhio1206615OHColumbus, OH28324785http://quintiles.jobs/xml/28324785/jobUSABirminghamTitle: Pharmaceutical Sales Representative - Pediatric Care Birmingham, AL 6280 Location: USA-Alabama-Birmingham Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:19United StatesQuintilesAlabama1206618ALBirmingham, AL28324783http://quintiles.jobs/xml/28324783/jobUSATampaTitle: Pharmaceutical Sales Representative - Pediatric Care Tampa, FL 6280 Location: USA-Florida-Tampa Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:19United StatesQuintilesFlorida1206619FLTampa, FL28324782http://quintiles.jobs/xml/28324782/jobUSACambridgeTitle: Clinical Project Support Specialist Location: USA-Massachusetts-Cambridge Other Locations: Job location is the Cambridge, MA office - relocation is not offered Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. RESPONSIBILITIES * Establish and maintain all project documentation including all files, records and reports according to the scope of work and SOPS * Take minutes at all department meetings * Reconcile all invoices related to clinical expenses * Assist with periodic review/audit of files for accuracy and completeness * Coordinate and track all information, communications, documents, materials and supplies for assigned projects * Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information * Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing, interpretation of financial figures which may lead to identification of out of scope activities not previously reported * Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices * Prepare presentation materials for meetings (internal/external) and project summary data * Coordinate project team and/or customer meetings including logistics and materials required * Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes * Will serve as primary backup contact for internal project team and for external stakeholders/customers as designated by project manager * Will undertake project management activities as directed by project manager. * Good communication and interpersonal skills * Good problem solving skills * Results and detail-oriented approach to work delivery and output * Good planning, time management and prioritization skills * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's Degree * 1 year's relevant experience; or equivalent combination of education, training and experience.2012-05-02 04:46:18United StatesQuintilesMassachusetts1206176MACambridge, MA28324781http://quintiles.jobs/xml/28324781/jobUSATulsaTitle: Primary Care Sales Representative - Tulsa, OK 7069 Location: USA-Oklahoma-Tulsa Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-02 04:46:16United StatesQuintilesOklahoma1206631OKTulsa, OK28324779http://quintiles.jobs/xml/28324779/jobUSANapervilleTitle: Primary Care Sales Representative - Naperville, IL 7069 Location: USA-Illinois-Naperville Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-02 04:46:16United StatesQuintilesIllinois1206632ILNaperville, IL28324780http://quintiles.jobs/xml/28324780/jobUSAResearch Triangle ParkTitle: Global Pediatric Regulatory Strategy Lead Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta, USA-California-San Diego, USA-New Jersey-Parsippany, USA-Kansas-Overland Park Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seekingGlobal Pediatric Regulatory Strategy Leadto work with our Pediatrics Division. Serve as a Pediatric Therapeutic expert in applying therapeutic knowledge, and regulatory expertise to proposal strategies and drug development opportunities, influencing customers regarding clinical development approaches and decisions. This individual will provide a bridge between operational execution and regulatory strategy for pediatric clinical development activities. The Global Pediatric Regulatory Strategist will have a direct impact on increasing sales and supporting therapeutic differentiation across all Therapeutic Delivery Units (TDU). Serve as a key advisor and partner with the therapeutic operational delivery teams to align strategies and direction to deliver quality results. RESPONSIBILITIES * Provide strategic drug development advice to customers and internal teams * Participate in overall strategic drug development plans and development of clinical protocols by incorporating innovative designs and creating exceptional value * Help drive pediatric strategy, due diligence and business planning for potential partnerships * Provide oversight of the comprehensive drug development process with a special expertise in global regulatory strategy for pediatric use * Assist in authoring Pediatric Investigational Plans for EMA submission * Define, review and sign off proposal strategies and budgets within assigned area. * Lead and/or attend Bid Defense or customer meetings as strategy expert as required. * Partner with key customers as a pediatric clinical trial expert and via governance structures. * Assist with and implement strategic initiatives for business growth. * Design and support protocol-specific and pediatric therapeutic training across the TDU as necessary. * Foster and leverage relationships with Thought Leaders both internal and external to Quintiles. * Attend selected R&D/scientific/clinical public meetings as Quintiles' Therapeutic representative to keep abreast of current trends and developments from a scientific, customer and competitor perspective. * Participate in projects or initiatives as required. * Participate in the selection and hire of TDU staff. Bachelor's degree in life sciences, advanced degree preferred (MD/DO, PhD, MPH, PharmD, etc) with specialization in therapeutic area and 10 years' drug development experience, with 6 years experience in strategic project leadership. * Proven and demonstrable record in leadership of drug development implementation * Deep and current knowledge of scientific, clinical, regulatory and commercial landscape / literature in pediatrics * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines as they relate to pediatrics * Excellent communication and interpersonal skills, including good command of English language * Strong leadership skills with proven ability to lead a virtual team in a matrix structure * Strong innovative capability * Excellent negotiation and influencing skills necessary to sell proposal strategy to customers * Strong strategic thinking ability * Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-05-02 04:46:15United StatesQuintilesNorth Carolina1206366NCResearch Triangle Park, NC28324777http://quintiles.jobs/xml/28324777/jobUSAChattanoogaTitle: Primary Care Sales Representative - Chattanooga, TN 7069 Location: USA-Tennessee-Chattanooga Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-05-02 04:46:15United StatesQuintilesTennessee1206630TNChattanooga, TN28324778http://quintiles.jobs/xml/28324778/jobUSAMemphisTitle: Pharmaceutical Sales Representative - Pediatric Care Memphis, TN 6280 Location: USA-Tennessee-Memphis Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:12United StatesQuintilesTennessee1206621TNMemphis, TN28324776http://quintiles.jobs/xml/28324776/jobUSAWest Palm BeachTitle: Pharmaceutical Sales Representative - Pediatric Care West Palm Beach, FL 6280 Location: USA-Florida-West Palm Beach Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forPharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:11United StatesQuintilesFlorida1206620FLWest Palm Beach, FL28324773http://quintiles.jobs/xml/28324773/jobUSABronxTitle: Flex-Time Pharmaceutical Sales Representative - Pediatric Care Bronx NY/Bridgeport CT 6280 Location: USA-New York-Bronx Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forFlex-TimePharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Flex-Time Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Flex-time Representatives will work a 3 day work week (Mon, Wed, Fri). Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:11United StatesQuintilesNew York1206623NYBronx, NY28324774http://quintiles.jobs/xml/28324774/jobUSACharlotteTitle: Flex-Time Pharmaceutical Sales Representative - Pediatric Care Charlotte, NC 6280 Location: USA-North Carolina-Charlotte Other Locations: WORK WORTH DOING As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forFlex-TimePharmaceutical Sales Representative - Pediatricsto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be working with a global pharmaceutical and biotechnology company that has grown by leveraging two powerful trends impacting the world of medicine - globalization and biotechnology. Flex-Time Pharmaceutical Sales Representative - Pediatrics The Representative targets and promotes cough and cold pediatric care products to Pediatricians. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Flex-time Representatives will work a 3 day work week (Mon, Wed, Fri). Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including car allowance, medical, dental, life insurance and vision coverage, tuition assistant, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE * 4 year Bachelor's degree required * 2 years of Business to Business sales experience required * Proven sales performance over time with ability to show demonstrated success increasing product market share or prescription sales growth * Superior sales, analytical, and organizational skills are essential. * Ability to learn new products and understand pediatric marketplace * Must reside within territory geography * Strong work ethic and customer focus orientation Competencies * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-02 04:46:11United StatesQuintilesNorth Carolina1206624NCCharlotte, NC28324775http://quintiles.jobs/xml/28324775/jobUSAResearch Triangle ParkTitle: Director, Global Strategic Sourcing Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. Quintiles is seeking a Director, Global Strategic Sourcing to join our team in our corporate headquarters in RTP, NC. Incumbent will oversee and direct aspects of Purchasing initiativeseither regionally or globally and across different business functions to realize benefits. Ensure the department adheres to the Quintiles corporate purchasing policy which encourages vendor competition. Experience & Background * Extensive knowledge of leading procurement practices, techniques and innovations across an indirect spend portfolio * Demonstrable success in delivery of significant procurement savings in challenging, international environments * A track record of engaging with C-level business stakeholders to establish and build buy-in for a common vision for procurement capability, and lead the business and functional change required to make this a reality Business Skills & Knowledge * Excellent interpersonal, listening and influencing skills, with the ability to operate successfully in matrix or dual-reporting organizations * Highly commercial, with a proven ability to use procurement to unlock value for the business * Strategic thinker, with the ability to establish and communicate the vision and strategic direction for Group-led procurement * Delivery focused with a pragmatic, hands-on approach * Real business acumen and demonstrably high intellectual capability * The ideal candidate will be from a reputed Fortune 500 multinational company, familiar with working in a matrix structure. RESPONSIBILITIES * Collaborate with senior management and other functional leadership to improve efficiencies for purchasing. Continually look for process improvement, seeking new ideas and ensuring open communication with staff. May participate in or lead corporate or departmental quality or process improvement initiatives. * Contribute to discussions on implementation of purchasing strategy on a regional basis and implement objectives as appropriate. Ensure staff have a consistent understanding and positive impression of business strategy for regional and global objectives. Lead strategic initiatives and develop implementation plans. * Full financial responsibility and accountability for team(s); responsible for monitoring growth and performance. * Provide leadership and management of purchasing projects from conception through deployment. Establish project budgets, resource plans, milestones, tracking metrics, and success measures. * Extract spend data from accounts payable or other databases and prepare spend analysis by category in various formats to highlight potential opportunities. * Extract spend files from vendors to create baselines spend for key purchasing categories. * Identify purchasing programs where change will impact the business, develop implementation plans, lead change teams and regularly liaise with senior management. * Identify and agree with key stakeholders purchasing team membership, purchasing process steps and timetable and ensure stakeholder interests are adequately represented on the team. * Prepare and present purchasing recommendations to management and stakeholders. * Benchmark and validate opportunities by Requests for Information, and prepare and issue competitive Requests for Proposals. * Manage and build relationships with internal stakeholder and senior management to identify purchasing opportunities and programs from business plans. * Create purchasing plans, priorities, change programs and vendor management programs. REQUIRED KNOWLEDGE, SKILLS & ABILITIES Ideal candidate will possess a Bachelor's Degree in business or finance with a minimum of ten years strategic sourcing, supply chain management, materials management, purchasing or procurement experience, including previous line management experience; or equivalent combination of education, training and experience. Incumbent must have: * Strong analytical, business process and problem solving capabilities. * Business and Financial acumen; highly motivated; results oriented. Ability to build cross functional relationships and cross functional understanding. * Well versed with sourcing technologies, auctioning process and reverse auctioning. * Proven negotiation skills and the ability to influence at the highest levels. * Multi cultural with excellent communication and project management skills; must take initiative and follow through on assignments in a timely manner. * In depth knowledge of sourcing methodologies, principles, theories, processes and practices. * In depth knowledge of supply chain management, materials management, purchasing or procurement. * Good working knowledge of MS Office applications. * Knowledge of sourcing indirect vendor spend categories such as IT, telecoms, temporary staff, travel, office equipment, facilities related, outsourced service deals. * Strong analytical, numeracy and line management skills. * Excellent written and verbal communication, negotiation, contracting, interpersonal, conflict resolution, customer service and project management skills. * Ability to lead and motivate cross functional sourcing teams. * Ability to establish and maintain effective working relationships with co-workers, managers, business partners and clients.2012-05-01 04:27:23United StatesQuintilesNorth Carolina1206371NCResearch Triangle Park, NC28289858http://quintiles.jobs/xml/28289858/jobUSAIndianapolisTitle: Semio ETL Developer Location: USA-Indiana-Indianapolis Other Locations: Come see why Quintiles has just been named to Computerworld's 2008, 2009 and 2011 lists of the "100 Best Places to Work in IT". A career at Quintiles Transnational Corp. puts you at the corporate center of the leading worldwide pharmaceutical services organization. If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. Apply now for our Senior Database/ETL Developer position based in Indianapolis, IN. The Senior Database/ETL Developer is a technical, hands-on role. You will be working in the mode of a startup software development house focusing on designing data architectures, schemas and structures including modern web/semantic approaches, to fulfill complex data analysis needs. The Senior Database/ETL Developer will have a strong level of experience in the following: Essential • Enterprise Data Integration across multiple systems with leading EAI and/or ETL tools and OLAP tools. Primarily Microsoft SSIS • Deep experience with XML. • Experience with tools such as XML Spy. • Proven in experience in handling multiple data formats and processing • Development experience with RDMBS database technologies especially sqlserver 2008 • Building of Operational Data Stores (ODS), Data Marts • Data Analysis and Data Model Development (i.e. logical and physical models) Preferred • Master Data Management concepts • Experience with Data Modeling. Experience with Data Modeling tools * Erwin, ER-Studio, Rational The ideal candidate will be a proponent for innovation, best practices, sound design with optimization in mind, strong development habits, and efficient team/project structures. Quintiles Information Technology offers a world class, global organization with ample career development and opportunity. We are seeking change agents that are highly motivated and enthusiastic to join our talented team! • BS degree preferred • Health & Life Sciences experience a plus • A minimum of 5 years relevant technical experience with ETL and Database Development • Solid understanding of service oriented architectures, application frameworks and system integration methods • Must have excellent problem solving skills • Experience with Agile methodologies • Familiarity with emerging technologies and software development best practices • Demonstrated abilities to communicate with both technical and business stakeholders2012-05-01 04:27:16United StatesQuintilesIndiana1205470INIndianapolis, IN28289857http://quintiles.jobs/xml/28289857/jobUSAResearch Triangle ParkTitle: Outcome, Associate Business Performance Analyst Director Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Direct clinical monitoring operations for a designated Quintiles regional office or group to ensure projects are appropriately resourced and employees are trained and developed to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. Manage and direct all aspects of Financial Operations, either regionally or globally, providing direction on financial planning and forecasting. Supervise Sr Clinical Research Associates (CRAs), Clinical Team Leads (CTLs), Clinical Study Managers (CSMs) as directed by senior management. May also supervise Clinical Operations' Managers and/or Associate Managers. PURPOSE * Direct clinical monitoring operations for a designated Quintiles regional office or group to ensure projects are appropriately resourced and employees are trained and developed to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. * Manage and direct all aspects of Financial Operations, either regionally or globally, providing direction on financial planning and forecasting. * Supervise Sr Clinical Research Associates (CRAs), Clinical Team Leads (CTLs), Clinical Study Managers (CSMs) as directed by senior management. May also supervise Clinical Operations' Managers and/or Associate Managers. RESPONSIBILITIES * Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. * Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process. Evaluate current methods and develops office/region based tools for onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. * Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide * oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. * Allocate resources to clinical research projects by assigning staff to clinical studies that are appropriate to their * experience and training. May participate in country/region coordinated resourcing process. * Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. This review may include review of written materials, soliciting internal and external customer feedback, and review of project assignment completion. Identifies quality risks and issues and create appropriate corrective action plans. * Ensure that staff are meeting defined workload, quality and budget metrics through regular review and reporting of * findings as outlined by clinical operations management. * Act as a coach and mentor for CTLs and experienced CRAs as they develop in their role. Collaborate with project * leadership including the PM and other functional leadership to manage project related challenges and to achieve * exemplary customer service. Act as an adjunct clinical team lead as needed to support achievement of study objectives. * Participates in corporate or departmental quality or process improvement initiatives. * May contribute to discussions on implementation of Finance strategy on a regional basis and implement objectives, as appropriate. * Ensure staff have a consistent understanding and positive impression of business strategy for their respective business unit/division/country. * Advise operational leaders on financial, strategic, organizational, and business issues for both short- and long-term growth strategies. * Assist in implementation of management and administrative financial systems, policies, and procedures to provide structure and discipline for sustained business growth. All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines * Knowledge of clinical research financial parameters and project financial tracking and accounting methods * Strong leadership skills * Effective presentation skills * Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint * Strong written and verbal communication skills including good command of English * Excellent organizational and problem solving skills * Effective time management skills and ability to manage competing priorities * Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in a health care or other scientific discipline or educational equivalent; 8 yrs of experience working on clinical trials with 5 years experience in a leadership capacity; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS * Extensive use of telephone and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time * Occasional travel, approximately 30% of work week *2012-05-01 04:27:04United StatesQuintilesNorth Carolina1206491NCResearch Triangle Park, NC28289855http://quintiles.jobs/xml/28289855/jobUSAParsippanyTitle: Director/Senior Director Commercial Business Development (North East/Mid Atlantic Region) Location: USA-New Jersey-Parsippany Other Locations: *This position is located in the North East/Mid Atlantic US* PURPOSE Establish and manage an effective business development program to maximize organization growth. Serve as overall customer relationship manager and strategic business partner responsible for developing and expanding new Commercial business opportunities with customers. RESPONSIBILITIES •Maintain in-depth knowledge of all Quintiles services for appropriate cross-sell opportunities. •Actively prospect and leverage potential new business opportunities within specified potential new and/or existing Customers/Accounts. •Establish and execute a comprehensive sales plan for each target account. •Cultivate strong, long-term relationships with key decision-makers within Account and develop deep knowledge of the customer organization. •Actively network in the industry to establish relationships and to identify potential opportunities. •Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards. •Continuously monitor status of leads and opportunities to ensure a pipeline of opportunities is maintained. •Analyze potential opportunities and develop sales strategies for each customer account. Ensure appropriate strategy/solution is proposed to customer. Monitor actions and results against plans. •Establish brand recognition; communicate with internal Project Managers to assess overall level of customer satisfaction and progress of projects. •Work with operations and functional managers to identify sales team and prepares and leads the sales presentation. Educate team participants in customer culture, operational needs/methods and sales techniques needed to close the sale. •Coordinate with contracts and proposals to develop proposal. •Handle follow-up related to the sale and drive completion of contractual documents. •Utilize CRM to establish reports and dashboards to analyze business development and sales activities and track progress. •Maintain high visibility within customer organization. •Plan and coordinate all customer sales activities. •Communicate all account activity to Senior Sales Leader and/or appropriate individuals through the CRM system. •Lead/participate in change management initiatives for the sales organization. •Provide overall support and serves as a mentor for junior sales staff members. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES •Proven track record at developing mid-level and high-level contacts •Extensive understanding of Sales and Marketing organizations within Healthcare companies •Excellent oral and written communication skills •Strategic business awareness and analytical skills •Adaptability and flexibility to changing priorities •Demonstrated ability to work creatively and effectively in a fast-paced environment •Attention to detail and ability to work simultaneously on multiple priorities •Ability to maintain demanding timelines •Ability to influence others both internally and externally •Ability to work independently and as a team player •Ability to establish and maintain effective working relationships with coworkers, managers and clients ·Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel MINIMUM REQUIRED EDUCATION AND EXPERIENCE •Bachelor's degree in Business Management and 15 years relevant industry experience (Pharmaceutical/Biotech, Medical Device/Consumer); or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS •Use of keyboard requiring repetitive motion of fingers •Extensive use of telephone and face-to-face communication requiring accurate perception of speech •Frequent travel •Frequent long, varied hours2012-05-01 04:27:04United StatesQuintilesNew Jersey1206492NJParsippany, NJ28289856http://quintiles.jobs/xml/28289856/jobUSADurhamTitle: Principal Infrastructure Analyst Location: USA-North Carolina-Durham Other Locations: USA-Kansas-Overland Park PURPOSE Interface closely with Senior Management to develop infrastructure processes that support strategic plans, process improvements, and project justifications. RESPONSIBILITIES • Align process improvement procedures with business processes and Information Technology (IT) methodologies to identify business opportunities that leverage technology, reduce costs, and increase staff productivity. • Heavy internal client service • CMDB governance, configuration, AND maintenance • Assist in the development of business cases and return on investments • Production acceptance testing and validation via Service Now; creation of test cases as needed. • Lead complex projects and provide support to project teams to ensure system requirements are well defined. • Provide leadership necessary to consistently deliver the solutions and processes needed to support business clients effectively. Ensure proactive, timely communication between all parties, including prompt follow up as needed. • Identify opportunities to exploit technologies of systems for competitive advantage for business and technology. • Ensure prompt resolution of IT issues (with regard to IT solutions, services or processes), to prevent problems from recurring. • Implement and maintain IT project management and reporting methodologies consistent with the global IT Strategies and Program Office. • Maintain excellent relationships with site staff, peers, senior management, clients, vendors, customers, and trading partners. • Maintain awareness in developments in computer technology, industry tools and activities, which may require travel to other Quintiles offices or established training centers. • Perform other duties as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Working knowledge of Microsoft server, workstation, and networking activities. • Working knowledge of industry standards in regards to system and network administration with solid understanding of communication systems and devices. • Excellent organizational, consultative and communication skills with strong analytical skills and attention to detail. • Ability to establish and maintain effective working relationships with coworkers, managers and clients. • Must have excellent customer facing skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE - Bachelor's Degree in Computer Science or preferred - 7 years IT experience, including NT servers, phone system management and network environments utilizing PC/Server software2012-05-01 04:27:02United StatesQuintilesNorth Carolina1206587NCDurham, NC28289854http://quintiles.jobs/xml/28289854/jobUSAParsippanyTitle: Sr Biostatistician- Office based or Homebased anywhere in US or Canada Location: USA-New Jersey-Parsippany Other Locations: Canada Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. Quintiles is seeking enthusiastic Senior Biostatisticians to join our GFR Biostatistics team. Position can be Office Based or Homebased anywhere in the United States or Canada. The Senior Biostatistician will develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. RESPONSIBILITIES • Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis. • Perform protocol development, sample size calculation, protocol and CRF review. • Advise data management staff on database design, validation checks and critical data. • Write statistical sections of integrated reports. • Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data). • Fulfill the Lead role for single complex studies or groups of studies. • Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. • Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings. • Manage customer relationships and provide training and guidance to lower level and new staff. • PhD or educational equivalent in biostatistics or related field and 1 year relevant experience; Master's degree or educational equivalent in biostatistics or related field and 3 years relevant experience • Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials • Strong working knowledge of SAS computing package • Familiarity with other statistical computing packages such as S , SUDAAN, StatXact • Pharmaceutical, drug development, biotech or CRO industry experience • Excellent written and oral communication skills including grammatical/technical writing skills • Excellent attention and accuracy with details • Strong individual initiative, organization skills and multi-tasking ability. • Ability to lead and co-ordinate small teams2012-05-01 04:26:52United StatesQuintilesNew Jersey1205899NJParsippany, NJ28289853http://quintiles.jobs/xml/28289853/jobUSAWashingtonTitle: Specialty Sales Representative, Renal - N. Virginia / S. Maryland / Washington DC 7071 Location: USA-District of Columbia-Washington Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Specialty Sales Representatives to join our team of over 7,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Specialty Sales Representative The Specialty Sales Representative targets, promotes and sells prescription products to Nephrologists and general practitioners. The Specialty Sales Representative manages their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. They provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements: * Bachelors degree * Candidates must have a minimum of three to five years of successful field sales experience; pharmaceutical or medical sales * Renal sales experience a plus, previous specialty sales experience highly preferred * Previous and proven sales success, award winners preferred * Superior sales, analytical, and organizational skills are essential. * Must reside within territory geography * Candidates must be in good standing for the previous 2 years with current company * Demonstrated ability to work as a team player Competencies: * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated leadership ability * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-01 04:26:32United StatesQuintilesDistrict Of Columbia1206570DCWashington, DC28289851http://quintiles.jobs/xml/28289851/jobUSAAlbanyTitle: Specialty Sales Representative, Renal - Upstate New York 7071 Location: USA-New York-Albany Other Locations: USA-New York-Syracuse As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Specialty Sales Representatives to join our team of over 7,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. Specialty Sales Representative The Specialty Sales Representative targets, promotes and sells prescription products to Nephrologists and general practitioners. The Specialty Sales Representative manages their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. They provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Requirements: * Bachelors degree * Candidates must have a minimum of three to five years of successful field sales experience; pharmaceutical or medical sales * Renal sales experience a plus, previous specialty sales experience highly preferred * Previous and proven sales success, award winners preferred * Superior sales, analytical, and organizational skills are essential. * Must reside within territory geography * Candidates must be in good standing for the previous 2 years with current company * Demonstrated ability to work as a team player Competencies: * Demonstrated analytical skills * Demonstrated Business Acumen * Demonstrated success in persuasion, influence and negotiation skills * Demonstrated leadership ability * Demonstrated ability to apply technical/scientific knowledge * Flexibility to learn new products over time * Knowledge of and experience with the selling process * Initiative & execution-oriented * Teamwork2012-05-01 04:26:32United StatesQuintilesNew York1206571NYAlbany, NY28289852http://quintiles.jobs/xml/28289852/jobUSAAtlantaTitle: AD, Facilities Location: USA-Georgia-Atlanta Other Locations: The Associate Director of Facilities directs the planning, development and implementation of facilities processes and procedures for multiple Quintiles laboratory locations with budgetary responsibility for all designated sites. The responsibilities of the position include but are not limited to: * Manage facility/space planning/design and construction as assigned * Manage work with landlord on all Facilities issues including contractual obligations * Ensure timely communication to internal customers regarding Facilities Management, services, safety and environmental information. * Establish and support standards (office space, laboratory, furniture, equipment) and supervise adherence to standards by departments and recommend modifications to standards when appropriate. * Regularly interface with Senior Management, Finance and Human Resources to keep up-to-date on new hire projections, status of open requisitions and additional postions that will affect space needs. * Direct and/or work closely with architect/designer to design efficient space usage based on departments requirements; ensure Quintiles quality and standards are adhered to; determine additional furniture/equipment needs. * Research additional options (e.g. noise masking/accoustical panel systems) to enhance working environment for employees. * Assign project work and review workloads for staff utilizing specific skill levels in support of regional areas. * Manage internal customer service levels and establish a best in class customer service attitude within Facilities for customers. Also establish a collaborative and cooperative approach when working with other support groups to provide combined best in class service. * Manage staff in accordance with organization's policies and applicable legislation. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development: rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration. * Other duties assigned by Manager. * Bachelor's degree and 10 years facility management experience with demonstrated ability to exercise proper judgment * Experience within the Lab environment is desired but not required * Professional certification as a Certified Facility Manager is desired but not required * Demonstrated record of project management skills that include coordination of construction with multiple trades, establishment and adherence to budget, code compliance and knowledge, and close out procedures. * Demonstrated ability to read floor plans and proficiency in a CAFM system. * Demonstrated and proven record of providing excellent internal and external customer service * Demonstrated use of customer survey techniques and improving services to customers. * Strong interpersonal skills and problem solving ability * Excellent verbal/written communication and presentation skills * Knowledge of standard business and accounting practices * Proficiency with Excel; PowerPoint, Word is preferred2012-04-28 04:06:07United StatesQuintilesGeorgia1206515GAAtlanta, GA28257413http://quintiles.jobs/xml/28257413/jobUSAIndianapolisTitle: Info COE Developer (SW Engineer / Architect) Location: USA-Indiana-Indianapolis Other Locations: Purpose:Researches and conducts fact finding to develop or modify information systems such as database, code base or application. Prepares detailed specifications for the changes proposed to information systems. Designs, codes, tests, repairs, documents and maintains systems as assigned. Responsibilities: Responsible for designing, building, and testing applications written in the .Net Framework 4.0 using C# following the MVVM, repository, and unit of work patterns. Will develop using Test Driven Development (TDD) methods. Tests will be developed in Visual Studio 2010 test projects. Will also be responsible for database development using T-SQL, MSSQL scripts and SSIS packages and transforms. Will interface with other developers and provide database structural assistance and guidance. Will ensure the assigned development team produces stored procedures and scripts that follow the team's standards. Will work in a collegial culture that values autonomy, ownership, and flexibility on a daily basis - expected to work in an agile environment. Will estimate the magnitude and time requirements of a given task. Requirements: Should be able to articulate a solid understanding of: · .Net Framework 3.5 using C# on Visual Studio 2008. · Developing Windows forms or WPF applications and use of third party tools such as Xceed grid. · Software development patterns, MVC and Repository. · MSSQL T-SQL language. · MSSQL scripting or in depth knowledge of SQL Server Management Studio (SSMS). · MSSQL SSIS package and transforms using Visual Studio 2008. · Prefer a bachelor's degree in Computer Science or equivalent work experience. · Strong interpersonal skills. Strong verbal and written communication skills with an ability to translate technical concepts as appropriate to the level of the audience. · Ability to work self-directed and as part of a team on projects of varying size; shows commitment to tasks, project, and to team. At Semio Clinical you will be challenged to keep up with some the top developers in the country using WPF. We use MVVM, repository and Unit of work patterns extensively. We build using Test Driven Development in a truly agile environment. In addition, you will have database and back end responsibilities, a renaissance coder for the next generation of software development. We have built the next generation software for the medical industry in less than three years. The software was used by the end of the first sprint to make critical decisions. Come join a team that is making a difference. Come and be challenged intellectually. We stretch the cutting edge. We are the burning edge.2012-04-28 04:06:07United StatesQuintilesIndiana1206526INIndianapolis, IN28257414http://quintiles.jobs/xml/28257414/jobUSAResearch Triangle ParkTitle: Associate Director, Clinical Project Management (Late Phase) Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Manage the execution of the assigned multi- regionalstudy(ies), which may include study management, clinical and other functions per Contract, from initiation through to closeout.Ensure that all study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES ?Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects. ? Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to. ? Define, develop and implement study management plans, together with team assignments and accountabilities. ? Supervise team performance against contract, customer expectations, and project baselines. Develop recommendations for issue resolution for management and Sponsors. ? Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate clinical risk. ? Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings and own the implementation of appropriate corrective action plans. Manage and oversee the escalation of findings and action plans to appropriate parties. ? Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles. Ensure that Sponsor feedback is communicated and conveyed to other functional groups and action is initiated to address. ? Participate in proposal development, influence the scope and budget development of proposals for new work, including the study management costs. Escalate out of scope requests to management. ? Provide input to line managers of their project team members' performance relative to project tasks. Recommend team members' further professional development. Support staff development. Mentor less experienced CPMs. ? Prepare and present project information at internal and external meetings. Lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff. ? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines · In depth therapeutic and protocol knowledge · Excellent communication and interpersonal skills, including good command of English language · Excellent organizational and problem solving skills · Track record of ability to work through others to deliver results to the appropriate quality and timeline metrics · Good team leadership skills · Effective mentoring and training skills · Excellent customer service skills · Good judgment · Effective presentation skills · Ability to manage competing priorities · Demonstrated ability in project financial tracking and accounting methods and skill in applying them · Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management · Strong software and computer skills, including MS Office applications · Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 10 years' clinical research experience including 6 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS · Extensive use of keyboard requiring repetitive motion of fingers. · Extensive use of telephone and face-to-face communication requiring accurate perception of speech. · Regular sitting for extended periods of time. · May require occasional travel.2012-04-28 04:05:59United StatesQuintilesNorth Carolina1206431NCResearch Triangle Park, NC28257412http://quintiles.jobs/xml/28257412/jobUSANoneTitle: Clinical Research Associate / CRA / Sr. CRA - South Central Region Location: USA-Texas Other Locations: USA-Oklahoma Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for the South Central region! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - BS/BA required. -2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Cardiology and medical device experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-27 04:11:25United StatesQuintilesTexas1206413TXTexas, USA28226265http://quintiles.jobs/xml/28226265/jobUSAPomonaTitle: Primary Care Sales Representative - Pomona, CA 7069 Location: USA-California Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-04-27 04:10:37United StatesQuintilesCalifornia1206439CAPomona, CA28226262http://quintiles.jobs/xml/28226262/jobUSASan JoseTitle: Primary Care Sales Representative - San Jose, CA 7069 Location: USA-California-San Jose Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-04-27 04:10:37United StatesQuintilesCalifornia1206440CASan Jose, CA28226261http://quintiles.jobs/xml/28226261/jobUSAAtlantaTitle: Primary Care Sales Representative - Atlanta, GA 7069 Location: USA-Georgia-Atlanta Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-04-27 04:10:36United StatesQuintilesGeorgia1206442GAAtlanta, GA28226259http://quintiles.jobs/xml/28226259/jobUSABrooklynTitle: Cardiovascular Care Specialist - Brooklyn, NY 7069 Location: USA-New York-Brooklyn Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Specialty Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Specifications for Cardiovascular Care Cardiology/Endocrinology Specialist: * Professionalism and ethics are a must; as a Cardiovascular Care Specialist you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Cardiovascular Care Specialist, you will be making selling presentations to physicians and other health care professionals, in an office based, Cath lab or hospital setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Specialists are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Specialist maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Specialists participate in and are required to complete initial and ongoing product and development training. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience * 4 year Bachelor's degree from an accredited University required * 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * 18 months prior experience promoting cardiology products to Cardiologists and Endocrinologists is preferred. * Strong scientific/clinical acumen required * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-04-27 04:10:36United StatesQuintilesNew York1206448NYBrooklyn, NY28226257http://quintiles.jobs/xml/28226257/jobUSARaleighTitle: Clinical Research Associate / CRA / Sr CRA / South East - Cardio/Device ~ Location: USA-North Carolina-Raleigh Other Locations: USA-Georgia-Atlanta Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Minimum required BS/BA. - 3 years monitoring experience of on-site monitoring experience. - Cardio and/or Device experience required - Ability to perform regionalized travel an average of 65%, depending on project needs. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-26 04:20:02United StatesQuintilesNorth Carolina1206338NCRaleigh, NC28198442http://quintiles.jobs/xml/28198442/jobUSAOverland ParkTitle: Clinical Research Associate/ Sr CRA (Cardiology/ medical device) Midwest Region Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in cardiology device trials Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. RESPONSIBILITIES Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. Act as a mentor for clinical staff including conducting co-monitoring and training visits. May provide assistance to the CTL with design of study tools, documents and processes. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Therapeutic requirements: Cardiology and medical device experience preferred. Experience requirements: Minimum 2-4 years experience in clinical/scientific research, or medical device/pharmaceutical trial experience. Bachelors Degree in Science or Healthcare Related Field required. In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines In depth therapeutic and protocol knowledge as provided in company training Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer Strong written and verbal communication skills including good command of English language Excellent organizational and problem-solving skills Effective time management skills Ability to manage competing priorities Effective mentoring and training skills Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-04-26 04:19:57United StatesQuintilesKansas1206355KSOverland Park, KS28198441http://quintiles.jobs/xml/28198441/jobUSAResearch Triangle ParkTitle: (ITLS) Subject Matter Expert, Pharmacovigilance, Associate Director or Director Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles Information Technology Unit is completing the implementation of a global adverse event processing and analysis platform. This platform has been designed to support operations and services for more than 50 clients worldwide with access by several hundred lifecycle safety associates and management located on 4 continents. As adoption of the platform increases, our Global IT team will expand to support platform enhancements, operations for internal Quintiles resources, as well as, many collaboration partners accessing the platform from outside. We are seeking people with experience in technical areas along with knowledge of drug safety solutions and process to join our team. PURPOSE Serve as Pharmacovigilance subject matter expert to the IT Safety Platform team and customers. Establish, direct and drive business process efficiencies and standards across the safety platform through stakeholder collaboration while assuring alignment with Standard Operating Procedures. With limited guidance provide expertise, support and advise to IT teams, customers and support structures locally, regionally and globally in the area of Pharmacovigilance and the safety system application. Serve on development teams and share best practices as required. Participate or lead IT customer workshops designed to identify customer requirements, drive best practices and assure standard system implementation. Serve as a customer lead for system as a service (SaaS) programs. RESPONSIBILITIES · Serve as a customer lead for SaaS programs to include but not limited to assuring client and team communications, establishing program direction and leading the implementation team · Serve as an expert to review and improve best practices and establish and maintain safety platform SOPs · Work with global customer base and development team to establish development priorities · Assume a leadership role with all stakeholders to ensure the process systems operate effectively. · Determine, assess and identify global training needs in collaboration with Training function. · Participate in change management functions. · Ensure process system development/deployments adhere to internal and regulatory standards and are developed/deployed in accordance to business expectations . · Participate or lead ITcustomer workshops designed to identify customer requirements, drive best practices and assure standard system implementation. · Participate in business development, marketing and sales activities. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Sound knowledge of LS clinical trial and post-marketing programs. · In-dept knowledge of project management processes with strong understanding of systems and quality functions · Strong project management and leadership skills · Strong written and oral communication; organizational and interpersonal skills · Strong listening and diagnostic skills · Strong problem solving skill in complex situations · Ability to prioritize, organize multiple competing priorities · Strong presentation skills · Strong judgement/decision making · Ability to lead projects effectively within strict deadlines · Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Highly Prefer a Bachelor's degree or educational equivalent in health science or related area · 8 years research experience in a Contract Research Organization or pharmaceutical company · 4 years management experience2012-04-26 04:19:49United StatesQuintilesNorth Carolina1205463NCResearch Triangle Park, NC28198439http://quintiles.jobs/xml/28198439/jobUSAChicagoTitle: Nurse Educator, Neurology - Central US, Major Metropolitan Areas - 4558 Location: USA-Illinois-Chicago Other Locations: USA-Texas-Houston, USA-Alabama-Birmingham, USA-Minnesota-Minneapolis, USA-Missouri-Saint Louis, USA-Texas-Dallas Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 50 Health Management Services teams, and hired more than 1000 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our employee's interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Nurse Educator is a field -based healthcare professional, representing a major Pharmaceutical company, who is responsible for providing education, training, clinical in-services, and information to Neurology offices. The Nurse Educator will facilitate, organize, and deliver education on the product for health care staff and facilitate roundtable discussion groups with nurses and physicians, on various topics related to the product. Education will be done through presentations and workshops. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com/careers. Equal Opportunity Employer Qualifications: * Registered Nurse (RN) license required. * Bachelor's degree or extensive industry/clinical experience required. * Nurse Practitioner preferred. * Neurology and/or Parkinson's experience required. * Industry experience helpful. * Nurse educator experience preferred. * Current license in good standing, willingness to travel. * Good presentation and communication skills required. * Enthusiastic, good attitude and ability to motivate others.2012-04-26 04:19:03United StatesQuintilesIllinois1206365ILChicago, IL28198435http://quintiles.jobs/xml/28198435/jobUSADenverTitle: Nurse Educator, Neurology - Rocky Mountain US, Major Metropolitan Areas - 4558 Location: USA-Colorado-Denver Other Locations: USA-New Mexico-Albuquerque, USA-Arizona-Phoenix Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 50 Health Management Services teams, and hired more than 1000 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our employee's interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Nurse Educator is a field -based healthcare professional, representing a major Pharmaceutical company, who is responsible for providing education, training, clinical in-services, and information to Neurology offices. The Nurse Educator will facilitate, organize, and deliver education on the product for health care staff and facilitate roundtable discussion groups with nurses and physicians, on various topics related to the product. Education will be done through presentations and workshops. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com/careers. Equal Opportunity Employer Qualifications: * Registered Nurse (RN) license required. * Bachelor's degree or extensive industry/clinical experience required. * Nurse Practitioner preferred. * Neurology and/or Parkinson's experience required. * Industry experience helpful. * Nurse educator experience preferred. * Current license in good standing, willingness to travel. * Good presentation and communication skills required. * Enthusiastic, good attitude and ability to motivate others.2012-04-26 04:19:03United StatesQuintilesColorado1206367CODenver, CO28198436http://quintiles.jobs/xml/28198436/jobUSALos AngelesTitle: Nurse Educator, Neurology - Pacific US, Major Metropolitan Areas - 4558 Location: USA-California-Los Angeles Other Locations: USA-Nevada-Las Vegas, USA-California-San Diego, USA-California-San Francisco, USA-Washington-Seattle Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 50 Health Management Services teams, and hired more than 1000 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our employee's interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Nurse Educator is a field -based healthcare professional, representing a major Pharmaceutical company, who is responsible for providing education, training, clinical in-services, and information to Neurology offices. The Nurse Educator will facilitate, organize, and deliver education on the product for health care staff and facilitate roundtable discussion groups with nurses and physicians, on various topics related to the product. Education will be done through presentations and workshops. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com/careers. Equal Opportunity Employer Qualifications: * Registered Nurse (RN) license required. * Bachelor's degree or extensive industry/clinical experience required. * Nurse Practitioner preferred. * Neurology and/or Parkinson's experience required. * Industry experience helpful. * Nurse educator experience preferred. * Current license in good standing, willingness to travel. * Good presentation and communication skills required. * Enthusiastic, good attitude and ability to motivate others.2012-04-26 04:19:02United StatesQuintilesCalifornia1206368CALos Angeles, CA28198434http://quintiles.jobs/xml/28198434/jobUSANew York CityTitle: Nurse Educator, Neurology - Eastern US, Major Metropolitan Areas - 4558 Location: USA-New York-New York City Other Locations: USA-Georgia-Atlanta, USA-Pennsylvania-Philadelphia, USA-District of Columbia-Washington, USA-Massachusetts-Boston Quintiles is a leading commercial solutions provider that offers service solutions designed to accelerate the success of pharmaceutical, biotechnology and medical device products. Since 1997, Quintiles has built more than 50 Health Management Services teams, and hired more than 1000 clinicians. Quintiles Health Management Services is redefining how pharmaceutical and biotech companies can provide caregivers with programs that benefit patients. Our employee's interact with health care professionals to improve treatment adoption in a variety of disease states that are frequently under-diagnosed, misdiagnosed, or under-treated. The Nurse Educator is a field -based healthcare professional, representing a major Pharmaceutical company, who is responsible for providing education, training, clinical in-services, and information to Neurology offices. The Nurse Educator will facilitate, organize, and deliver education on the product for health care staff and facilitate roundtable discussion groups with nurses and physicians, on various topics related to the product. Education will be done through presentations and workshops. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com/careers. Equal Opportunity Employer Qualifications: * Registered Nurse (RN) license required. * Bachelor's degree or extensive industry/clinical experience required. * Nurse Practitioner preferred. * Neurology and/or Parkinson's experience required. * Industry experience helpful. * Nurse educator experience preferred. * Current license in good standing, willingness to travel. * Good presentation and communication skills required. * Enthusiastic, good attitude and ability to motivate others.2012-04-26 04:18:59United StatesQuintilesNew York1206360NYNew York City, NY28198433http://quintiles.jobs/xml/28198433/jobUSAManassasTitle: Scientist 2, Immuno Assay Location: USA-Virginia-Manassas Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 23,000 engaged professionals in over 60 countries are committed to making people healthier. Join us as we define TheNewHealth. We are currently seeking for a Scientist 2 to join our Immunoassay Services team in Manassas, Virginia. PURPOSE The Scientist 2, Immunoassay will perform a variety of technical procedures including serological and cell-based and other Immunoassay development, validation and sample analysis as team member or functioning as the project leader in accordance with Good Laboratory Practice. Responsible for making and recording experimental observations, data analysis and peer review of data. Perform assays according to novel and established test procedures. Prepare lab reagents, participate in maintaining lab equipment and samples, and support lab safety. RESPONSIBILITIES · Execution of cell-based assays, ELISAs, RIAs, and other immunoassay techniques as required in a BSL2 lab. · Learn and perform required laboratory techniques using novel and established protocols and Standard Operation Procedures acting as team member under the direction of project leader or in role of project leader. · Responsible for production and maintenance of cell lines and cell/tissue culture in cellular immunology lab. · Responsible for method development, method validation and sample analysis with minimal assistance, as team member or project leader. · May act as project manager depending on experience. · Perform sample accessioning/handling according to SOP using LIMS system as needed. · Perform data analysis, upload run data/results to LIMS system as needed. · Responsible for the preparation of stock and working solutions/standards and QC samples as needed. · Aliquot standards, controls, control matrices and other reagents, as required. · Dispense proprietary/commercial compounds for the preparation of reference material and assay reagents as needed. · Responsible for the documentation of all project work in appropriate laboratory notebooks according to Advion and GLP procedures and processes. · Prepare and review run binders, notebooks and other project-related documentation. Prepare study worksheets and methodsas project leader or team member as needed.. · Initiate changes in Standard Operating Procedure for modifications of existing processes or preparation of new procedures. · Ability to work a flexible schedule and adapt efficiently to program changes. · Production of quality data and documentation in adherence to timelines and maintenance of GLP functions in the lab. · Order and stock laboratory supplies if needed. · Maintenance of laboratory instrumentation and systems as required. · Monitor laboratory systems as needed · Routine safety inspections as needed · Maintain personal training file and assists in training of other technical staff The successful candidate must have a Bachelor's Degree in Chemistry or a related field with 3 years' progressively responsible related experience; or equivalent combination of education, training and experience in GLP laboratory environment.2012-04-25 04:45:35United StatesQuintilesVirginia1206220VAManassas, VA28167782http://quintiles.jobs/xml/28167782/jobUSAIthacaTitle: Project Leader 2, Bioanalytical Services Location: USA-New York-Ithaca Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 23,000 engaged professionals in over 60 countries are committed to making people healthier. Join us as we define TheNewHealth. We are currently seeking for a BioServices Project Leader 2 to join our team in Ithaca, New York. PURPOSE The BioServices Project Leader 2 will focus on the internal execution of day to day project work. The BioServices Project Leader 2 will work closely with the BioServices Project Manager and ensures that all work stays on schedule and is done according to Advion's standards, with minimal oversight. RESPONSIBILITIES · Plan day to day activities for assigned projects. · Create work lists for wet lab & LC/MS staff. · Request samples from Laboratory Operations for analysis. · Provide daily direction and feedback to Wet Lab/Mass Spectrometry staff. · Set up studies within Watson · Import and process run data in Watson. · Accept or reject run results. · Work with Project Manager to investigate failed runs and runs with analytical issues. · Provides updates to external clients in Project Manager's absence · Write up analytical results and assemble run binders. · Submit accurate weekly assessment of resource requirements for scheduling purposes · Attend weekly scheduling and revenue update meetings and provide updates on project progress. · Maintain run trackers for assigned projects. · Provide timely MS timesheets for study tracking · Review data (run binders, data tables, etc) for regulatory compliance and scientific quality. · Track supply and expiration of project related materials (LC columns, reference compounds, stock solutions, etc). · Assemble data tablesfor client submission. · Design validation experiments to direct wet lab staff. · Archive all studies in a timely manner in accordance with Advion SOP. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Understanding of liquid chromatography and combination with mass spectrometry. · Experienced in sample extraction and routine laboratory procedures. · Understanding of method development and validation of assays · Ability to interact with internal and external clients, and work to objectives/timelines · Excellent attention to detail and communication skills · Ability to follow verbally communicated without further input · Good working knowledge of Watson LIMS · Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's Degree in a scientific field with 3 years' related experience; or equivalent combination of education, training and experience in GLP laboratory environment.2012-04-25 04:45:34United StatesQuintilesNew York1206218NYIthaca, NY28167781http://quintiles.jobs/xml/28167781/jobUSAResearch Triangle ParkTitle: Sr Strategic Biostatistics Dir Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Provide strategic biostatistical input, to high priority sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of success for drugs under development by biotech clients and certain mid-size pharmaceutical companies. Provide strategic biostatistical input at the study level (and across the whole Phase III program) for one or more pharma companies with whom Quintiles has entered into a partnership, with key focus onvery large programs, for which strategic biostatistical input aims to help win further high value business, or help retain existing business. Provide strategic biostatistical support for to increase revenue & operating income by increasing chance of approval (or decreasing time to approval) for compounds in which the Company has invested. Provide strategic biostatistical input to the Due Diligence assessment of compounds in which a moderate size investment is being considered, and contribute to the biostatistical assessment for large investments. Carry out developments in areas of statistical design or analysis that can be used to give Quintiles a greater edge over competing CROs, and so ultimately help us to win more business. Represent clients at FDA or EMEA meetings. RESPONSIBILITIES •Provide strategic biostatistical input at the study level or across Phase III programs (and in some cases provide input on general drug development) to high value sales opportunities to help increase revenue for Quintiles. •Provide strategic biostatistical input at the study level or across Phase III programs (and in some cases provide input on general drug development) to those companies currently working in partnership with Quintiles, with the aim of helping retain existing business and winning further business; as well as provide such input for other key projects where this can lead to large awards in the future. Represent such clients at meetings with FDA and European regulatory authorities. •Provide the biostatistical component of Due Diligence (DD) assessments of compounds for moderate value opportunities, and contribute to high value cases, for which investment is being considered, and provide strategic biostatistical support across Phase III programs in cases where investment has already been made. •Maintain knowledge and awareness of developments in biostatistics, clinical trial methodology, and regulatory requirements that impact on design or analyses for multiple therapeutic areas. Carry out new developments in areas of statistical design or analysis carried out by the Strategic Biostatistics Unit that can be used to give Quintiles a greater edge over competing CROs. •Market Quintiles strategic biostatistical expertise, may include:(i) publishing papers (where advantageous to Quintiles) that demonstrate strategic bios expertise in key areas (such as adaptive design); (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business; and (iv) contribute to publicizing internally to key groups. •May oversee and participate in the provision of training within Global Biostatistics on advanced statistical topics or advanced case studies. May oversee and participate in the provision of high level statistical consultancy provided to Quintiles' Biostatics staff. •May provide mentoring to some other members of SB Unit (on provision of strategic bios input, as well as on technical matters). Where applicable, may attend Global Bios meetings and global bios world-wide calls. All responsibilities are essential job functions unless noted as nonessential (N). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES •Extensive and moderately in-depth knowledge of many of those complex statistical analysis methods that apply to Phase II-IIIB clinical trials, which can be used to cut time, cut costs, and/or increase chance of success •Good overview knowledge of many of the new and cutting-edge design approaches (including many types of adaptive designs) that can beneficially be applied to Phase II-IIIB clinical trials •Ability to develop new methods to cut costs, decrease time, or increase chance of success for drugs under development •Moderately high level of Knowledge of current FDA or EMEA regulatory requirements with respect to study designs, primary endpoints, and acceptable analyses for multiple therapeutic areas •Good understanding of the clinical drug development process •High level knowledge of SAS •Excellent written and oral communication skills •Strong negotiating skills •Ability to operate simultaneously across numerous projects, for many of which the ability to operate in a SWAT type mode is required •Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE •PhD or educational equivalent in biostatistics or related field and 8 years relevant experience; or Masters degree or educational equivalent in biostatistics or related field and 12 years relevant experience;or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS •Extensive use of telephone and face-to-face communication requiring accurate perception of speech •Extensive use of keyboard requiring repetitive motion of fingers •Regular sitting for extended periods of time •Occasional travel2012-04-25 04:45:27United StatesQuintilesNorth Carolina1206305NCResearch Triangle Park, NC28167779http://quintiles.jobs/xml/28167779/jobUSACambridgeTitle: Executive Administrative Assistant 2 (located in Cambridge, MA) Location: USA-Massachusetts-Cambridge Other Locations: **This position is located in Cambridge, MA** PURPOSE Perform diverse administrative duties for head of Line of Business or member of the Policy Management Committee with broad business responsibilities on a global basis or major region(s) of the world necessitating high level contact and exposure to highly confidential information requiring considerable use of tact, diplomacy, discretion, and judgment. Professionally represents the Executive Office to internal and external clients. RESPONSIBILITIES • Schedule appointments as determined by priority. • Prepare and compose correspondence and reports. • Maintain all files including training records. • Coordinate travel schedules, arrange meetings and teleconferences. • Responsible for preparation and timely submission of expense reports as requested by management. • Filter all telephone calls, mail and email; dispersing and handling as appropriate. • Receive, photocopy, distribute, and file a variety of incoming and outgoing correspondence and reports. • Responsible for all incoming and outgoing mail and correspondence including but not limited to faxes, courier deliveries, etc. • Taking and distribute internal meeting minutes. • Coordinate business meetings involving internal or external clients or departmental meetings. • Ensure that communications from the Executive's office to business unit heads are promptly and accurately dispatched. • Support management in recruiting process and new employee departmental set up and orientation. • Produce and maintain process flow charts and organizational charts for department. • Submit staff expense reports in a timely manner. • Maintain database to track appropriate departmental information. • Serve on projects as directed by management. • Serve as an information source for executive, answering questions, making referrals as required, and conducting required research. • Participate in the planning, coordination, and preparation of major business meetings, luncheons, and dinners involving both internal and external clients, departments and companies (including attendance at off-site study specific meetings as required). • Gather data, analyze and prepare reports including conclusions and recommendations for solutions. • Undertake projects, research data and make special studies, requiring independent decisions and conclusions. • Serve as liaison between others and the Line of Business executive, ensuring appropriate management awareness and involvement in decision making process. • Function as IT contact and coordinate maintenance and upgrading of hardware/software systems within specific unit. • Responsible for P-Card activities including but not limited to the ordering of supplies and submitting Visa statements in a timely manner. • Develop and design improved administrative procedures to promote the timely processing and submission of all administrative deliverables. • Coordinate and plan facility needs (space, equipment, etc). • Develop and implement an efficient work flow and information tracking/retrieval system across all assigned projects, and maintains/archives files and records. • When manager is on travel or out of office take the initiative to review, prioritize and make decisions as to what is routine and critical correspondence and email. Respond to routine items and forward urgent issues to appropriate individuals. • Perform other duties as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Excellent computer skills (MS Office Suite, MS Word, MS PowerPoint, MS Access, MS Outlook, and Internet). • Excellent communication skills (written and verbal). • Ability to work both within a team environment and independently to prioritize tasks. • Ability to maintain demanding timelines. • Ability to work independently and manage time efficiently. • Ability to be self-directed, prioritize opportunities and perform multiple tasks. • Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE • High School degree with 5 years related experience; or equivalent combination of education, training and experience.2012-04-25 04:44:37United StatesQuintilesMassachusetts1206291MACambridge, MA28167777http://quintiles.jobs/xml/28167777/jobUSANew OrleansTitle: Clinical Research Associate / Sr CRA /New Orleans, LA - Neuro/ Diabetes ~ Location: USA-Louisiana-New Orleans Other Locations: USA-North Carolina-Research Triangle Park Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-24 05:08:53United StatesQuintilesLouisiana1206235LANew Orleans, LA28094185http://quintiles.jobs/xml/28094185/jobUSACambridgeTitle: Site Management Associate Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose: The Site Management Associate at Outcome remotely supports physicians, nurses, pharmacists, research coordinators and other healthcare workers in use of the company's internet-based tools (EDC) and in all aspects of post-marketing registry management through phone and email support. Provides in-house support to CRA Is, CRA IIs and contract CRAs. Follows established SOPs, GCP (when applicable) and other applicable regulatory requirements in the execution of all activities. Proactively identifies and escalates or resolves operational project issues and participates in process improvement initiatives as required. Primary Responsibilities: • Serve as primary contact for all site interactions (phone and email support) involving the company's EDC by providing basic administrative support (password reset, account set-up) and study-related support (query resolution, data entry, EDC system functionality); documents communication with sites in a timely manner; may include up to 80% of time spent providing phone support • Perform comprehensive trainings on the company's EDC for sites (web based trainings) and internally to the team • Assists and support study start-up activities (i.e., site recruitment, regulatory document collection, IRB submission) including the review of clinical and project-related documents (i.e. protocol, case report form, Informed Consent, monitoring plan, site recruitment plan, source documents, training manuals, study binders, patient contact material, etc.) • Conduct patient outreach activities (inbound and outbound calls) in order to complete or facilitate patients' completion of registry questionnaires • Utilize internal databases to track and manage site/client contacts, patient enrollment, and other registry-specific reports, and provide reports to Project Management/CRAs/client in a timely manner • Investigate, track, prioritize, and resolve site/client user feedback, complaints and issues. Has the ability to recognize and escalate issues where appropriate and choose appropriate method of communication • Provide administrative support by preparing, organizing, managing, and tracking registry supplies such as, but not limited to: patient questionnaire mailings, patient gift cards, study manuals, collecting, filing and tracking regulatory documents • Prepare and disseminate registry correspondence and assist with the creation of registry-specific manuals, tools and templates • Ability to prepare appropriate, timely and accurate communication to internal and external registry teams, consultants and investigative site personnel. • Act as site liaison to CRAs/Project Managers • May be expected to lead site management activities for a study: oversee, train and coordinate participating sites • May perform other duties as applicable Requirements: • Bachelor's degree, preferably in a health or life science concentration • Proficiency in Spanish or Portugese is required • 6 months - 1 year of clinical research experience, study coordinator, data management preferred, but not required • Must be detail oriented, enthusiastic, self-motivated, eager, and have a strong customer service sensibility • Ability to handle multiple tasks and work on multiple project teams simultaneously • Strong organizational skills and self-motivated with the ability to work independently or as part of a team • Excellent verbal, written communication and interpersonal skills • Must be proficient in Microsoft Office • Must have professional demeanor • Understanding of GCPs and knowledge of regulatory requires, but not required2012-04-24 05:08:53United StatesQuintilesMassachusetts1206236MACambridge, MA28094184http://quintiles.jobs/xml/28094184/jobUSACambridgeTitle: Clinical Project Support Specialist / Sr Clinical Project Support Specialist Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. PURPOSE Provide project related support and assistance for assigned regionally-based project(s) and project teams. Will ensure all work is conducted in accordance with SOPs, policies, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. RESPONSIBILITIES · Establish and maintain all project documentation including all files, records and reports according to the scope of work and SOPS · Conduct periodic review/audit of files for accuracy and completeness · Coordinate and track all information, communications, documents, materials and supplies for assigned projects across the region · Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information. Act as internal primary contact for project systems and tools · Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices · Prepare presentation materials for meetings (internal/external) and project summary data · Prepare and present project information at internal and external meetings · Coordinate project team and/or customer meetings including logistics and materials required · Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes · Will serve as primary backup contact for internal project team and for external stakeholders/customers as designated by project manager · Will undertake project management activities as directed by project manager · Train and mentor more junior project support staff, may coordinate their work REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Good communication and interpersonal skills · Good problem solving skills · Strong planning and organizational skills · Ability to handle conflicting priorities · Results and detail-oriented approach to work delivery and output · Excellent customer service skills · Strong software and computer skills, including MS Office applications · Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's Degree and 3 years' relevant experience; or equivalent combination of education, training and experience2012-04-24 05:08:52United StatesQuintilesMassachusetts1206238MACambridge, MA28094183http://quintiles.jobs/xml/28094183/jobUSAResearch Triangle ParkTitle: Manager/Associate Director, Business Development Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Kansas, USA-Indiana-Indianapolis Candidate must reside in RTP, NC; Indianapolis, IN; or Overland Park, KS PURPOSE Secure and retain business through professional, consultative, proactive sales activities directed at decision-makers and decision influencers at existing and new clinical sponsors. RESPONSIBILITIES · Actively prospect and leverage potential new business opportunities within specified customer account(s). · Cultivate strong, long-term relationships with key decision-makers within Account and develop in-depth knowledge of the customer organization. · Maintain general knowledge of all Quintiles services for appropriate cross-sell opportunities. · Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards. · Analyze potential opportunities and develop sales plans for each target account. Ensure appropriate strategy/solution is proposed to customer. Monitor actions and results against plans. · Coordinate with contracts and proposals to develop proposal. · Work with operations and functional managers to identify sales team and prepares and leads the sales presentation. Educate team participants in customer culture, operational needs/methods and sales techniques needed to close the sale. · Handle follow-up related to the sale and drive completion of contractual documents. · Adapt successful strategies and tactics to meet market demands and financial targets. · Maintain high visibility within customer organization. Monitor customer satisfaction by communicating regularly with customer · Plan and coordinate all customer sales activities. · Record all customer sales related activities in CRM system. · Prepare sales activity report for Sales Management as required. · Serve as a liaison between the customer and technical and operational groups at Quintiles, Inc. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Proven track record at mid-level and high-level contacts. · Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business · Solid understanding of commercialization and the principles of drug discovery and development · Excellent analytical skills in assessing and interpreting customer business data · Ability to maintain demanding timelines · Ability to influence others internally and externally · Adaptability and flexibility to changing priorities · Demonstrated ability to work creatively in a fast-paced environment · Attention to detail and ability to work simultaneously on multiple priorities · Ability to work independently and as a team player · Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel · Excellent oral and written communication skills · Ability to establish and maintain effective working relationships with coworkers, managers and customers MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree in Business Management and 3-5 years of relevant industry (CRO/Pharmaceutical) and/or sales experience; or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS · Use of keyboard requiring repetitive motion of fingers · Extensive use of telephone and face-to-face communication requiring accurate perception of speech · Frequent travel · Frequent long, varied hours2012-04-21 05:45:10United StatesQuintilesNorth Carolina1205704NCResearch Triangle Park, NC28055411http://quintiles.jobs/xml/28055411/jobUSAResearch Triangle ParkTitle: Associate General Counsel - Contracts Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. We are currently seeking an Associate General Counsel to join our team at our global headquarters in RTP/Durham, NC. Incumbent will: * Provide counsel in one or more of the following areas: contract law, employment law, commercial law, regulatory and compliance. * Lead strategic initiatives work with other functional management to develop implementation plans. * Supervise less experienced managers as directed by senior management. * Lead and manage the coordination of legal activities with responsibility for results, including costs, methods, and staffing. * This role will be specifically focused on negotiating complex strategic agreements/contracts with ongoing customers. * The Associate General Counsel will work with Quintiles executives to understand what their needs are and to work with customers to get the deal done. This group focuses primarily on supporting our US Clinical business. RESPONSIBILITIES The responsibilities of the role will include some or all of the following: • Manage staff with responsibility for planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters in accordance with organization's policies and applicable regulation. • Review, draft and negotiate a broad range of commercial contracts. Ensure that contracts are in compliance with legal, regulatory and organization policies. Monitor the contract process to assure compliance with the organization's contractual guidelines, satisfaction of customers/vendors, including participation in precontract discussions, contract negotiations and contract changes. • May provide legal advice regarding employment law. Liaise with Human Resources on all issues of the law related to the organization's human capital. Monitor legal issues and implications regarding discrimination, sexual harassment, health and safety, hiring and firing, as well as all other aspects of employee rights and responsibilities. • Advise and represent the organization on legal issues concerning patent, copyright, and trademark, real estate, or privacy matters. • May examine legal data to determine advisability of defending or prosecuting a lawsuit. Study statutes, decisions and ordinances to determine appropriate plan of action. Prepare files and take cases to trial if out-of-court settlements cannot be reached or coordinate such legal matters handled by outside counsel. Assess impact of case outcomes and initiate steps to implement any resultant changes. • May supervise outside counsel's performance of outsourced legal work for quality, cost, and effectiveness. • Execute strategic initiatives with guidance from senior management, including supervising projects and implementing policies. • May review due diligence and assist in the preparation of documents for corporate transactions. • Assist operations in assessing various risks associated within their respective business line. • May examine quality assurance or other regulatory issues to determine action plans for compliance with state and national legal requirements. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES •Strong organizational, planning, project management, communication, presentation and influence skills. •Strong business acumen •Solid understanding of the pharmaceutical industry and/or drug development process •Solid understanding of the government regulations that effect the operation of the organization •Solid understanding of drug discovery and development •Demonstrated ability to work creatively in a fast-paced environment •Demonstrated sound decision-making skills •Excellent skills using MS Office Suite: MS Excel, MS Word, MS PowerPoint •Exceptional attention to detail and ability to work simultaneously on multiple priorities •Ability to work independently •Ability to articulate legal issues and effectively make recommendations at the Sr. Management level •Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE •Bachelor's degree and JD with 12 years related experience, including 9 years experience in corporate law; or equivalentcombination of education, training and experience2012-04-21 05:45:08United StatesQuintilesNorth Carolina1205903NCResearch Triangle Park, NC28055410http://quintiles.jobs/xml/28055410/jobUSAResearch Triangle ParkTitle: Associate Director, Clinical Quality Assurance (GCP) - US based Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Associate Director, Clinical Quality Assurance to join our team! Purpose: Oversee and coordinate the GCP quality assurance program for assigned customer projects at a regional and/or global level. Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites within the region. Act as line manager for one or more QA staff. Responsibilities: * Provide guidance, interpretation, support, training, and key input to clinical development operational staff on interpretation of GCP regulations, guidelines, corporate standards, and policies. * Host customer audits and participate in review of corrective action plans. * Recommend systems for audit, write systems and procedures audit plans and coordinate scheduling, conduct, reporting and closure of internal systems and procedures audits. * Plan, schedule, conduct, report and close audits of clinical research activities in any of the countries involved with corporate contracts. * Serve as Global QA Contact for assigned customers and Quintiles functional areas. * Oversee documentation, reporting, and closure of compliance issues. * Support director in proposal reviews and reporting QA metrics. * Conduct trend analysis of audit results and provide QA management with initial root cause analysis * Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections. * Recommend staff management actions in accordance with organization's policies and applicable laws. Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. * Bachelor's/primary degree in life sciences or medically related field; or equivalent paramedical qualifications; with 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. * A minimum of 3 years of management experience; or equivalent combination of education, training and experience. * Knowledge of word-processing, spreadsheet, and database applications. * Strong knowledge of pharmaceutical research and development processes and regulatory environments. * Considerable knowledge of quality assurance processes and procedures. * Strong interpersonal skills. * Excellent problem solving, risk analysis, and negotiation skills. * Effective organization, communication, and team orientation and leadership skills. * Ability to influence and guide others. * Bachelor's/primary degree in life sciences or medically related field; or equivalent paramedical qualifications; with 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. * A minimum of 3 years of management experience; or equivalent combination of education, training and experience. * Knowledge of word-processing, spreadsheet, and database applications. * Strong knowledge of pharmaceutical research and development processes and regulatory environments. * Considerable knowledge of quality assurance processes and procedures. * Strong interpersonal skills. * Excellent problem solving, risk analysis, and negotiation skills. * Effective organization, communication, and team orientation and leadership skills. * Ability to influence and guide others.2012-04-21 05:44:58United StatesQuintilesNorth Carolina1205892NCResearch Triangle Park, NC28055409http://quintiles.jobs/xml/28055409/jobUSAResearch Triangle ParkTitle: Patient Recruit Specialist 2/Sr. Patient Recruitment Specialist/Patient Recruitment Manager Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking a Patient Recruit Specialist 2 to work with our ISS Division. Primary Job Function:Collaborate with Management for the coordination, planning, and implementation of Patient Recruitment and Retentionstrategies. May be responsible for smaller programs in their entirety. Communicate with sponsors and project teams to faciliate and execute the recruitment strategy. Collaborate with vendors as needed in the execution of any recruitment and retentiona initiatives. Provide support to Project Management and Business Development for new business opportunities. Participate in proposal development for Patient Recruitment and Retention strategies on new business opportunities including but not limited to; gathering background information on indication and previous work, attending strategy meetings, writing Recruitment and Retention strategy text, developing Recruitment and Retention budget, and attending bid defense meetings as required Job Responsibilities: * Serve as internal consultant to project teams for existing projects needing Recruitment and Retention services. * Manage the scope of work, objectives, quality of deliverables, and other activities of small projects as deemed necessary(projects are designated as small in regard to scope and/or profile of project). * May serve as primary project contact for Patient Recruitment and Retention programs with Sponsor to ensure appropriateCommunication channels are maintained and reporting schedules adhered to as required. * Assist in the management of project budget(s) to meet financial and company goals (realization targets). * Coordinate project activities for team members regarding their project-oriented tasks to ensure that project milestones are met. * Develop and implement risk management plans for minimizing impact on project objectives and deliverables. * Provide technical expertise as necessary in support of project specific and interdepartmental training efforts. * Assist with development of site performance metrics. * Maintain knowledge of current recruitment trends, vendors, and technologies to increase productivity and recommend * Process improvements to ensure quality in the unit. * Other duties as assigned by Management. Basic knowledge and understanding of applicable regulations. Good working knowledge of clinical research. Basic knowledge and understanding of Quintiles clinical systems and procedures. Proficient in the use of Microsoft Office. Good communication skills, both verbal and written. Highly motivated and organized. Demonstrated ability to coordinate and oversee teams. Ability to utilize initiative and to work independently, as required. Ability to establish and maintain effective working relationships with coworkers, managers and clients Prior experience in patient recruitment in a clinical setting a plus2012-04-20 04:50:33United StatesQuintilesNorth Carolina1206118NCResearch Triangle Park, NC28027329http://quintiles.jobs/xml/28027329/jobUSARaleighTitle: Statistical Programmer 1 Location: USA-North Carolina-Raleigh Other Locations: CAN-Quebec-Montreal Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. Quintiles is seeking an enthusiastic Statistical Programmer 1 to join our GFR Biostatistics team. Position can be office based out of Raleigh, NC or Montreal, Canada. The Statistical Programmer 1 will provide programming expertise as part of the Statistical Programming (SP) team to develop and maintain programs to meet internal and external clients' needs. Provide and assist in leading the development of project-related solutions to a wide range of statistical programming tasks. RESPONSIBILITIES • Perform and plan: (i) the programming, planning, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks. • Program the integration of databases from multiple studies or sources, under supervision. • Develop programming documentation including plans and specifications, as appropriate, under supervision. • Provide advanced technical expertise in conjunction with internal and external clients, and bring project solutions to SP teams and the Statistical Programming department, under supervision. • Develop, implement and validate new process technologies, macros and applications under supervision. • Fulfill project responsibilities at the level of assisting the lead. • Manage project budget and resource requirements.• Masters degree or educational equivalent in computer science or related field; Bachelor's degree or educational equivalent in biostatistics or related field and 1 year relevant experience; or equivalent combination of education, training and experience • Knowledge of statistics and/or clinical drug development process • Working knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Aptitude for mathematical calculations • Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities.2012-04-20 04:50:06United StatesQuintilesNorth Carolina1205897NCRaleigh, NC28027328http://quintiles.jobs/xml/28027328/jobUSAResearch Triangle ParkTitle: Internship: Corporate Digital Strategy Coordinator Location: USA-North Carolina-Research Triangle Park Other Locations: Description A career at Quintiles Transnational Corp. puts you at the corporate center of the leading worldwide pharmaceutical services organization. Apply now for our Corporate Digital Strategy Coordinator/Intern located in our Research Triangle Park, NC office. We are currently seeking an Intern to facilitate digital patient recruitment. Key responsibilities include: · Track registration campaigns and analyze metrics for success · Send out and track newsletters · Track and analyze site performance; optimization · Research vendors for potential registration partnerships · Research and maintain list of condition-based digital communities · Weekly Linkedin metrics tracking and reporting · Social media metrics analysis and reporting by campaign · Development of monitoring schedule process and documentation using Radian6 · Content Calendar Research and Development · Social CMS management and optimization The ideal candidate will be a web-savvy media/journalism/marketing student with a thorough understanding of web content strategies and best practices. This internship offers the opportunity to work with a dynamic group of digital strategist as we prepare for the launch of Quintiles.com, ClinicalResearch.com and several patient-oriented sites. Note: This is not a programming position. Development activities are outsourced. Qualifications · Pursuing a Bachelor's degree (Marketing or Communication concentration preferred) · Writing and editing with attention to detail and ability to manage multiple projects · Experience with emerging Web technologies and with content updating via an html editor · Proficiency in MS Office suite · Excellent interpersonal, verbal/written communication and organizational skills · Must work well independent of supervision · Experience using a content management system a plus, but not mandatory2012-04-19 04:41:03United StatesQuintilesNorth Carolina1205837NCResearch Triangle Park, NC27998695http://quintiles.jobs/xml/27998695/jobUSAMariettaTitle: Sr Medical Technologist - Molecular Biology Location: USA-Georgia-Marietta Other Locations: Manage instrumentation and technologists to ensure that laboratory results are reported accurately and in a timely manner. Maintain supply inventory and communicate operational issues to management. Perform routine testing and troubleshoot problems. Assist Laboratory management with the development of new methods, safety, and training. RESPONSIBILITIES * Oversee the daily responsibilities of an assigned technical area. * Initiate training of new staff within the technical group. Train staff Medical/Histo Technologists and Medical/Histo Laboratory Technicians and/or Assistants in proper laboratory techniques for existing and new methods. Evaluate daily performance of staff for adherence to standard operating procedures (SOPs) and efficient workflow. * Act as primary resource for Medical/Histo Technologists and Medical/Histo Laboratory Technicians and/or Assistants in the technical area to resolve testing issues and analyzer maintenance. * Maintain quality control of laboratory testing to ensure accurate and timely lab reporting. Document corrective and preventative actions taken using good documentation practices. * Perform moderate/highly complex analysis of patient specimens. Evaluate validity of specimen results as per SOP guidelines. Document all corrective actions taken. * Assist management in establishing new methodologies. Assist in completion of validation packages. Participate in selection process for new instrumentation. * Assist management with writing or implementing SOPs for laboratory testing and safety procedures. Implement changes in laboratory notifying all employees of necessary changes. Notify management when updates to department SOP manuals are needed to reflect procedural changes. * Follow safety procedures as per laboratory SOPs. * Collaborate with Project Manager with client requests and concerns. Notify management of any delays in testing and any related factors. * Identify appropriate vendors and orders laboratory supplies as directed by management in order to maintain consistent workflow. * Participate in continuing education through self-study, attending off-site lectures and preparing programs to share with coworkers. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree or educational equivalent in Medical/Histo technology , or Medical related science, and 4 years relevant experience or equivalent combination of education, training and experience * Applicable certifications and licenses as required by country, state, and/or other regulatory bodies REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge of clinical procedures used in the area of molecular biology, genetics, molecular pathology or virology * In depth knowledge of good laboratory practices (GLP) and other regulatory agency standards within area of responsibility * In depth knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling * Indepth knowledge of laboratory equipment, instrumentation and terminology used in the area of molecular biology such as PCR, real time PCR, quantitative PCR, DNA extraction, Luminex, sequencing, laboratory automation * Effective computer skills. * Ability to maintain effective reporting procedures and control workflow * Ability to establish and maintain effective working relationships with coworkers, managers and clients PHYSICAL REQUIREMENTS * Work is performed in a laboratory environment, full manual dexterity and visual acuity required * May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment2012-04-19 04:41:00United StatesQuintilesGeorgia1205821GAMarietta, GA27998694http://quintiles.jobs/xml/27998694/jobUSAIthacaTitle: Shipping & Receiving Associate Location: USA-New York-Ithaca Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our 23,000 engaged professionals in over 60 countries are committed to making people healthier. The work we do in every therapeutic discipline makes a difference in the lives of patients everywhere. For example, Quintiles has helped develop or commercialize 100% of all Diabetes products approved between 2004 and 2010. In fact, Quintiles has helped develop or commercialize all of 2010s top 50 best selling products or compounds. Join us as we define TheNewHealth. We are currently seeking for a Shipping & Receiving Associate to join our staff in Ithaca, New York. Purpose The Shipping & Receiving Associate will coordinate all aspects of packaging, shipping, and receiving goods. Responsibilities * Work with organization teams and external vendors to assure all shipping needs are met. * Provide first class customer service to all Advion teams. * Improve systems through innovative and creative methodology. * Ensure DOT compliance with all in/outbound shipments. * Coordinate all aspects of receiving : * Distribute supplies, spare parts, and business correspondences, * Stock supplies in proper storage location, * Document receipt of supplies and spare parts on packing slips, * Provide slips to Procurement. * Coordinate all aspects of shipping: * Arrange daily and special out bound shipments, * Package all products, * Create required shipping labels, * Ensure that all prepackaged/labeled packages produced by the Administrative Team are shipped in accordance with required method of transport. * Assist with the management of inventory system and procurement department as needed. * Maintain an organized and clean dock as space allows. Required Knowledge, Skills and Abilities * Ability to maintain accurate records * Ability to provide effective client communication. * Ability to establish and maintain effective working relationships with coworkers, managers and clients. * Good computer knowledge and data entry skills Minimum required Education and Experience * High School Diploma with 2 years' related experience; or equivalent combination of education, training and experience in a GLP analytical laboratory.2012-04-19 04:40:38United StatesQuintilesNew York1205871NYIthaca, NY27998692http://quintiles.jobs/xml/27998692/jobUSANew York CityTitle: Sales Consultant - New York Metro 6650 Location: USA-New York-New York City Other Locations: USA-New Jersey, USA-New York-Long Island Sales Consultant As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams helpHealthcare companiesget their products to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking fora NIOX SalesConsultant to join our client's sales team. In this role you will be working directly for Aerocrine, a medical technology company focused on improving the treatment of patients with asthma. Measuring airway inflammation helps doctors to diagnose, monitor and optimize therapy for people with asthma. Sales Consultant The Sales Consultant will target, promote and sell our partner's therapeutic products to Allergists, Pulmonologists and hospital PFT Labs as directed. The Sales Consultant manages an assigned territory in order to grow our customer's business among a targeted physician audience and further develop relationships with new physician groups to achieve customer objectives.They will also train and in-service the staff when they sell a NIOX MINO system.The Sales Consultant will also be responsible for providing quality consultative services, coordinating and integrating outside alliances and providing resources to fit customer needs. Our customer offers a friendly, progressive work atmosphere and a comprehensive benefits package. Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required · 2 plus years of device or full-office pharmaceutical sales or medical sales experience required · A documented track record of success · Ability to demonstrate proven sales performance over time · Proven ability to manage a large territory and use analytics to create strategy for identifying the most productive targets. · Must be able to demonstrate proven ability to change customer's behavior and close the sale, transactional based. · Must reside within the territory in an appropriate location to efficiently work the territory · Strong work ethic and customer focus orientation · Excellent communication and organization skills · Must be able to travel extensively as required to manage territory Preferred Skill Set: · Have interest, desire and ability for upward career growth · Have 2-4 years of successful Medical Device experience Competencies · Demonstrated analytical skills · Demonstrated Business Acumen · Demonstrated success in persuasion, influence and negotiation skills · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Knowledge of and experience with the selling process · Initiative & execution-oriented2012-04-19 04:40:25United StatesQuintilesNew York1206033NYNew York City, NY27998690http://quintiles.jobs/xml/27998690/jobUSANoneTitle: Sales Consultant - South Florida 6650 Location: USA-Florida Other Locations: Sales Consultant As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams helpHealthcare companiesget their products to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking fora NIOX SalesConsultant to join our client's sales team. In this role you will be working directly for Aerocrine, a medical technology company focused on improving the treatment of patients with asthma. Measuring airway inflammation helps doctors to diagnose, monitor and optimize therapy for people with asthma. Sales Consultant The Sales Consultant will target, promote and sell our partner's therapeutic products to Allergists, Pulmonologists and hospital PFT Labs as directed. The Sales Consultant manages an assigned territory in order to grow our customer's business among a targeted physician audience and further develop relationships with new physician groups to achieve customer objectives.They will also train and in-service the staff when they sell a NIOX MINO system.The Sales Consultant will also be responsible for providing quality consultative services, coordinating and integrating outside alliances and providing resources to fit customer needs. Our customer offers a friendly, progressive work atmosphere and a comprehensive benefits package. Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required · 2 plus years of device or full-office pharmaceutical sales or medical sales experience required · A documented track record of success · Ability to demonstrate proven sales performance over time · Proven ability to manage a large territory and use analytics to create strategy for identifying the most productive targets. · Must be able to demonstrate proven ability to change customer's behavior and close the sale, transactional based. · Must reside within the territory in an appropriate location to efficiently work the territory · Strong work ethic and customer focus orientation · Excellent communication and organization skills · Must be able to travel extensively as required to manage territory Preferred Skill Set: · Have interest, desire and ability for upward career growth · Have 2-4 years of successful Medical Device experience Competencies · Demonstrated analytical skills · Demonstrated Business Acumen · Demonstrated success in persuasion, influence and negotiation skills · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Knowledge of and experience with the selling process · Initiative & execution-oriented2012-04-19 04:40:22United StatesQuintilesFlorida1206034FLFlorida, USA27998688http://quintiles.jobs/xml/27998688/jobUSAOverland ParkTitle: Clinical Research Associate / CRA / Senior CRA - Nationwide Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience. - Prefer BS/BA or RN - At least 1 yr site monitoring experience - Customer service orientation - Sound knowledge of medical terminology and clinical monitoring process - In depth therapeutic and protocol knowledge as provided in company training - Ability to perform travel an average of 65%, depending on project needs - Excellent verbal and written communications skills - Excellent interpersonal and organizational skills and attention to detail - Computer literacy, proficiency in MS Office2012-04-18 05:42:44United StatesQuintilesKansas1205716KSOverland Park, KS27973467http://quintiles.jobs/xml/27973467/jobUSAMemphisTitle: Clinical Research Associate / CRA / Sr. CRA - Memphis - PHASE I ONCOLOGY ~ Location: USA-Tennessee-Memphis Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Memphis, TN! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Prefer BS/BA. - 2yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology and Phase I experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-18 05:42:42United StatesQuintilesTennessee1205910TNMemphis, TN27973466http://quintiles.jobs/xml/27973466/jobUSANoneTitle: Business Development Manager/Associate Director (Pacific North West) Location: USA-California Other Locations: New Business developer needed on the pacific west coast. Candidate must reside in or be willing to relocate to WA, OR, or Western Canada. Hunters only, as role is 75% new business development and 25% account management. Must attend 12 new meetings/sales calls per month. PURPOSE Secure and retain business through professional, consultative, proactive sales activities directed at decision-makers and decision influencers at existing and new clinical sponsors. RESPONSIBILITIES · Actively prospect and leverage potential new business opportunities within specified customer account(s). · Cultivate strong, long-term relationships with key decision-makers within Account and develop in-depth knowledge of the customer organization. · Maintain general knowledge of all Quintiles services for appropriate cross-sell opportunities. · Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards. · Analyze potential opportunities and develop sales plans for each target account. Ensure appropriate strategy/solution is proposed to customer. Monitor actions and results against plans. · Coordinate with contracts and proposals to develop proposal. · Work with operations and functional managers to identify sales team and prepares and leads the sales presentation. Educate team participants in customer culture, operational needs/methods and sales techniques needed to close the sale. · Handle follow-up related to the sale and drive completion of contractual documents. · Adapt successful strategies and tactics to meet market demands and financial targets. · Maintain high visibility within customer organization. Monitor customer satisfaction by communicating regularly with customer · Plan and coordinate all customer sales activities. · Record all customer sales related activities in CRM system. · Prepare sales activity report for Sales Management as required. · Serve as a liaison between the customer and technical and operational groups at Quintiles, Inc. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Proven track record at mid-level and high-level contacts. · Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business · Solid understanding of commercialization and the principles of drug discovery and development · Excellent analytical skills in assessing and interpreting customer business data · Ability to maintain demanding timelines · Ability to influence others internally and externally · Adaptability and flexibility to changing priorities · Demonstrated ability to work creatively in a fast-paced environment · Attention to detail and ability to work simultaneously on multiple priorities · Ability to work independently and as a team player · Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel · Excellent oral and written communication skills · Ability to establish and maintain effective working relationships with coworkers, managers and customers MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree in Business Management and 3-5 years related experience, including 1-2 years of relevant industry (CRO/Pharmaceutical) and/or sales experience; or equivalent combination of education, training and experiencePHYSICAL REQUIREMENTS · Use of keyboard requiring repetitive motion of fingers · Extensive use of telephone and face-to-face communication requiring accurate perception of speech · Frequent travel · Frequent long, varied hours2012-04-18 05:42:40United StatesQuintilesCalifornia1205906CACalifornia, USA27973464http://quintiles.jobs/xml/27973464/jobUSAIndianapolisTitle: IT Operational Lead and Transition Manager Location: USA-Indiana-Indianapolis Other Locations: IT Operational Lead and Transition Manager Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Overall Semio Lead position located in Indianapolis, IN. This is an executive level role; We are seeking candidates with exceptional leadership experience who can drive strategic development, change management and alliance management efforts. PURPOSE The Semio Operational Lead will lead all Semio day to day operations, including financial oversight, information support (procurement, processing and provisioning), and IT support (Help Desk). Drive the transition of this startup organization into a production service platform, through staff transitions, operating model changes, Technical Support models, etc Track and report development and delivery progress. Staff and manage the Semio development team. Line Management responsibilities for a matrixed team of senior IT and business staff from Quintiles and investment partner companies. The Operational Lead will report directly to the Overall Semio lead and be a peer of the Semio development lead. RESPONSIBILITIES · Drive the completion of the current 15 Month roadmap through robust IT Program Management · Manage staff in accordance with organization's policies and applicable legislation. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration. · Direct a broad group of IT and business staff responsible for all aspects of Semio IT development and service delivery. Encourage manager, within areas of accountability, to develop staff in accordance with career paths and in alignment with strategic Semio, Planning and Design, and corporate priorities. · Focus on transitioning Semio from a co-development to a solely Quintiles managed entity (staff, facilities, contracts, etc.) · Program management to assist the development lead to complete the approved roadmap to completion. · Direct and lead planning and oversight of Semio operations to achieve client expectations through the development, implementation, and delivery of Semio capabilities and services. Represent Quintiles interest on the operational committee to determine prioritization of development activities and variance to core plans · Establish project budgets, resource plans, milestones, tracking metrics, and success measures. Monitor project status reports. · Review and approve metrics to track quantity and quality of capabilities developed and services delivered. Identify opportunities to improve service and reduce costs. · Overall responsibility for ensuring Semio IT activities conform to Global IT Security standards and all data and systems are properly protected. Ensure proactive monitoring exists to detect intrusions, violations, or other unauthorized attempts to access or manipulate data or systems. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Strong Program management skills · Outstanding demonstrated leadership ability, particularly the ability to lead through change · Proven ability to influence and negotiate at the executive level, both internally and externally · Strong staff management skills and the ability to effectively manage multiple teams · Good understanding of legal agreements (master service agreements, work orders, leases, consulting service agreements, other) · Excellent financial management skills · Excellent verbal and written communication skills · Ability to manage, develop, administer, and track capital and operating budgets · Ability to establish and maintain effective working relationships with coworkers, managers and clients · Excellent interpersonal and collaborative skills for relationship building · Excellent insight and proactive problem solving through innovative and pragmatic solutions · Capacity and disposition for collaboration across disciplines · Good alliance management skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's Degree in Computer Science or related field; MBA preferred · 10 years IT experience including previous management experience · Ideally experience in joint venture or co-investment partnerships · Experience with executive board management, and interaction2012-04-18 05:42:40United StatesQuintilesIndiana1205907INIndianapolis, IN27973465http://quintiles.jobs/xml/27973465/jobUSAResearch Triangle ParkTitle: (ITLS) Project Director, Infosario Safety Location: USA-North Carolina-Research Triangle Park Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Project Director, Infosario Safety position located in our Morrisville (Raleigh/Durham), NC office. The Project Director, Infosario Safety position will plan, supervise, and manage the direction of customer programs related to the implementation of the Infosario Safety IT platform. These programs will be performed in collaboration with project team members and stakeholders, ensuring the integration, coordination, timing, and consistency of process throughout. The incumbent is expected to be able to deliver, within the constraints of scope, quality, time and cost, complete IT project solutions. The position will be expected to manage (functionally or through a matrix) the activities of multiple Project Managers and other Program team members. Excellent Engagement/Client management skills will also be required. RESPONSIBILITIES • Responsible for program, schedule, finance, and overall team management on large client-based IT implementations • Work with clients and business stakeholders to assure alignment between business objectives and engagement goals • Ensure that projects and workstreams successfully control and monitor progress, addressing risk and issue management, resource conflicts, effective communications, and stakeholder involvement, as appropriate • Ultimate accountability to Quintiles Management for the progress and management of large implementation programs • Work with financial stakeholders to support budget construction, as required, and to control expenditure to achieve financial objectives • Allocate local and global resources in accordance with strategic and tactical priorities and company goals and objectives. Request project team membership from other departments, if required. Actively compare competing needs and benefits against existing work and strategies. • Develop, implement, and review methods to assess quality and efficiency of work performed by team, including metrics, internal process improvement, Operating Procedures, and Work Instructions • Work with Quintiles Management in removing potential barriers that limit the effective delivery of IT projects/programs within the organization • Oversee work performed by vendors that could include software development, acceptance testing, or implementation • Maintain a working knowledge of the Drug Safety and IT industries • Manage and mentor staff in accordance with organizational policies and applicable laws. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; approving actions for Human Resource matters Qualifications • 10-15 years of IT experience, with a concentration in Project/Program Management • Minimum 5 years in a Senior IT Leadership position (Program Manager/Director, Client Partner, Functional Manager/Director) • Minimum 2 years of demonstrable Client and Relationship Management (internal and/or external) • Experience managing, coaching, and/or mentoring junior staff (particularly Project Managers) • Strongly prefer pharmaceutical, clinical research or biotechnology industry experience • Pharmacovigilance (Drug Safety) domain knowledge a strong plus • Experience managing teams in a matrix organization • Knowledge of the Software development life cycle and Computer Systems Validation in a regulated environment is a plus • BS degree required, MS degree a plus • PMP certification a plus2012-04-18 05:42:40United StatesQuintilesNorth Carolina1205909NCResearch Triangle Park, NC27973463http://quintiles.jobs/xml/27973463/jobUSAResearch Triangle ParkTitle: QCC Site Support Project Manager - IPT Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Manage the execution of QCC site management clinical studies, from initiation through to closeout. Ensure that all late phase clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. * Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. * Serve as primary project contact with internal PM to ensure communication is maintained and reporting schedules are adhered to. * Collect information on team performance against contract, customer expectations, and project baselines. * Lead problem solving and resolution efforts to include management of risk, contingencies and issues. * Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. * Provide input for the development of proposals for new work and manage project budgets. * Provide input to line managers of their project team members' performance relative to project tasks. * Prepare and present project information at internal and external meetings. * Participate in proposal development and in the bid-defense process with guidance and supervision. * Ensure high performance and efficiency of the QCC site management team REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines * Desired knowledge of Late Phase clinical studies and processes * Good therapeutic and protocol knowledge * Strong communication and interpersonal skills, including good command of English language * Excellent matrix management leadership skills * Good problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good teamwork skills * Excellent customer service skills * Good presentation skills * Good judgment * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients * MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 3 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. Experience in Observational Research studies is a strong plus. PHYSICAL REQUIREMENTS * Extensive use of keyboard requiring repetitive motion of fingers. * Extensive use of telephone and face-to-face communication requiring accurate perception of speech. * Regular sitting for extended periods of time. * May require occasional travel.2012-04-18 05:42:39United StatesQuintilesNorth Carolina1205902NCResearch Triangle Park, NC27973462http://quintiles.jobs/xml/27973462/jobUSAResearch Triangle ParkTitle: Business Intelligence Manager/ Associate Business Intelligence Director Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. A career at Quintiles puts you at the corporate center of the leading worldwide pharmaceutical services organization. If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. This role is to work with senior management to support strategic planning activities by providing actionable recommendations based on assessments of existing and potential markets. Elements and core capabilities of the role include: * Ability to develop analyses and models supporting financial, statistical and qualitative data analysis of markets and competitors * Willingness and interest to pursue primary and secondary research to create business case analyses of market adjacencies and new service solutions * Working towards the development of industry-leading knowledge management capabilities - enabling the team to effectively share and collaborate across the information and deliverables developed. Key responsibilities will include: * Working with internal business customers to enhance their use of strategic analysis and business intelligence, and ensuring that the appropriate communication channels are maintained. * Developing relationships with key internal/external customers to identify emerging needs and business challenges. * Creating and presenting value-added insights and solutions to meet business needs * Contributing to strategy development activities. * Maintaining an in-depth knowledge of designated markets and trends through market research, data manipulation and financial modeling and analysis. * Supporting the implementation of strategic analysis projects and business plans - designing and managing the scope of work, objectives, quality of deliverables and activities on projects and delivering assigned activities. * Ensuring the group meets established goals and objectives. * Maintaining knowledge of current trends and developments in the business intelligence field by reading appropriate journals, books, and other literature. * Managing and improving the return on our vendor relationships (e.g. data, secondary research, news feeds, etc.). Apply now for our Manager / Associate Director- Business Intelligence position within the Corporate Strategic Services department, located in our Research Triangle Park, NC headquarters. The Corporate Strategic Services group works closely with the enterprise and business unit leadership of Quintiles to chart the strategic agendas for growth. The team evaluates market and business trends and opportunities and identifies strategies that can help Quintiles achieve its aspirations. The Business Intelligence function provides actionable insights on the market, customers and competitors that form the foundation of this decision making. The team is responsible for strategic data and information, trend and scenario analysis, and other business analytics in support of strategic planning and execution. * Bachelor's Degree in a life science, finance or marketing subject. An MBA is preferred. * A minimum of 3-7 years relevant business experience in management consulting, business intelligence, corporate strategy, marketing or finance, or other comparable combination of education, training and experience. * Good understanding of the pharmaceutical and biotech industries. CRO/Pharmaceutial industry knowledge and experience is preferred. * An affinity for and demonstrated ability in strategic or competitive intelligence and analytics - including data analysis and visualization with an inquisitiveness and ability to comprehend new business concepts and structured thinking * Strong financial and analytical skills. Familiarity with utilizing statistics in a business setting is a plus. * Ability to network effectively at all levels and influence without direct management oversight. * Demonstrated ability to characterize industry best-practices, focus across longer-term projects and ability to communicate value of a concept. * Strong customer focus and organizational skills with the ability to manage multiple projects under deadline constraints. * Ability to articulate with strong presentation skills, excellent written communication abilities and contribute to executive-level discourse. * Orientation towards constantly seeking new knowledge; a quick study on new topics. * Positive approach to quality of work. * Able to operate within an open team environment. * High level of competence with Microsoft Office suite (especially Excel) is essential.2012-04-18 05:42:32United StatesQuintilesNorth Carolina1205642NCResearch Triangle Park, NC27973461http://quintiles.jobs/xml/27973461/jobUSAResearch Triangle ParkTitle: Clinical QA Auditor /Senior Clinical Quality Assurance Auditor - RTP, NC Location: USA-North Carolina-Research Triangle Park Other Locations: USA-California-San Diego, USA-New Jersey-Parsippany The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Senior Quality Assurance Auditor to join our team! Sr QA Auditor will plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures; prepare and distribute reports of findings to supervisor, operations staff, management, and customers; provide consultation in interpretation of regulations, guidelines, policies, and procedures; support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Responsibilities: * Planning, scheduling, conducting, and reporting audit in any of the countries involved with Quintiles contracts. * Evaluating audit findings and preparing and distributing reports to operations staff, management, and customers. * Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. * Preparing, reviewing and approving corrective action plans, following implementation of corrective actions and closing audits. * Presenting educational programs and providing guidance to operational staff on compliance procedures. * Evaluating policies and procedures for compliance with applicable regulations/guidelines and providing recommendations to management for continuous process improvements. * Hosting customer audits. * Assisting in hosting regulatory facility inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed. * Assisting in training of new Quality Assurance staff. Locations: RTP, NC, Parsippany, NJ and San Diego, CA Bachelor's degree and 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GXP and GCP experience; or equivalent combination of education, training and experience. * Knowledge of word-processing, spreadsheet, and database applications. * Extensive knowledge of pharmaceutical research and development processes and regulatory environments. * Knowledge of quality assurance processes and procedures. * Strong interpersonal skills. * Excellent problem solving, risk analysis and negotiation skills. * Strong training capabilities. * Effective organization, communication, and team orientation skills. * Ability to initiate assigned tasks and to work independently. * Ability to manage multiple projects. * Ability to establish and maintain effective working relationships with coworkers, managers and clients. Travel around 60%2012-04-18 05:42:30United StatesQuintilesNorth Carolina1205637NCResearch Triangle Park, NC27973460http://quintiles.jobs/xml/27973460/jobUSAMonroeTitle: Pharmaceutical Sales Rep - Eye/Ear Monroe, LA 6175 Location: USA-Louisiana-Monroe Other Locations: We are excited to announce that at this time we are looking for Sales Representatives to join our team of over 7,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting the largest specialty eye care company in the world and have the opportunity to become part of their team at the end of contract. Sales Representative - Eye and Ear The Sales Representative targets, promotes and calls primarily on Pediatricians and Otolaryngologists as well as some Primary Care Physicians, General Practitioners and Family Practitioners. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. Conduct face-to-face presentations with physicians to educate them on both current and future products. The Specialty Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, as well as other internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including competitive compensation and bonus structure, car allowance, medical, dental, life insurance and vision coverage, tuition assistance and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com Be sure to reference job code 6175. EOE • 4 year degree required • 1 year of Business to Business sales experience a plus or recent college graduate with demonstrated leadership in community, professional and/or college organizations • Strong work ethic and customer focus orientation • Excellent communication and organization skills Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-04-18 05:42:22United StatesQuintilesLouisiana1205878LAMonroe, LA27973458http://quintiles.jobs/xml/27973458/jobUSACambridgeTitle: Manager of Field Services — Quintiles Consulting, Market Intelligence Location: USA-Massachusetts-Cambridge Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. The Market Intelligence Practice within Quintiles Consulting is a team of individuals with a blend of industry, operational, clinical, and life science expertise focused on biopharmaceutical market research. The practice uniquely benefits from the unparalleled resources of a larger organization, and the agility and fresh-minded thinking of a smaller independent firm. The team provides industry leading business insights backed by data-driven analytics to inform "high-stakes" strategic decisions across all stages of drug development and commercialization. The practice is seeking motivated and inspired thinkers to share the goal of informing biopharmaceutical business decisions and driving success in a constantly evolving and competitive global market. Exceptional team members have come from an array of backgrounds and have had academic, industry, consulting, or operations experience. All share a passion for collaboration, innovation, and analytical thinking, making for a stimulating and fun workplace. Colleagues within the practice play a fundamental role in shaping a fast-growing evidence-based consultancy, and are presented with many opportunities to further develop their careers. The Market Intelligence Practice is currently seeking a Manager of Field Services to join the Cambridge, MA office. Responsibilities include: * Manage vendor relationships * Develop and maintain global vendor relationships, negotiate contracts and discounts * Monitor vendor quality guidelines, provide direct feedback * Work closely with the Director of Finance and Managing Director to monitor and control annual field costs * Direct all aspects of research field operations on global qualitative and quantitative market research projects: * Provide project management support to ensure data collection meets study objectives * Review recruitment and research materials and provide feedback * Coordinate project flow between internal departments; Select and manage vendors to execute and complete projects on time and within budget * Brief vendors on study objectives and specifications to ensure quality and timely delivery * Oversee data collection process and provide client-ready status reports * Manage quotas and monitor field progress, response rates, and incidence * Recognize and correct project inefficiencies, troubleshoot any fielding issues * Collaborate with team members to foster client relationships and produce high-quality deliverables * Support proposal development * Prepare requests for vendor quotations, confirm feasibility of sample, collect and evaluate bids * Create fielding budgets and assist proposal leads with timeline creation * Review proposals for research scope and timing and provide feedback * Leader of field team * Act as supervisor to 2 Field Managers * Develop skills of team members, manage workflow, and monitor performance * Help troubleshoot fielding issues and brainstorm creative solutions across Research Operations team * Stay current in field product offerings and provide training to staff In addition to the following requirements, we are seeking the profile of a candidate that has had strong academic success, holds themselves to the highest standard of professionalism, and is motivated to be successful in the consulting industry. * Record of academic excellence and work performance * BA/BS and relevant work experience * 5 years experience in market research field management * Prior experience working with sample providers, programmers, and qualitative facilities * Prior experience creating field budgets and negotiating vendor discounts * Peferred experience in healthcare market research * 2 years management experience * Effective planning and leadership skills * Ability to handle multiple projects in a fast-paced, deadline-driven environment. Effective and efficient multitasking * A client-service oriented focus and outlook * Pride and ownership in all work efforts with a strong attention to detail * Flexible skill set and work style that thrives in doing both independent tasks and contributing to a team environment * Excellent oral and written communication * Strong computer skills (MS Excel, MS Word, MS PowerPoint, MS Outlook, Internet)2012-04-17 06:03:10United StatesQuintilesMassachusetts1205811MACambridge, MA27941989http://quintiles.jobs/xml/27941989/jobUSANoneTitle: Sr. Clinical Project Manager / Associate CPM Director - Respiratory Location: United States Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE We are recruiting a Sr. Clinical Project Manager / Associate Clinical Project Management Director specializing in Respiratory studies within our Clinical Project Management Departmentto manage the execution of medium to large multi regionally-based clinical studies, from initiation through to closeout. This role is responsible for ensuring that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects. * Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. * Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to. * Report on team performance against contract, customer expectations, and project baselines to management. * Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk. * Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. * Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. * Provide input for the development of proposals for new work and project budgets. * Provide input to line managers of their project team members' performance relative to project tasks. Recommend team members' further professional development. Support staff development. Mentor less experienced CPMs. * Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team. * Prepare and present project information at internal and external meetings. * Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff. * Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in life sciences or related field and 7 years' clinical research experience including 4 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. * Project Management exprience within Respiratory, is required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines * In depth therapeutic and protocol knowledge * Strong communication and interpersonal skills, including good command of English language * Strong organizational and problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good team leadership skills * Effective mentoring and training skills * Excellent customer service skills * Good judgment * Effective presentation skills * Ability to manage competing priorities * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-04-16 11:11:37United StatesQuintilesNone1205803NoneVirtual, USA27917738http://quintiles.jobs/xml/27917738/jobUSABirminghamTitle: Specialty Representative — Birmingham, AL 6508 Location: USA-Alabama-Birmingham Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that our client,Pacira Pharmaceuticals, is preparing to build a national hospital sales force in anticipation for a new product launch. We are looking for Hospital Specialty Representatives focused in various regions across the country to join this highly specialized and elite team of professionals. Job Description & Qualifications: Specialty Representative - Hospital The primary objective of the specialty representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The specialty representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience ·4 year Bachelor's degree from an accredited University required ·3 plus years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required. ·Prior hospital sales experience is required. ·Proven track record of success in competitive selling environment ·Documented sales results, including examples of company awards, or participation in management development program are preferred. ·Strong verbal, interpersonal and listening skills ·Residence within the current geography is required. Competencies ·Demonstrated analytical skills ·Demonstrated Business Acumen ·Demonstrated success in persuasion, influence and negotiation skills ·Demonstrated ability to apply technical/scientific knowledge ·Flexibility to learn new products over time ·Knowledge of and experience with the selling process ·Initiative & execution-oriented ·Teamwork2012-04-16 11:10:54United StatesQuintilesAlabama1205805ALBirmingham, AL27916524http://quintiles.jobs/xml/27916524/jobUSAResearch Triangle ParkTitle: Sr. Director, IPT Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Integrated Processes and Technologies (IPT) provides cross-functional solutions integrating people, processes and technologies in order to make effective business decisions. Provide leadership in defining global initiatives, including scope, teams and stakeholders within IPT. Responsible for leading others to ensure alignment with strategy and that budget management and deliverables meet expectations. Will shape and direct customer interaction and participate and lead in governance activities. RESPONSIBILITIES * Manage staff in accordance with organization's policies and applicable regulations. * Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees and addressing employee relations issues. * Approve actions on human resources matters. * Provide guidance and direction of the scope of work, objectives, timelines, risks, quality of deliverables and other activities for employees in assigned group. * Define and lead the direction for change, establish strategic intent and action plans as aligned with the corporate strategy and vision and serves as role model for change and adoption across the organization. * Obtain and provide regular feedback to employees from other team members and key stakeholders to assist in personal and professional development. Identify skill and competency gaps at the individual level * Coach and mentor employees and management staff around planning and prioritization of work activities, risk management and problem solving to ensure global alignment of work practices. * Identification of skill/competency gaps and development of strategies to address. * May have responsibility to identify, resolve and assess trends on quality issues for implications across other functional areas and across the enterprise and customer interface. * May be responsible for developing and delivering strategies for components of stewardship. * Actively manage workload assignments and review appropriateness of workload metrics. Accountable for resourcing and hiring decisions. * Ientify and implement effective strategies to ensure efficiency gains improving ROI. * Actively strategize in order to utilize resources in a matrix/collaborative manner. * Ensure alignment with IPT strategy, ensuring the alignment with corporate and functional strategic objectives. * Lead function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison. * Prepare, justify and direct budget allocation within remit. Accountable for ensuring that budget and financial targets are met. Support organizational cost control mechanisms. * Assist with the identification of revenue generating activities within IPT. Implement as needed. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Advanced knowledge of SOPs, GCPs, related regulatory requirements and systems or process requirements as well as the inter-workings of the Clinical Development Business * Excellent computer literacy, organizational, communication and problem-solving skills * Proven ability to collaborate and work with others in a global environment to deliver results * Highly effective leadership skills with proven people management skills * Demonstrated innovative and strategic thinking ability and ability to lead and apply organizationally * Effective coaching and mentoring skills * Excellent customer service skills * Excellent negotiation skills * Demonstrated track record of effective judgment and decision making skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences, business or related field with 15 years experience in a clinical research environment. * Must have 10 years of leadership and project management experience, with specific knowledge of clinical systems or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS * Extensive use of telephone and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time * Travel required2012-04-16 08:58:12United StatesQuintilesNorth Carolina1205800NCResearch Triangle Park, NC27914749http://quintiles.jobs/xml/27914749/jobUSACincinnatiTitle: Clinical Research Associate / CRA / Sr CRA /Cincinnati Location: USA-Ohio-Cincinnati Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the Cincinnati, OH area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-16 08:57:28United StatesQuintilesOhio1205799OHCincinnati, OH27914715http://quintiles.jobs/xml/27914715/jobUSAParsippanyTitle: Medical Writing Team Leader, Medical Communications - Parsippany, NJ / Raleigh, NC Location: USA-New Jersey-Parsippany Other Locations: USA-North Carolina-Raleigh Medical Writing Team Lead - Medical Communications - US or UK based Quintiles currently has an exciting opportunity for a Medical Writing Team Lead to join their Medical Communications team. The ideal candidate for this role can either be based in either in Parsippany, NJ, Raleigh, NC or Berkshire, UK. Managing a team of 4-5 writers you will have extensive experience as a writer in medical communications as well as proven experience in line management and ideally, have publication planning expertise, and experience of writing for a wide range of audiences/media. Successful candidates will be strategic thinkers, who are comfortable contributing to business development and presenting at pitches as well as being creative and driven. Quintiles Medical Communications is an international medical communications agency that develops and produces a broad range of communications programs and materials on behalf of pharmaceutical industry. Working with our pharmaceutical clients, our activities include organizing international symposia, developing educational programs for physicians and patients, producing clinical trial investigator and participant support materials, and developing print/digital materials ranging from sales aids to peer-reviewed publications. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! To apply, please send your cover letter, resume and stated areas of therapeutic expertise to www.quintiles.com. Candidates who are contacted for an interview will be required to provide writing samples and take a writing test. EOE QUALIFICATIONS · Bachelor's degree in a life-science related discipline, plus 2-5 years' experience as a medical writer for pharmaceutical or healthcare-related industry required · Extensive writing experience within a medical communications agency - essential · Proven ability to manage a team, coaching/training/mentoring · Extensive experience in medical writing, reviewing and resource planning · Extensive experience with a wide range of medical communications materials, including publication planning, symposium and exhibition materials, pitch presentations and promotional materials (for a range of audiences) · Excellent project/time management and organizational skills, with a proven track record of managing large medical communications programs · Ability to monitor team outputs, ensuring all written materials are of high scientific quality and meet client strategic marketing objectives · Excellent interpersonal/communication skills, with demonstrated ability in coordinating and motivating staff to meet deadlines · Flexible attitude - managing ever-changing priorities · Familiarity with code of practice guidelines · Excellent presentation skills · Must live locally and be office-based; occasional travel required2012-04-16 07:50:13United StatesQuintilesNew Jersey1204501NJParsippany, NJ27910244http://quintiles.jobs/xml/27910244/jobUSASan MateoTitle: Primary Care Sales Representative - San Mateo, CA 7069 Location: USA-California Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-04-16 07:50:00United StatesQuintilesCalifornia1205751CASan Mateo, CA27910235http://quintiles.jobs/xml/27910235/jobUSAOverland ParkTitle: Research Nurse II, Night Shift Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. In Quintiles' Phase I Clinic, research studies are conducted each year that identify the medicines that will help people live happier and healthier lives. The medical professional who provides care and support for study volunteers are at the forefront of drug development. It's work worth doing. We currently have an exciting career opportunity for a Clinical Research Nurse II working the night shift, three 12-hour shifts per week. Variable schedule to include holidays. In this position, you will coordinate and participate in Phase I clinical research studies ensuring that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations. In addition, you will assist with the guidance and supervision of staff in this role. Additional responsibilities may include: * Coordinate and participate in clinical research studies conducted by a supervising investigator to ensure that data collected on study volunteers adhere to study protocol; may assist in screening volunteers for inclusion in study based on pre-determined criteria. * Administer investigational drugs to volunteers according to study protocol. * Confer with volunteers to explain purpose of study and obtain informed consent forms; explain procedures and practical issues such as timelines for visits and restrictions on food and drink. * Record volunteer clinical data in case report forms (CRFs). Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol. * Review CRFs; evaluate and interpret collected data and prepare protocol summary forms, statistical reports and analyses documenting progress, adverse trends and appropriate recommendations or conclusions. * Cooperate with study monitor and reserve sufficient time for questions during monitoring. * Participate in project meetings with clients and other members of the project team as needed. * Manage the unit after hours in the absence of senior staff, escalating problems to senior staff as required. * Bachelor's degree or educational equivalent in Nursing and 3 years relevant experience; or equivalent combination of education, training and experience * Must possess a current RN license in the State of Kansas * Good knowledge of Phase I clinical trials * In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules * Knowledge of Microsoft Office Products2012-04-13 08:57:27United StatesQuintilesKansas1204888KSOverland Park, KS27876018http://quintiles.jobs/xml/27876018/jobUSAPeekskillTitle: Primary Care Sales Representative - Peekskill, NY 7069 Location: USA-New York Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. We are launching a new partnership with a top tier pharmaceutical company. As a result of this new relationship, we are now actively seeking sales professionals to promote several state-of-the art pharmaceutical products, within specific geographical areas. This role will not only provide you the opportunity to earn impressive financial compensation, based on your performance, but your efforts will directly contribute to improving the lives of the patients your physicians treat. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Specifications for Primary Care Sales Representative: * Professionalism and ethics are a must; as a Pharmaceutical Representative you will be the manager of your own business and responsible for driving sales in a designated territory assignment and provide valuable continuing education and service to targeted physicians. * Entrepreneurial passion is needed for generating market share and market share growth for assigned professional pharmaceutical products within a specific geographic area. * As a Representative, you will be making selling presentations to physicians and other health care professionals, primarily in an office based setting within an assigned geography. * You will also be responsible for developing an understanding of the issues and opportunities unique to each geography, particularly in managed health care. * Representatives are entrusted with the management of allocated resources (samples, promotional and educational materials) to maximize return within regulatory and ethical guidelines. * The Representative maintains accountability for all pharmaceutical samples and stock packages in accordance with FDA and PDMA guidelines. * Proper utilization of the sales automation system to document call and program activity. * All Representatives participate in and are required to complete initial and ongoing product and development training. Qualifications/Experience: * 4 year Bachelor's degree from an accredited University required * 2 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry is required. * Prior experience in cardiovascular and/or metabolic therapeutic area is preferred. * Proven track record of success in competitive selling environment * Documented sales results, including examples of company awards, or participation in management development program are preferred. * Strong verbal, interpersonal and listening skills * Ability to travel overnight as required * Residence within the current geography is required. Competencies: KNOWLEDGE: * The ability to develop an understanding of pharmaceutical products, competition and industry/market (including applicable laws and regulations) * Stays current on payer models, disease states, new research and therapeutic developments * Requests opportunities to share knowledge with the team; willingly shares successes with others * Conducts business in a transparent and ethical manner ACCOUNT MANAGEMENT/SELLING: * Can articulate a value proposition to appropriately influence customers * Understands stakeholders in order to customize approach based on customer- specific needs and priorities * Develops long-lasting customer relationships to generate expanded product use in appropriate patients to improve patient care BUSINESS PLANNING: * Continuously improves the profitability of the business by developing, executing and adjusting business plans to drive results * Offers innovative ideas and solutions to resolve work problems; provides ideas with impact for the larger organization * Anticipates and responds to change; considers change an opportunity to learn TEAMWORK/COLLABORATION: * Cooperates well with others to achieve goals; is viewed as a team player * Influences others even without formal authority and works effectively in matrix environments * Demonstrates a willingness to listen to others and embraces diversity of people, culture and ideas. * Expresses dissatisfaction constructively and takes the initiative to make things better2012-04-13 08:57:12United StatesQuintilesNew York1205717NYPeekskill, NY27876015http://quintiles.jobs/xml/27876015/jobUSAIthacaTitle: Product Support Specialist, Instrumentation Software (Ithica) Location: USA-New York-Ithaca Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Product Support Specialist, Instrumentation Software position at our Advion division in our Ithaca, NY office. This may be filled as Product Support Specialist OR as a Senior Product Support Specialist depending on experience. * The Senior Software Support Analyst will specialize in instrumentation software, but is also highly capable of troubleshooting computer hardware and connectivity problems * Install and configure Instrument Controller workstations, perform routine hardware and software maintenance, and respond to trouble calls. * Receive escalated support tickets from help desk, and escalate to vendor support when necessary (escalations are expected to be minimal - the hopes are that this person capable enough to handle most trouble calls without escalating to vendor support). * Participates in the validation and qualification of laboratory software (helps develop IQ/OQ procedures and testing criteria, executes IQ and OQ scripts, creates and executes standard installation procedures). * Prefer Bachelor's Degree in Computer Science or related field * Requires at least 1 year of relvant experience (support, calibration and validation of laboratory systems) * Certifications in CompTIA A and Microsoft MCP highly desirable * Must be flexible in working off hours to maximize production instrument uptime * Must adhere to GLP requirement, as applicable * Must be able balance efficiency and effectiveness with great care, formal process and documentation discipline. * Some experience with operating Mass Specs is highly desirable * Estimate of 25% travel required, betwen Ithica, NY, Indianapolis, IN and Manassas, VA * Working knowledge of Microsoft server, workstation and networking technologies. * Working knowledge of industry standards with regards to system and network administration. * Possess excellent verbal and written communication skills. * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-04-13 08:57:08United StatesQuintilesNew York1205709NYIthaca, NY27876010http://quintiles.jobs/xml/27876010/jobUSAIndianapolisTitle: IT Onsite Support Specialist Location: USA-Indiana-Indianapolis Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our IT Onsite Support Specialist (Product Support Specialist, Instrumentation Software) position at our Advion division in our Ithaca, NY office. This may be filled as Product Support Specialist OR as a Senior Product Support Specialist, depending on experience. * The Senior Software Support Analyst will specialize in instrumentation software, but is also highly capable of troubleshooting computer hardware and connectivity problems * Install and configure Instrument Controller workstations, perform routine hardware and software maintenance, and respond to trouble calls. * Receive escalated support tickets from help desk, and escalate to vendor support when necessary (escalations are expected to be minimal - the hopes are that this person capable enough to handle most trouble calls without escalating to vendor support). * Participates in the validation and qualification of laboratory software (helps develop IQ/OQ procedures and testing criteria, executes IQ and OQ scripts, creates and executes standard installation procedures). * Prefer Bachelor's Degree in Computer Science or related field * Requires at least 1 year of relvant experience (support, calibration and validation of laboratory systems) * Certifications in CompTIA A and Microsoft MCP highly desirable * Must be flexible in working off hours to maximize production instrument uptime * Must adhere to GLP requirement, as applicable * Must be able balance efficiency and effectiveness with great care, formal process and documentation discipline. * Some experience with operating Mass Specs is highly desirable * Estimate of 25% travel required, betwen Ithica, NY, Indianapolis, IN and Manassas, VA * Working knowledge of Microsoft server, workstation and networking technologies. * Working knowledge of industry standards with regards to system and network administration. * Possess excellent verbal and written communication skills. * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-04-13 08:57:07United StatesQuintilesIndiana1205710INIndianapolis, IN27876009http://quintiles.jobs/xml/27876009/jobUSAIndianapolisTitle: WPF Developer (SEMIO) Location: USA-Indiana-Indianapolis Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. Quintiles has made theComputerworld's "100 Best Places to Work in IT"in 2008, 2009 and 2011 and Quintiles IT is the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500". In 2011 Quintiles was also listed in the top 25 for multinationals by the Great Place to Work Institute! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our WPF Developer position located in our Indianapolis office as part of our Semio partnership and aligned to IT internally. Senior WPF developer with 5 years using WPF. This individual will need to be a self starter that can not only estimate their own work but work with subject matter experts to define the work they will be estimating on. The development environment is Agile so a working knowledge of Agile would be helpful. Along with these requirements the candidate would need to have working knowledge of the following technologies: WPF Data Templates WPF Control Templates WPF Custom Controls WPF Styling (styles, triggers, resource dictionaries) C# 4.0 Web Services using ASP.NET SQL Databases (table design, stored procedures, views) REQUIRED EDUCATION & EXPERIENCE • Minimum BA/BS degree in Computer Science/Engineering. • Six or more years of progressive experience2012-04-13 08:56:47United StatesQuintilesIndiana1205725INIndianapolis, IN27876006http://quintiles.jobs/xml/27876006/jobUSABostonTitle: (Senior) Market Research Analyst Location: USA-Massachusetts-Boston Other Locations: About Quintiles The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. Practice Description The Market Intelligence Practice within Quintiles Consulting is a team of individuals with a blend of industry, operational, clinical, and life science expertise focused on biopharmaceutical market research. The practice uniquely benefits from the unparalleled resources of a larger organization, and the agility and fresh-minded thinking of a smaller independent firm. The team provides industry leading business insights backed by data-driven analytics to inform "high-stakes" strategic decisions across all stages of drug development and commercialization. The practice is seeking motivated and inspired thinkers to share the goal of informing biopharmaceutical business decisions and driving success in a constantly evolving and competitive global market. Exceptional team members have come from an array of backgrounds and have had academic, industry, consulting, or operations experience. All share a passion for collaboration, innovation, and analytical thinking, making for a stimulating and fun workplace. Colleagues within the practice play a fundamental role in shaping a fast-growing evidence-based consultancy, and are presented with many opportunities to further develop their careers. The Market Intelligence Practice is currently seeking two market research analysts to join the Cambridge, MA office. The role can be filled at either the Analyst or Senior Analyst level. Analyst Responsibilities * Our research analysts contribute to all phases of qualitative and quantitative research projects, including: * Designing and implementing research plans and methodologies * Conducting interviews and crafting surveys to target physicians, patients and/or managed care decision makers * Managing data collection with external vendors and internal quantitative experts * Analyzing data and synthesizing findings for key client deliverables * Working closely with project managers and other internal team members to foster client relationships and deliver high-value, market-leading insights to clients The ideal applicant is driven to help shape the healthcare landscape and biopharmaceutical industry, motivated to achieve success in consulting, and aspiring to grow and develop with the practice. Strong candidates possess an inquisitive nature and a proven ability to blend qualitative and quantitative research skills. Additionally: * Record of academic excellence and work performance * BA/BS and a minimum of 2 years in qualitative or quantitative market research, or other relevant work experience; or, * Advanced degree, preferably in the sciences, healthcare, applied research, or business * Pride and ownership in all work efforts and products * Excellent oral and written communication and confident presentation skills * Flexible skill set and work style that thrives in doing both independent tasks and contributes to a team environment * Upholds the highest standard of personal professionalism and work integrity * Available for 10-20% travel2012-04-13 08:56:35United StatesQuintilesMassachusetts1205693MABoston, MA27876001http://quintiles.jobs/xml/27876001/jobUSABostonTitle: Market Research Manager Location: USA-Massachusetts-Boston Other Locations: About Quintiles The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. Practice Description The Market Intelligence Practice within Quintiles Consulting is a team of individuals with a blend of industry, operational, clinical, and life science expertise focused on biopharmaceutical market research. The practice uniquely benefits from the unparalleled resources of a larger organization, and the agility and fresh-minded thinking of a smaller independent firm. The team provides industry leading business insights backed by data-driven analytics to inform "high-stakes" strategic decisions across all stages of drug development and commercialization. The practice is seeking motivated and inspired thinkers to share the goal of informing biopharmaceutical business decisions and driving success in a constantly evolving and competitive global market. Exceptional team members have come from an array of backgrounds and have had academic, industry, consulting, or operations experience. All share a passion for collaboration, innovation, and analytical thinking, making for a stimulating and fun workplace. Colleagues within the practice play a fundamental role in shaping a fast-growing evidence-based consultancy, and are presented with many opportunities to further develop their careers. The Market Intelligence Practice is currently seeking a market research manager to join the Cambridge, MA office. Manager Responsibilities Research managers guide and inform all phases of qualitative and quantitative research projects, and are key drivers in growing existing and new client relationships. Responsibilities include: * Implementing global and domestic qualitative and quantitative market research projects: * Serving as project lead and collaborative team member * Projects typically support business decisions surrounding new product development, such as market demand, pricing, and segmentation * Managing all aspects of research: * Contributing to new project proposals and survey instrument design * Conducting interviews and surveys with physicians, patients, and/or managed care decision makers * Overseeing data collection process * Analyzing data, and developing and presenting high-value client deliverables * Working closely with internal team members: * Leading project teams * Training and managing Research Analysts * Evolving our current product offerings with cutting edge ideas that meet our clients' developing needs * Developing client relationships The ideal applicant is driven to help shape the healthcare landscape and biopharmaceutical industry, motivated to achieve success in consulting, and aspiring to grow and develop with the practice. Strong candidates possess an inquisitive nature and a proven ability to produce high-value and strategic evidence-based market research consulting. Additionally, candidates should exhibit: * Record of academic excellence and work performance * BA/BS and relevant work experience; or, * Advanced degree (preferably in the sciences, healthcare, applied research, or business * Minimum of 5 years in qualitative or quantitative market research * Experience with survey methodology, statistical analysis and reporting, qualitative interviewing, group moderating, and in-person presentations * Preferred experience in pharmaceuticals, biotechnology, or other aspects of the healthcare industry * Pride and ownership in all work efforts and products * Excellent oral and written communication and confident presentation skills * Effective and efficient multitasking * Flexible skill set and work style that thrives in doing both independent tasks and contributes to a team environment * Prior experience leading project teams and managing research analysts * Holds the highest standard of personal professionalism and work integrity * Available for up to 25% travel Beyond these criteria, well-rounded individuals who will engage their colleagues professionally and contribute to a collegial office culture are encouraged to apply.2012-04-13 08:56:35United StatesQuintilesMassachusetts1205699MABoston, MA27876002http://quintiles.jobs/xml/27876002/jobUSAResearch Triangle ParkTitle: Programmer Analyst Location: USA-North Carolina-Research Triangle Park Other Locations: THIS POSITION CAN BE HOMEBASED PURPOSE Provide technical assistance as part of a team to develop and maintain clinical systems that meet internal and external clients' needs. Plan and coordinate database design and development for local, regional, or transnational use. THIS POSITION CAN BE HOMEBASED. RESPONSIBILITIES * Plan and coordinate design, development, implementation, maintenance of data integration and mapping activities * Provide technical expertise in conjunction with internal and external clients. * Program, test, and document databases in accordance with programming standards and validation procedures. * May assist IT in developing and implementing new technologies. * May assist IT in testing and evaluating new upgrades to technologies. * May assist in developing, revising, and maintaining core operating procedures and working instructions. * Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables. * Develop and maintain good communications and working relationships with teams and external clients. * May interact with corporate team and CDM team members to negotiate timelines, responsibilities, and deliverables. * May serve as Lead Programmer on the corporate team. REQUIREMENTS * Clinical Data Programming: Good knowledge of Oracle and/or SAS * Solid understanding of clinical drug development process * Min 2 years experience in clinical drug development industry * Min 2 years experience with CDISC SDTM mapping (multiple studies and multiple therapeutic areas) * Excellent organizational, communication, and technical database skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE BS degree or educational experience in computer/life science or related field with 1 year of relevant work experience. PHYSICAL REQUIREMENTS * Extensive use of telephone and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time2012-04-12 09:16:57United StatesQuintilesNorth Carolina1205494NCResearch Triangle Park, NC27839141http://quintiles.jobs/xml/27839141/jobUSANoneTitle: Associate CPM Director / CPM Director - Internal Medicine (US or EU) Location: United States Other Locations: Italy, Spain, Belgium, France, Germany, Ireland, Great Britain Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The position can be based in the US or EU. PURPOSE We are recruiting for anAssociate Clinical Project Management Director/Clinical Project Management Director specializing in Internal Medicine and Hemophilia studies within our Clinical Project Management Departmentto manage the execution of the assigned multi-regional study(ies), which may include study management, clinical and other functions per Contract, from initiation through to closeout. Ensure that all study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES ? Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects. ? Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to. ? Define, develop and implement study management plans, together with team assignments and accountabilities. ? Supervise team performance against contract, customer expectations, and project baselines. Develop recommendations for issue resolution for management and Sponsors. ? Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate clinical risk. ? Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings and own the implementation of appropriate corrective action plans. Manage and oversee the escalation of findings and action plans to appropriate parties. ? Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles. Ensure that Sponsor feedback is communicated and conveyed to other functional groups and action is initiated to address. ? Participate in proposal development, influence the scope and budget development of proposals for new work, including the study management costs. Escalate out of scope requests to management. ? Provide input to line managers of their project team members' performance relative to project tasks. Recommend team members' further professional development. Support staff development. Mentor less experienced CPMs. ? Prepare and present project information at internal and external meetings. Lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff. ? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 10 years' clinical research experience including 6 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES ? In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines ? In depth therapeutic and protocol knowledge ? Excellent communication and interpersonal skills, including good command of English language ? Excellent organizational and problem solving skills ? Track record of ability to work through others to deliver results to the appropriate quality and timeline metrics ? Good team leadership skills ? Effective mentoring and training skills ? Excellent customer service skills ? Good judgment ? Effective presentation skills ? Ability to manage competing priorities ? Demonstrated ability in project financial tracking and accounting methods and skill in applying them ? Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management ? Strong software and computer skills, including MS Office applications ? Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-04-12 09:16:12United StatesQuintilesNone1205638NoneVirtual, USA27839130http://quintiles.jobs/xml/27839130/jobUSABostonTitle: Clinical Research Associate / CRA / Senior CRA / Northeast Region, Medical Device ~ Location: USA-Massachusetts-Boston Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We currently have an opening for a CRA with Medical Device or strong Cardiovascular monitoring experience. Can be located anywhere in the NE region. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience - Medical Device or Cardiovascular monitoring experience required -Customer service orientation - Sound knowledge of medical terminology and clinical monitoring process - In depth therapeutic and protocol knowledge as provided in company training -Ability to perform regionalized travel an average of 65%, depending on project needs - Excellent verbal and written communications skills - In depth therapeutic and protocol knowledge as provided in company training -Excellent interpersonal and organizational skills and attention to detail - Computer literacy, proficiency in MS Office2012-04-07 08:42:25United StatesQuintilesMassachusetts1205464MABoston, MA27725264http://quintiles.jobs/xml/27725264/jobUSAMadisonTitle: Clinical Research Associate / CRA / Sr CRA / Madison, Wisconsin~ Location: USA-Wisconsin-Madison Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs monitoring experience - Oncology experience Preferred - Must be located in the Madison, Wisconsin - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-04-07 08:42:23United StatesQuintilesWisconsin1205456WIMadison, WI27725245http://quintiles.jobs/xml/27725245/jobUSAResearch Triangle ParkTitle: Clinical Project Manager (CPM) / Sr. CPM/Associate CPM Director, CPM - CNS and Cardiovascular & Metabolic Therapeutic Delivery Units Location: USA-North Carolina-Research Triangle Park Other Locations: USA-New Jersey-Parsippany, USA-California-San Diego, USA-Kansas-Overland Park Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seekingClinical Project Managers (CPM) / Sr. Clinical Project Managers /Associate Clinical Project Management Directors to work with our CNS (Neurology & Psychiatry) and Cardiovascular & Metabolic Therapeutic Delivery Units. The CPM/Sr. CPM/Associate CPM Director will manage the execution of the assigned regionally-based clinical study(ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. * Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. * Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. * Collect information on team performance against contract, customer expectations, and project baselines. * Lead problem solving and resolution efforts to include management of risk, contingencies and issues. * Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. * Provide input for the development of proposals for new work and manage project budgets. * Provide input to line managers of their project team members' performance relative to project tasks. * Prepare and present project information at internal and external meetings. * Participate in proposal development and in the bid-defense process with guidance and supervision. * Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. Bachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines * Good therapeutic and protocol knowledge * Strong communication and interpersonal skills, including good command of English language * Good problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good teamwork skills * Excellent customer service skills * Good presentation skills * Good judgment * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-04-07 08:41:10United StatesQuintilesNorth Carolina1204502NCResearch Triangle Park, NC27724903http://quintiles.jobs/xml/27724903/jobUSATallahasseeTitle: Pharmaceutical Sales Representative, Entry Level - Tallahassee, FL 6579 Location: USA-Florida-Tallahassee Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Entry LevelPharmaceutical Sales Representativesto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting Alcon, the global leader in eye care. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. Pharmaceutical Sales Representative The Pharmaceutical Representative targets, promotes and sells over the counter products to specialists in assigned therapeutic area. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Pharmaceutical Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. This is an outstanding entry level opportunity for a college graduate to break into the pharmaceutical market with an industry leader! Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required. · Business-to-Business sales experience strongly preferred. · Demonstrated leadership in community, professional and/or college organizations · Strong verbal, interpersonal and listening skills · Demonstrated self-starter and highly motivated · Demonstrated ability to work as a team member and effectively communicate within different levels of an organization · Demonstrated ability to work independently to deliver results · Demonstrated technical aptitude and computer skills essential Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-04-07 08:41:00United StatesQuintilesFlorida1205445FLTallahassee, FL27724876http://quintiles.jobs/xml/27724876/jobUSADallasTitle: Clinical Educator, Oncology/Infusion Specialty - Dallas, TX - 4425 Location: USA-Texas-Dallas Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for ClinicalEducatorswith experience in oncology and/or hematology and/or infusion to join our team of over 10,000 global field representatives in several regions for our pharmaceutical and biotech clients. In this role you will be supporting a major pharmaceutical company by educating peers on a product utilized in the hematology/oncology disease state. Clinical Educator - Oncology/Infusion Specialty The Clinical Educator - Oncology/Infusion Specialty provides education to their peers in transfusion centers to gain a better understanding of patients at risk for chronic iron overload and implementation of processes to identify patients at risk. Education is also presented to help staff have a better understanding of disease state treatments and proper dosing and administration of these treatments. This education is provided through formal presentation, round table discussion and individual interactions. This is a field based employee. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · RN with a 4 year Bachelor's degree required, masters degree preferred · Oncology and/or Hematology and/or Infusion Nurse specialist with health educator experience required · Oncology Certified Nurse preferred · Current license in good standing · Minimum of 3-5 years of Hematology/Oncology clinical experience · Transfusion experience required; blood bank experience may be considered with clinical background · Excellent teaching skills · Strong interpersonal skills, with demonstrated effectiveness working independently and on cross-functional teams · Excellent organizational skills · Experience in delivering service solutions desirable · Ability to manage multiple tasks · Willingness to travel · Excellent written and oral skills · Excellent presentation skills · Enthusiastic, good attitude, and ability to motivate others2012-04-07 08:40:44United StatesQuintilesTexas1205458TXDallas, TX27724781http://quintiles.jobs/xml/27724781/jobUSANoneTitle: Clinical Research Associate / CRA / Sr CRA / South Central* Location: USA-Texas Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. We are offering Sign On Bonuses! - BS/BA required. - 2 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:11United StatesQuintilesTexas1205217TXTexas, USA27635601http://quintiles.jobs/xml/27635601/jobUSADenverTitle: Clinical Research Associate / CRA / Sr. CRA - Denver / Salt Lake City* Location: USA-Colorado-Denver Other Locations: USA-Utah-Salt Lake City Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Denver, CO or Salt Lake City, Utah! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - BS/BA required. -2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Diabetes or Neuroscience experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:10United StatesQuintilesColorado1205223CODenver, CO27635600http://quintiles.jobs/xml/27635600/jobUSACambridgeTitle: Manager, Clinical Operations - Outcome Location: USA-Massachusetts-Cambridge Other Locations: Title: Clinical Research Associate (CRA) Manager Reports to: Associate Director of Clinical Operations or above Purpose: The CRA Manager will participate in the planning, design and execution of clinical studies to ensure quality, safety, and effectiveness of the Client's products and work collaboratively with internal and external project team members. Primary Responsibilities: § Directly manages Lead CRA/CRA study team(s), including Regional CRA selection and interview process, performance reviews, and adherence to monitoring plan. § Trains and mentors less experienced Clinical Research Associates. § Responsible for overall conduct and Site Management of multiple clinical studies § Establish and maintain primary communication with clinical sites and acts as client liaison to resolve any site related issues quickly and effectively. § Assists in the site/investigator selection system/process and in the identification/evaluation of Investigators and sites. § Assists in the completion of study related documents including informed consent form, protocol, Case Report Forms, template source documents, training manuals, regulatory binder, and other resource materials, clinical site and confidentiality agreements. § Independently conducts all types of monitor visits, qualifying site assessments, initiation, interim and closeout. § Provide internal project team and Client study specific monitoring metrics and track and report study site progress. § Manage all aspects of investigative sites from start-up to close out including providing Investigator and study staff training as needed. § Participate in investigator, coordinator and team meetings. § Provide site support, communication and coordination to assure accurate and timely completion of all contracted activities. § Facilitate general communication among the research centers, project teams, sponsors and site monitors relative to the responsibilities itemized above. * Requirements: § B.S. Degree in science/health related field required; Masters or Nursing Degree preferred. § Minimum of 2 years clinical research experience required in a pharmaceutical, biotech or CRO setting. § Approximately 10-25% travel may be required, to attend Investigator Meetings, Site Visits, Professional Conferences § Ability to work independently and in a team environment. § Must have strong interpersonal skills to be able to communicate both verbally and in writing with internal and external clients. § Must be able to prioritize multiple, competing tasks with excellent organizational skills. Needs to pay high attention to detail. § Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint) and Internet communication2012-04-04 08:18:08United StatesQuintilesMassachusetts1205211MACambridge, MA27635595http://quintiles.jobs/xml/27635595/jobUSAResearch Triangle ParkTitle: Director, Clinical Project Management (Late Phase) Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Direct and manage an assigned team of clinical project management staff who manage or support Phase IIIB/IV studies or programs to ensure quality, time and budget deliverables are met to the Sponsor's satisfaction. Work with staff to ensure that all Phase IIIB/IV study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. Ensure that employees are trained and individual development is aligned and in place to meet project and organizational needs. Provide support and input into the organizational infrastructure building to accommodate scalable growth. RESPONSIBILITIES · Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters · Actively provide guidance and review of the scope of work, objectives, timelines, quality of deliverables, and other clinical project management activities for studies and programs. · Coach and mentor employees around project planning, project review, risk management and problem solving to ensure global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees. · Work with the clinical project managers to ensure that project budget(s) meet financial and company goals (realization targets), with a focus on proactively ensuring adherence to change control processes. · Obtain and provide regular feedback to employees from other clinical project team members and key stakeholders to assist in personal and professional development. May attend project team meeting and site visits in order to support development needs. Identify skill and competency gaps at the individual level and work to craft appropriate development plans. · Proactively manage risks linked to resourcing, project and/or individual needs with other management and leadership team members to manage study issues and obstacles. · Act as a key relationship manager for assigned clients; recommend courses of action regarding client management issues; ensure that plans are implemented following approval by senior management. · Working with individual staff to identify any quality issues within the study and coaching on resolution of issues, including implementation of corrective action plans and escalation. · May act as point of contact or oversight for specific customers or programs. · Provide technical expertise and clinical project management experience to project management and training and process improvement efforts. · Serve as a project management liaison with other groups within Quintiles. · Provide consultation to clients on drug development process, strategy, and plans as needed. · Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · In depth knowledge of, and skill in applying, applicable Phase IIIB/IV clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines · Excellent communication and interpersonal skills, including good command of English language · Excellent organizational and problem solving skills · Effective team-management skills · Proven ability to work through others to deliver results to the appropriate quality and timeline metrics · Effective mentoring and training skills · Ability to balance operational and strategic priorities · Excellent customer service skills · Good judgment and decision making skills · Good understanding of other Quintiles functions and their inter- relationship with Clinical Project Management · Strong software and computer skills, including MS Office applications · In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes · Knowledge of project financial tracking and accounting methods and skill in applying them · Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 12 years' clinical research experience including 8 years' leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience. PHYSICAL REQUIREMENTS · Extensive use of keyboard requiring repetitive motion of fingers. · Extensive use of telephone and face-to-face communication requiring accurate perception of speech. · Regular sitting for extended periods of time. · May require occasional travel.2012-04-04 08:18:08United StatesQuintilesNorth Carolina1205212NCResearch Triangle Park, NC27635598http://quintiles.jobs/xml/27635598/jobUSALittle RockTitle: Clinical Research Associate / CRA / Sr. CRA - Little Rock* Location: USA-Arkansas-Little Rock Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Little Rock, AR! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - BS/BA required. -2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:07United StatesQuintilesArkansas1205242ARLittle Rock, AR27635593http://quintiles.jobs/xml/27635593/jobUSADenverTitle: Clinical Research Associate / CRA / Sr. CRA - Denver / Salt Lake City* Location: USA-Colorado-Denver Other Locations: USA-Utah-Salt Lake City Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Denver, CO or Salt Lake City, Utah! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - BS/BA required. -2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:06United StatesQuintilesColorado1205244CODenver, CO27635592http://quintiles.jobs/xml/27635592/jobUSADallasTitle: Clinical Research Associate / CRA / Sr. CRA - Dallas* Location: USA-Texas-Dallas Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Dallas, TX! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Prefer BS/BA. - 2yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:06United StatesQuintilesTexas1205246TXDallas, TX27635591http://quintiles.jobs/xml/27635591/jobUSAAustinTitle: Clinical Research Associate / CRA / Sr. CRA - Austin* Location: USA-Texas-Austin Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Austin, TX! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Prefer BS/BA. - 2yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:06United StatesQuintilesTexas1205247TXAustin, TX27635590http://quintiles.jobs/xml/27635590/jobUSAHoustonTitle: Clinical Research Associate / CRA / Sr. CRA - Houston* Location: USA-Texas-Houston Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Houston, TX! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - BS/BA required. -2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:05United StatesQuintilesTexas1205229TXHouston, TX27635589http://quintiles.jobs/xml/27635589/jobUSAPhoenixTitle: Clinical Research Associate / CRA / Sr. CRA - Phoenix / Tucson~ Location: USA-Arizona-Phoenix Other Locations: USA-Arizona-Tuscon Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Phoenix, AZ or Tucson, AZ! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Prefer BS/BA. - 3yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:04United StatesQuintilesArizona1205231AZPhoenix, AZ27635588http://quintiles.jobs/xml/27635588/jobUSAShreveportTitle: Clinical Research Associate / CRA / Sr. CRA - Shreveport* Location: USA-Louisiana-Shreveport Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Shreveport, LA! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Prefer BS/BA. - 2yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:03United StatesQuintilesLouisiana1205234LAShreveport, LA27635584http://quintiles.jobs/xml/27635584/jobUSASan AntonioTitle: Clinical Research Associate / CRA / Sr. CRA - San Antonio / Dallas / Houston Location: USA-Texas-San Antonio Other Locations: USA-Texas-Houston, USA-Texas-Dallas Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for San Antonio, Dallas or Houston, TX! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - BS/BA required. - 2yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience preferred. - Phase I experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:03United StatesQuintilesTexas1205237TXSan Antonio, TX27635587http://quintiles.jobs/xml/27635587/jobUSAChicagoTitle: Clinical Research Associate / Sr CRA - North Central Region* Location: USA-Illinois-Chicago Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. This is a homebased CRA opportunity that can be based anywhere in the North Central Region. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - BS/BADegree - At least1 yr monitoring or study coordinator equivalent -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:02United StatesQuintilesIllinois1205268ILChicago, IL27635577http://quintiles.jobs/xml/27635577/jobUSADallasTitle: Clinical Research Associate / CRA / Sr. CRA - Dallas / Houston* Location: USA-Texas-Dallas Other Locations: USA-Texas-Houston Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Dallas or Houston, TX! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Prefer BS/BA. - 2yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Neuroscience or diabetes experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-04 08:18:01United StatesQuintilesTexas1205160TXDallas, TX27635575http://quintiles.jobs/xml/27635575/jobUSACambridgeTitle: Director, Software Applications Engineering Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. The Director, Engineering will lead EDC client customized application solutions development teams. As part of a services organization, in this role, s/he is responsible for the planning, development, and delivery of the client focused, customized applications and solutions within budget and on time with a high degree of quality. As well as, provide leadership and oversight to all application development resources, execution of development processes and metrics collection and reporting including the implementation of development process improvements necessary to gain further efficiencies, scalability and quality. Responsibilities: * Manage the EDC client customized application development teams with dotted-line reporting of the Software Quality Assurance team to ensure on time, within budget, quality releases * Provide leadership to team managers and team leads, and motivate, delegate and develop a strong development team that is flexible and committed to the goals of the organization * Deliver all client focused applications and solutions on time, on budget, and within quality standard targets * Review and inspect development team project plans and estimates ensuring consistency and accuracy * Monitor resource utilization and capacity ensuring efficiency and forecast future capacity needs working closely with CTS to ensure staffing availability to deliver projects as, when needed * Management by metrics - Implement standard department metrics to enable measuring productivity, quality and progress and managing to meet goals and objects set * Drive continuous process improvements and efficiencies across application development teams * Conduct "lessons learned" evaluations for all major projects and champion change initiatives based on retrospective outcomes * Communicate effectively, set expectations, and work cohesively with related departments such as Software Quality Assurance, Client Technical Solutions, and Project Management * Follow documented Development Standard Operating Procedures and Working Practices, and suggest and make changes to procedures where appropriate * Recruit and hire high quality candidates; motivate team and retain key performers Requirements: * 10 years experience in hosted software delivery * A minimum of 5 years managing multiple software delivery teams/projects * Proven success in leading technical teams * Technical experience as a software developer * Ability to manage multiple parallel projects, highly organized with great attention to detail * Must have strong communication skills (both verbal and written) * Client service focused, with direct experience interacting with clients and end users preferred * Experience with Oracle, Linux , and hosted web application development using Apache, Tomcat, and Java * Experience with database intensive, high performing, scalable application development * Knowledge of FDA 21 CFR Part 11 regulations regarding electronic records preferred * Experience within the healthcare industry preferred * Bachelor's degree; MS preferred2012-04-04 08:17:59United StatesQuintilesMassachusetts1205254MACambridge, MA27635574http://quintiles.jobs/xml/27635574/jobUSACambridgeTitle: Release Project Coordinator - Outcome/Cambridge, MA Location: USA-Massachusetts-Cambridge Other Locations: This is an entry level position which is located in Cambridge, MA - relocation assistance is not available. Purpose: The Release Project Coordinator reports to and works with Release Project Manager to assist in managing the release software projects. This role is involved in all parts of the process, including estimation, scheduling, and implementation. This new position will contribute to growing the newly created department of Release Management within Engineering. Responsibilities: · Own regular status communications to the project stakeholders as well as to the Global Professional Services organization · Communicate directly with the Professional Services, Data Management and all other project team members regarding upcoming deliverables and milestones · Manage metric documentation · Assist in overseeing release status, including identifying and mitigating risks · Enforce and educate on the processes of software project lifecycle which include estimation, scheduling, and implementation from various teams · Be a point of contact for stakeholders regarding project plans and status Requirements: · Bachelor's degree or higher · Very strong verbal and written communication skills · Must be very detail-oriented and organized · 3 or more years of experience in project management · Experience working with clients (internal or external) with varying levels of technical expertise · Experience working in a fast-paced, dynamic environment (software development environment preferred) · Experience with waterfall and iterative, agile product development · Excellent MS Project skills · Familiar with JIRA desired · Experience in clinical/biotech industry a plus2012-04-02 08:52:50United StatesQuintilesMassachusetts1205021MACambridge, MA27575985http://quintiles.jobs/xml/27575985/jobUSARaleighTitle: CRA / Sr CRA - NORTH CAROLINA ~ Location: USA-North Carolina-Raleigh Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Minimum BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-02 08:52:26United StatesQuintilesNorth Carolina1205090NCRaleigh, NC27575983http://quintiles.jobs/xml/27575983/jobUSARaleighTitle: CRA / Sr CRA - GEORGIA ~ Location: USA-North Carolina-Raleigh Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Minimum BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-02 08:52:26United StatesQuintilesNorth Carolina1205091NCRaleigh, NC27575982http://quintiles.jobs/xml/27575982/jobUSARaleighTitle: CRA / Sr CRA - SOUTH CAROLINA ~ Location: USA-North Carolina-Raleigh Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Minimum BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-02 08:52:26United StatesQuintilesNorth Carolina1205092NCRaleigh, NC27575981http://quintiles.jobs/xml/27575981/jobUSARaleighTitle: CRA / Sr CRA - FLORIDA ~ Location: USA-North Carolina-Raleigh Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Minimum BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-02 08:52:25United StatesQuintilesNorth Carolina1205093NCRaleigh, NC27575980http://quintiles.jobs/xml/27575980/jobUSARaleighTitle: CRA / Sr CRA - TN ~ Location: USA-North Carolina-Raleigh Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Minimum BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-04-02 08:52:25United StatesQuintilesNorth Carolina1205094NCRaleigh, NC27575979http://quintiles.jobs/xml/27575979/jobUSAResearch Triangle ParkTitle: Medical Director/Senior Medical Director - Oncology TDU Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta, USA-Maryland-Rockville, USA-New Jersey-Parsippany, USA-California-San Diego, USA-Kansas-Overland Park The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiasticMedical Director/Senior Medical Director within our Oncology Therapeutic Delivery Unit to join our team! The Medical Director/Senior Medical Director will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbent will participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES •Serves as Regional Medical Advisor and/or Global Medical Advisor on assigned projects. •Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. •Performs review and clarification of trial-related Adverse Events (AEs). •Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives. •Provides medical support for the Analysis Of Similar Events (AOSE). •Performs medical review of Adverse Event coding. •Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). •Performs medical review of the Clinical Study Report (CSR) and patient narratives. •Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at the investigative sites. •Attends and presents at the Investigator Meeting(s). •Provides therapeutic area/indication training for the project clinical team. •Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. •Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. •Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. •Participates in the development of Medical & Scientific Services portion of client proposals including the budgeting process. •Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. •Budget responsibility for large global multi-million dollar programs; responsible for all safety issues on these programs. •Provides expert consultation to NovaQuest, the Partnering Group of Quintiles Transnational, and supports the due diligence research of select compounds and/or companies as requested. •Serves as Regional Medical Director and/or Global Therapeutic Head for larger teams and/or regions. •Participates in management level meetings within Medical & Scientific Services. •Supervises Medical and Scientific Services Staff with assigned direct reports and provides mentoring as required. •Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff. •Recommends course of action on management/human resources matters, including salary administration, transfers, hiring, terminations, professional development, performance appraisals, and employee counseling. •Identifies ongoing training and development needs of assigned staff. •Evaluates assigned staff workload and creates volume projections in order to ensure appropriate balance of project assignments for direct reports. •Maintains awareness of industry developments and participates in professional meetings, and may author related publications. •Performs special projects as requested by management. A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required, plus a minimum of 5 years experience in clinical medicine, in addition to 12 years clinical development experience in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience.2012-04-02 08:52:12United StatesQuintilesNorth Carolina1205081NCResearch Triangle Park, NC27575972http://quintiles.jobs/xml/27575972/jobUSAResearch Triangle ParkTitle: Senior IT Business Analyst / Lead IT Business Analyst Location: USA-North Carolina-Research Triangle Park Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our IT Business Analyst position located in our Morrisville, NC office. . Primary Responsibilities: * Perform enterprise requirements gathering and analysis in order to document high quality, detailed requirements and business rules * Gather, validate and document data requirements in direct support of business requirements and priorities for Data Factory related projects * Resolve conflicting end-user requirements * Model processes to clarify business requirements, and to enhance or re-engineer business processes, prior to solution design and implementation, as necessary * Daily collaborations with business end users, IT Data Architects, IT Data Analysts or IT Testers serving as a Product / Business / Process / Data SME * Identification of data sources for the required data attributes and understanding/establishment of business processes to ensure data quality in source systems * Maintain current knowledge of data relationships, system interfaces and business processes supporting data entry procedures * Create User Test Cases that explicitly address each identified requirement and facilitate User Testing * Document/maintain all requirements in Top Team, and publish approved requirements into Quality Center * Follow Quintiles System Life-Cycle (SLC) and Computer System Validation (CSV) procedures, as appropriate * Identify initial Business Case requirements & other pre-project activities (e.g., high-level requirements, project scope, objectives) * Assist in on-going evaluation of current and new business data requirements to achieve higher operational efficiencies and project portfolio alignment * Evaluate potential expansion projects, provide data requirements and design for new releases, as necessary * Other duties as assigned Required Knowledge, Skills and Abilities * 7 years of business analysis experience * Strong analytical, organizational, verbal communication, business writing, and project management skills. * Excellent communication skills * Understanding of SDLC processes * Working knowledge of data quality management principles and best practices * Experience in development implementations Preferred * CRO/Pharmaceutical background * Change Management, Process Improvement Certifications * Proven abilities to effectively Mentor, Train or Coach matrix team members2012-03-30 08:06:14United StatesQuintilesNorth Carolina1205027NCResearch Triangle Park, NC27510645http://quintiles.jobs/xml/27510645/jobUSAResearch Triangle ParkTitle: Associate Director, IPT - User Groups Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Integrated Processes and Technologies (IPT) provides cross-functional solutions integrating people, processes and technologies in order to make effective business decisions. Define and lead project activities within IPT that are global in nature, working cross-functionally on activities that have a broad impact and a high level of complexity. Will create plans and gain full organizational support. Specifically, within the Quintiles Infosario team, lead product user groups and support model for internal and external customers. RESPONSIBILITIES · Schedule, coordinate and dirve user support initiatives for individual project teams and external customers. Leverage the role of the business champions to optimize adoption of Quintiles Infosario Reporting and Analytics and Data Driven Processes · Drive change and adoption efforts across the organization and is an active advocate, both within function and cross-functionally. · Define and ensure the adoption of a strategy for a scalable user support solution, collaborating with the Call Center, O&SA, IT and other relevant groups · Create and manage the execution of internal and external user input / feedback collection channels including but not limited to focus groups, automated polling, surveys, in coordination with marketing team and change management work stream, and communicate feedback and recommendations to the core work stream team. · Actively represent the user community in the ongoing maturation of Quintiles Infosario by driving the development and testing efforts of new visualizations, in coordination with the user experience work stream · Ensure the overall data quality visualized in Quintiles Infosario through regular investigation of visualizations and collaboration with the Data Sources and Quality and Process Design work streams to ensure ongoing improvement of data and processes · Investigate quality issues and risks and their impact. Resolve quality issue escalations and ensure preventive measures are implemented in a timely manner. Identify and manage all project risks and issues and develop and execute effective contingency plans. · Develop work plans in conjunction with all stakeholders. Monitor variance and report project status on an ongoing basis. · Lead project activities or participate in special assignments with broad organizational impact. · Assist in preparation, review and present project updates for internal (and external as appropriate) audiences. · Mentor, support and guide the work and output of other team members. · Ensure project strategy and delivery aligns with strategic objectives and is able to articulate how project strategy aligns with strategic objectives. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Comprehensive domain knowledge of all functions that are engaged during the clinical trial process · Advanced knowledge of SOPs, GCPs, related regulatory requirements and systems or process requirements as well as the inter-workings of the Clinical Development Business · Excellent computer literacy, organizational, communication and problem-solving skills · Proven ability to work effectively through others in a global environment to deliver results · Effective leadership skills in a matrix environment, able to guide and manage junior staff · Good risk management skills using key metrics and performance data · Demonstrated understanding and application of business strategy · Excellent customer service skills · Strong judgment and decision making skills MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree, or educational equivalence, in clinical, biological or mathematical sciences, business or related field with 10 years experience in a clinical research environment, including project management experience, clinical operations, or data management, with specific knowledge of clinical systems or equivalent combination of education, training and experience PHYSICAL REQUIREMENTS · Extensive use of telephone and face-to-face communication requiring accurate perception of speech · Extensive use of keyboard requiring repetitive motion of fingers · Regular sitting for extended periods of time2012-03-30 08:06:13United StatesQuintilesNorth Carolina1202667NCResearch Triangle Park, NC27510643http://quintiles.jobs/xml/27510643/jobUSAResearch Triangle ParkTitle: Associate Medical Director/Medical Director - General Medicine/Internal Medicine, Pulmonary/Respiratory (refer to #1111616) Location: USA-North Carolina-Research Triangle Park Other Locations: The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiasticAssociate Directors/Medical Directors within General Medicine/Internal Medicine and Pulmonary/Respiratoryto join our team! The Associate Director/Medical Director will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbent will participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES * Serves as Regional Medical Advisor and/or Global Medical Advisor on assigned projects. * Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. * Performs review and clarification of trial-related Adverse Events (AEs). * Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives. * Provides medical support for the Analysis Of Similar Events (AOSE). * Performs medical review of Adverse Event coding. * Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). * Performs medical review of the Clinical Study Report (CSR) and patient narratives. * Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at the investigative sites. * Attends and presents at the Investigator Meeting(s). * Provides therapeutic area/indication training for the project clinical team. * Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. * Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. * Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. * Participates in the development of Medical & Scientific Services portion of client proposals including the budgeting * process. * Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. * Budget responsibility for large global multi-million dollar programs; responsible for all safety issues on these programs. * Provides expert consultation to NovaQuest, the Partnering Group of Quintiles Transnational, and supports the due diligence research of select compounds and/or companies as requested. * Serves as Regional Medical Director and/or Global Therapeutic Head for larger teams and/or regions. * Participates in management level meetings within Medical & Scientific Services. * Supervises Medical and Scientific Services Staff with assigned direct reports and provides mentoring as required. * Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff. * Recommends course of action on management/human resources matters, including salary administration, transfers, * hiring, terminations, professional development, performance appraisals, and employee counseling. * Identifies ongoing training and development needs of assigned staff. * Evaluates assigned staff workload and creates volume projections in order to ensure appropriate balance of project * assignments for direct reports. * Maintains awareness of industry developments and participates in professional meetings, and may author related * publications. * Performs special projects as requested by management. A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the works is required, plus a minimum of 5 years experience in clinical medicine, in addition to 1-2 years clinical development experience in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience. * Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs * Ability to establish and meet priorities, deadlines, strategic department goals and objectives. * Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-03-30 08:05:29United StatesQuintilesNorth Carolina1204992NCResearch Triangle Park, NC27510635http://quintiles.jobs/xml/27510635/jobUSABostonTitle: Pharmaceutical Sales Representative, Entry Level Boston,MA 6579 Location: USA-Massachusetts-Boston Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Entry LevelPharmaceutical Sales Representativesto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role you will be supporting Alcon, the global leader in eye care. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. Pharmaceutical Sales Representative The Pharmaceutical Representative targets, promotes and sells over the counter products to specialists in assigned therapeutic area. They manage their territory in order to maintain existing physician groups and develop relationships with new physician groups to achieve customer objectives. The Pharmaceutical Sales Reps will provide quality consultative service, coordinate and integrate outside alliances, internal personnel & resources to fit customer needs while building positive relationships targeted at increasing market share and exceeding customer set quotas. This is an outstanding entry level opportunity for a college graduate to break into the pharmaceutical market with an industry leader! Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required. · Business-to-Business sales experience strongly preferred. · Demonstrated leadership in community, professional and/or college organizations · Strong verbal, interpersonal and listening skills · Demonstrated self-starter and highly motivated · Demonstrated ability to work as a team member and effectively communicate within different levels of an organization · Demonstrated ability to work independently to deliver results · Demonstrated technical aptitude and computer skills essential Competencies · Demonstrated analytical skills · Demonstrated business acumen · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Initiative & execution-oriented · Teamwork2012-03-28 08:26:52United StatesQuintilesMassachusetts1204895MABoston, MA27440871http://quintiles.jobs/xml/27440871/jobUSAChicagoTitle: Clinical Project Manager/ Sr Clinical Project Manager - Home Based Location: USA-Illinois-Chicago Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. With supervision from Management, the Project manager (PM) role is to implement agreed upon strategies for the management of national or international internet-based outcome studies with pre-specified timelines and budgets. The PM leads the project team and is responsible for the successful conduct and completion of the project to the contracted budge and timelines and for ensuring the quality of the project according to ICH/GCP (if applicable), Outcome and/or Sponsor SOPs, guidelines and requirements. In addition, the PM will serve as the point of contact for internal/external customers and act as the liaison to the Sponsor for study-related issues. Supports Business Development and acts as a mentor or supervisor for less experienced clinical operations staff. Primary Responsibilities: Leads projects that may include monitoring, EDC development (production and maintenance,) data management, programming, safety, statistics, report/protocol writing, medical affairs and agency presentations and ensure these requirements are properly documented. Manages and supports project goals within Clinical Operations including startup activities focused around site identification, contract (CTA) and budget, patient recruitment, enrollment and monitoring plans, marketing and public relations campaigns per the project plan and associated timelines. Within a matrix environment, coordinate and manage all deliverables, milestones and deadlines related to assigned studies/projects, including site enrollment, regulatory and IRB/EC approvals, and patient enrollment and follow-up. Provide the Clinical Site Management team with the information and tools needed to ensure their ability to support the program both initially and throughout the project duration. Work closely with the cross functional teams (such as Development, Quality Control, Data Management, Statistics) to lead resources during the design, development, testing and implementation phase of EDC, including answering questions and clarifying requirements for the clinical design Act as customer advocate throughout the project lifecycle. Serve as the liaison between the clients and internal team to ensure project-specific information and ongoing updates are proactively communicated. Assure that meeting minutes and communication of decisions and action items are documented appropriately in minutes. Firm understanding the contractual obligations to each client and ensure those responsibilities are met (with the goal to exceed those expectations). Supports the development and review of the proposal and budget to align with the SOW. Understand client’s expectations for the study and define project requirements, deliverables, schedules and budgets. Identify out-of-scope tasks and client requests per change management and support and/or the development of Change Orders that align with Sponsor expectations. Provides monthly status reports to sponsor and/or internal purposes, financial reports requirements utilizing corporate reporting tools (PSR Meetings), Invoice Generation and revenue review (ETC and Project Margin), Timesheet review, and pass-through cost review as applicable. Guide client through EDC configuration and customization decisions including driving the software features versus cost/schedule trade-off decisions with the client. Ability to understand and offer customization options that align with the technical group's capabilities. This includes managing internal resourcing ageist client timelines and user requirements. Identify and implement strategic opportunities to enhance and improve the project (e.g., site retention activities). This includes risk management, contingency planning, enrollment strategies that will support the project objectives. Develop, Review and/or maintain clear study related documents, including supporting system specifications that require technical writing. Ensures all critical study documentation (i.e., DMP, Monitoring Plan, SAP, and Training) is collected and filed in TMF/eTMF so that we are audit ready. Manage the preparation, maintenance and traceability of central and site files (TMF/eTMF) for projects with the functional leads. Adhere to internal change management processes per our internal SOPs, WI and project specific process. Including project specific quality initials to assure that projects are audit ready. Coordination and management of external providers/vendors as applicable. Deliver presentations at internal staff meetings and to existing clients. Identify and support business development opportunities. Participate in the development, review and drafting of proposals and then participate in the bid defense meetings as required. Mentor and/or manage project management staff and other team members as applicable. This job description may include additional individual duties and responsibilities not listed in detail but still expected to be reasonably performed. Home-based experience preferred We are open to candidates located anywhere in the US Bachelors degree with 3 or more years of Project Management experience in the health care, medical research, CRO or healthcare technology setting. Knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and understanding of the clinical development process (Phase I-IV, post marketing, abstraction protocols and/or REMS). Excellent time management and organizational skills, able to produce high quality work independently or as part of a team, be able to multi-task and work in a high volume, deadline controlled environment. The ability to learn quickly, multi-task and prioritize are essential. Must be proficient in MS Office applications. Management or mentoring experience a plus. Must be hard-working and have the ability to work very independently. Problem solving skills; very strong written, verbal communication skills. Leadership skills in an international environment and customer service oriented. Demonstrated success in Project Management. Ability to travel and attend international meeting.2012-03-28 08:25:48United StatesQuintilesIllinois1204808ILChicago, IL27440851http://quintiles.jobs/xml/27440851/jobUSAWalnut CreekTitle: Area Business Specialist - Oakland - Stockton/Walnut Creek 7073 Location: USA-California-Walnut Creek Other Locations: USA-California-Stockton Our customers CNS division offers medications for the treatment of schizophrenia, schizoaffective disorder, bipolar and ADHD. The primary objective of the specialty representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required, Business or Science preferred · Minimum 4 years Pharmaceutical sales experience required · Proven track record of success in competitive selling environment · Demonstrated ability to sell in a complex reimbursement (Managed Care) environment is required · Reimbursement/"Buy and Bill" experience will be preferred · Ability to effectively prospect and identify additional business opportunities within territory · Experience working with institutions and mental health systems preferred · Strong verbal, interpersonal and listening skills · Demonstrated strong computer and analytical skills · Ability to travel overnight as required · Candidates must have a valid driver's license issued in one of the fifty states and meet with Quintiles MVR requirements · Residence within geography. Competencies • Business Acumen • Strategic • Collaborative • Consultative • Manages without authority2012-03-26 08:24:07United StatesQuintilesCalifornia1204752CAWalnut Creek, CA27381125http://quintiles.jobs/xml/27381125/jobUSANoneTitle: Area Business Specialist - Eastern Coast/NC Overlay - New Bern/Greenville 7073 Location: USA-North Carolina Other Locations: Our customers CNS division offers medications for the treatment of schizophrenia, schizoaffective disorder, bipolar and ADHD. The primary objective of the specialty representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required, Business or Science preferred · Minimum 4 years Pharmaceutical sales experience required · Proven track record of success in competitive selling environment · Demonstrated ability to sell in a complex reimbursement (Managed Care) environment is required · Reimbursement/"Buy and Bill" experience will be preferred · Ability to effectively prospect and identify additional business opportunities within territory · Experience working with institutions and mental health systems preferred · Strong verbal, interpersonal and listening skills · Demonstrated strong computer and analytical skills · Ability to travel overnight as required · Candidates must have a valid driver's license issued in one of the fifty states and meet with Quintiles MVR requirements · Residence within geography. Competencies • Business Acumen • Strategic • Collaborative • Consultative • Manages without authority2012-03-26 08:24:06United StatesQuintilesNone1204748NoneVirtual, USA27381123http://quintiles.jobs/xml/27381123/jobUSASan DiegoTitle: Pharmaceutical Sales Representative - CNS San Diego/Orange County, CA 6633 Location: USA-California-San Diego Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Pharmaceutical Sales Representative - CNS The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience ·4 year Bachelor's degree required, Business or Science preferred ·Minimum 2 years Pharmaceutical sales experience required ·Minimum 2 years CNS experience required ·Proven track record of success in competitive selling environment ·Experience in institutions and mental health clinics preferred ·Ability to effectively prospect and identify additional business opportunities within territory ·Strong verbal, interpersonal and listening skills ·Demonstrated strong computer and analytical skills ·Ability to travel overnight as required ·Candidates must have a valid driver's license issued in one of the fifty states and meet with Quintiles MVR requirements ·Preference will be given to candidates living within 30 miles of the posted geography. Competencies ·Demonstrated effective organizational and proactive problem solving skills ·Confidence in working in an environment of complexity and ambiguity ·Demonstrated self-starter and highly motivated ·Demonstrated ability to work as a team member and effectively communicate within different levels of an organization ·Demonstrated ability to work independently to deliver results ·Demonstrated leadership in community and/or professional organizations2012-03-26 08:24:06United StatesQuintilesCalifornia1204753CASan Diego, CA27381124http://quintiles.jobs/xml/27381124/jobUSASan AntonioTitle: Pharmaceutical Sales Representative - CNS San Antonio/Austin/South Texas 6633 Location: USA-Texas-San Antonio Other Locations: USA-Texas-Austin As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Pharmaceutical Sales Representative - CNS The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience ·4 year Bachelor's degree required, Business or Science preferred ·Minimum 2 years Pharmaceutical sales experience required ·Minimum 2 years CNS experience required ·Proven track record of success in competitive selling environment ·Experience in institutions and mental health clinics preferred ·Ability to effectively prospect and identify additional business opportunities within territory ·Strong verbal, interpersonal and listening skills ·Demonstrated strong computer and analytical skills ·Ability to travel overnight as required ·Candidates must have a valid driver's license issued in one of the fifty states and meet with Quintiles MVR requirements ·Preference will be given to candidates living within 30 miles of the posted geography. Competencies ·Demonstrated effective organizational and proactive problem solving skills ·Confidence in working in an environment of complexity and ambiguity ·Demonstrated self-starter and highly motivated ·Demonstrated ability to work as a team member and effectively communicate within different levels of an organization ·Demonstrated ability to work independently to deliver results ·Demonstrated leadership in community and/or professional organizations2012-03-26 08:24:05United StatesQuintilesTexas1204749TXSan Antonio, TX27381121http://quintiles.jobs/xml/27381121/jobUSAResearch Triangle ParkTitle: Associate Medical Director/Medical Director/Senior Medical Director - Rheumatology & Gastrointestinal (GI) Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta, USA-Maryland-Rockville, USA-New Jersey-Parsippany, USA-California-San Diego, USA-Kansas-Overland Park The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiasticAssociate Director/Medical Director/Senior Medical Director within Rheumatology & Gastrointestinal (GI)to join our team! The Associate Director/Medical Director/Senior Medical Director will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbent will participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES * Serves as Regional Medical Advisor and/or Global Medical Advisor on assigned projects. * Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. * Performs review and clarification of trial-related Adverse Events (AEs). * Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives. * Provides medical support for the Analysis Of Similar Events (AOSE). * Performs medical review of Adverse Event coding. * Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). * Performs medical review of the Clinical Study Report (CSR) and patient narratives. * Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at the investigative sites. * Attends and presents at the Investigator Meeting(s). * Provides therapeutic area/indication training for the project clinical team. * Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. * Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. * Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. * Participates in the development of Medical & Scientific Services portion of client proposals including the budgeting * process. * Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. * Budget responsibility for large global multi-million dollar programs; responsible for all safety issues on these programs. * Provides expert consultation to NovaQuest, the Partnering Group of Quintiles Transnational, and supports the due diligence research of select compounds and/or companies as requested. * Serves as Regional Medical Director and/or Global Therapeutic Head for larger teams and/or regions. * Participates in management level meetings within Medical & Scientific Services. * Supervises Medical and Scientific Services Staff with assigned direct reports and provides mentoring as required. * Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff. * Recommends course of action on management/human resources matters, including salary administration, transfers, * hiring, terminations, professional development, performance appraisals, and employee counseling. * Identifies ongoing training and development needs of assigned staff. * Evaluates assigned staff workload and creates volume projections in order to ensure appropriate balance of project * assignments for direct reports. * Maintains awareness of industry developments and participates in professional meetings, and may author related * publications. * Performs special projects as requested by management. A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the works is required, plus a minimum of 5 years experience in clinical medicine, in addition to 1-2 years clinical development experience in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience. * Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs * Ability to establish and meet priorities, deadlines, strategic department goals and objectives. * Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-03-26 08:24:04United StatesQuintilesNorth Carolina1204734NCResearch Triangle Park, NC27381116http://quintiles.jobs/xml/27381116/jobUSAPhiladelphiaTitle: Area Business Specialist - Philadelphia, PA 7073 Location: USA-Pennsylvania-Philadelphia Other Locations: Our customers CNS division offers medications for the treatment of schizophrenia, schizoaffective disorder, bipolar and ADHD. The primary objective of the specialty representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree required, Business or Science preferred · Minimum 4 years Pharmaceutical sales experience required · Proven track record of success in competitive selling environment · Demonstrated ability to sell in a complex reimbursement (Managed Care) environment is required · Reimbursement/"Buy and Bill" experience will be preferred · Ability to effectively prospect and identify additional business opportunities within territory · Experience working with institutions and mental health systems preferred · Strong verbal, interpersonal and listening skills · Demonstrated strong computer and analytical skills · Ability to travel overnight as required · Candidates must have a valid driver's license issued in one of the fifty states and meet with Quintiles MVR requirements · Residence within geography. Competencies • Business Acumen • Strategic • Collaborative • Consultative • Manages without authority2012-03-26 08:24:04United StatesQuintilesPennsylvania1204742PAPhiladelphia, PA27381117http://quintiles.jobs/xml/27381117/jobUSAManassasTitle: Lab Technician Location: USA-Virginia-Manassas Other Locations: The Laboratory Technician will conduct all aspects of sample and reference compound custodial programs by utilizing the Laboratory Information Management System as well as other commercial and in-house databases. The incumbent will perform routine instrument maintenance, system monitoring, and laboratory cleanliness and will utilize multiple databases to allow for tracking and scheduling of laboratory maintenance and processes, ensuring full GLP compliance. The incumbent will also provide support for supply allocation. The successful candidate must have a High School Diploma with 3 years' related experience; or equivalent combination of education, training and experience in a GLP analytical laboratory.2012-03-23 09:19:16United StatesQuintilesVirginia1204413VAManassas, VA27340796http://quintiles.jobs/xml/27340796/jobUSAMariettaTitle: *Assoc Lab Project Set-Up Manager / Lab Project Set-Up Manager Location: USA-Georgia-Marietta Other Locations: Quintiles Laboratories is a global Central Laboratory committed to providing fully integrated clinical laboratory services which support all phases of both global and regional clinical trials, while retaining a strong emphasis on patient care. When working with Quintiles Laboratories, sponsors get standardized implementation, analytical testing, and database development and transfer. We have a rewarding opportunity for an Associate Lab Project Set-Up Manager. Under general supervision, manage the process of designing and launching single region, less-complex global/regional clinical research studies under general direction; lead activities of the Sponsor/Clinical Research Organization (CRO), and guide the Project Manager (PM) and Set-up Coordinators (SC) in designing and organizing project components. RESPONSIBILITIES * Develop the database design requirements which include configuration (project specific kit contents, laboratory events, requisitions, medical reports), programming for full protocols and protocol amendments, and developing and maintaining client design standards as applicable. * Perform database configuration and programming review and approve verification unit testing while adhering to the database design requirements. * Collaborate with senior colleagues during planning meetings regarding project timelines, and project-related issues focusing on capabilities within Data Management, Logistics, Clinical Trial Materials, Laboratory Testing, and Specimen Management. * Responsible for updates to the project tracking database, action/issues logs, status sheets and timelines during the set up phase. * Communicate and coordinate set-up activities with clients and internal customers to ensure approvals are met, launch is successful, and a seamless transfer of the project to the Project Manager. * Lead in the development of sponsor specific standards and program-specific set-up procedures. * Lead in the identification and resolution of service level issues and where issues affect other projects within and across programs to ensure that any solution is employed universally. * Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate. * As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.). * Participate in external and internal audits as required. * Coordinate and mentor more junior staff; may assist in training new staff on assigned to projects. * Report on team performance against contract, customer expectations, and project baselines to management * Bachelor's degree in science related field and minimum 3 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience * Possess strong interpersonal skills for interaction with senior members within sponsor organizations * Demonstrated ability to meet deadlines * Demonstrated computer proficiency with Microsoft Office and Quintiles LIMS system * Possess an understanding of medical and clinical research terminology * Demonstrated ability to work in a fast-paced, high stress environment * Knowledge of Project Management processes and terminology * Previous knowledge of Quintiles Laboratories processes and computer systems is highly desired * Good organizational and operational skills * Good accuracy and attention to detail skills * Strong written and verbal communication skills including good command of English language * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-03-21 08:05:25United StatesQuintilesGeorgia1204557GAMarietta, GA27284427http://quintiles.jobs/xml/27284427/jobUSAResearch Triangle ParkTitle: (ITLS) Associate Director/Director, IT Validation and Testing, LifeCycle Safety Location: USA-North Carolina-Research Triangle Park Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Associate Director/Director, IT Validation and Testing, Life Cycle Safety position located in our Morrisville (Raleigh/Durham), NC office. The Associate Director, IT (AD, IT) will lead and drive global teams to build and execute effective testing strategies, leading to a successful delivery of products built on Quintiles' Lifecycle Safety Program built on Oracle's Argus safety platform. The AD-IT will lead all aspects of testing through all stages of the system development lifecycle including the creation, deployment and continuous improvement of best practices. RESPONSIBILITIES · Build, grow and incrementally mature Quintiles' testing and quality management capabilities in the Lifecycle Safety program domain and Oracle's Argus product. · Lead the testing and quality management activities across the SDLC. · Provide leadership and technical guidance to Test Managers, Test Leads and their teams. · Responsible for driving efficiency, agility and effectiveness in the end- to-end testing process. · Lead, facilitate and enable teams to develop test strategies and plans that provide adequate consideration to business and technical drivers and associated risks. · Creating and reviewing SOP's, Master Validation Plan, Traceability Matrix, Testing deliverables, and Data Migration Plans. · Drive matrixed execution of the test strategy across functions in Quintiles IT and business units. In particular be effective in working with business analysis, development, operations and product management teams. · Assess and track people availability and utilization to deliver against the agreed test plan and within the applicable schedule and budget constraints. · Ensure adherence to internal testing best practices/standards. · Oversee effort to drive in-process root-cause analysis (RCA) along with corrective & preventive action (CAPA) to ensure that problems are resolved. · Oversee effort to ensure consistent approach to how teams document and communicate results. · Analyze test results and measure/report KPI's against defined quality criteria for products. · Provide oversight across projects to ensure that test deliverables including the use of tools are completed per expected internal guidelines. · Collaborates with peers in other teams to understand dependencies and effectively mitigate risks and issues. · Participate in the product budgeting/estimation process, working to make sure appropriate budget/resource levels are being maintained to deliver work required · Coordinate with the test managers to report staff utilization and the testing status (highlighting business value delivered) to project & program managers on a regular basis. · Support and foster an environment conducive to innovation, high productivity, and high quality. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES: · Minimum of 2 years work experience in the Pharmacovigilance, Drug Safety domain and experience in the implementation of drug safety system projects will be prefered. · Experience working effectively in globally diverse teams and matrixed organizations. · Experience in leading and mentoring global testing teams on large product implementations in the Drug Safety domain. · Excellent Understanding of 21 CFR Part 11 and GxP Regulations. · Understanding of GAMP Guidance and Principles. · Ability to see the big picture of a product (quality and testability) and yet be able to narrow down in specific areas to build a testing approach or resolve issues. · Must have strong knowledge in various life cycle methodologies, including Lean and Agile software development. · Experience of planning and executing testing engagements in the cloud will be useful, but not mandatory. · Customer service orientation · Driven by passion for enabling high performance from teams with the goal of high quality delivery. · Previous program and project management experience will be preferred. · Proven experience in risk management and product delivery experience in a regulated environment. · Proactively initiate, develop and maintain effective working relationships with team members. · Work well with others through cooperation and negotiation · Results oriented · Strong teambuilding skills · Accountability MINIMUM REQUIRED EDUCATION AND EXPERIENCE · MS or an MBA with a specialization in Information Systems or Bachelor's degree highly preferred. ( must have proven technical knowledge and experience accompanied by strong leadership capabilities). · Quality and/or testing certification such Lean Six Sigma, CSQE, PMP certification will be useful but not mandatory. · Solid understanding of Lifecycle Safety/ Drug Safety domain and experience in the delivery of testing engagements on medium to large projects in this domain. Experience in the delivery of Drug Safety projects using Oracle's Argus product will be preferred. · 6-8 years of software development life cycle quality management, quality assurance, of which at least 4 years should have been in a leadership role · Ability to accelerate delivery through the optimization of processes and ongoing introduction of efficiencies. Experience in the implementation of business process re-engineering practices will be helpful. · Experience working within an on-shore/off-shore systems development and support environment. · Ability to build strong relationships in a multi-cultural environment across all levels within IT. · Proven ability to make those around you better, including everyone from individual contributors up to senior management. Proven technical knowledge that will enable the AD-IT to effectively work with the team.2012-03-21 08:05:10United StatesQuintilesNorth Carolina1204524NCResearch Triangle Park, NC27284423http://quintiles.jobs/xml/27284423/jobUSABostonTitle: In-House CRA / Clinical Research Associate - Marlborough, Massachusettes Location: USA-Massachusetts-Boston Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We currently have an opening for an In-House CRA with Medical Device or strong Cardiovascular experience to work in Marlborough, Mass. The In-house monitor executes clinical trials to evaluate safety and effectiveness of medical devices in support of business objectives, including regulatory submissions and publications. Assists in the planning, designing, and executing of studies to ensure the safety and effectiveness of the product. Manage distribution, collection and tracking of regulatory documentation. - Prefer BS/BAor RN - The ideal candidate will have 3-5 years experience in clinical research - Medical Device or Cardiovascular experience a plus -Experience in clinical trials required2012-03-19 08:16:57United StatesQuintilesMassachusetts1204470MABoston, MA27231070http://quintiles.jobs/xml/27231070/jobUSAResearch Triangle ParkTitle: Associate Infrastructure Analyst Location: USA-North Carolina-Research Triangle Park Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our IT Associate Infrastructure Analyst located in our Morrisville (RTP), NC office. ROLE RESPONSIBILITIES · Provide first and second level problem resolution, exercising good judgment within defined procedures and practices to determine appropriate action. · Provide technical support interfacing with IT staff/users to resolve customer needs and support. Provide preventive maintenance on systems as and when required. · Under direct supervision, participate in assigned projects, project teams, task forces as applicable. · Install and modify IT components (e.g. servers, network components, etc.), as appropriate in accordance to corporate policies and procedures. · Work closely with IT staff to support client needs. · Ensure that systems documentation and asset tracking is kept up to date. · Physically install and remove computer equipment in racks · Basic hardware component replacement, such as fans, memory modules, and hard drives. · Maintain a clean and tidy data center that includes proper cable management. · Perform other duties as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Working knowledge in a network environment utlizing PC software. · Working knowledge with LAN environments. · Working knowledge with installation and maintenance of computer systems. · Working knowledge of various computer hardware components. · Excellent, organizational, consultative and communication skills with strong analytical skills. · Ability to establish and maintain effective working relationships with coworkers, managers and clients. · Ability to provide 24x7 support in an on-call rotation. MINIMUM EXPERIENCE · Highly prefer a Bachelor's Degree in Computer Science or related field; · Experience with data center processes and procedures, and a variety of hardware platforms. PHYSICIAL REQUIREMENTS · Ability to lift server equipment weighing up to 70 pounds. · Ability to reach up to six feet to connect and disconnect cables.2012-03-19 08:15:58United StatesQuintilesNorth Carolina1204051NCResearch Triangle Park, NC27230801http://quintiles.jobs/xml/27230801/jobUSAResearch Triangle ParkTitle: Director Clinical Quality Assurance Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. We are looking for a Director, Clinical QA to line manage the team of auditors in North America and Canada, to plan and conduct independent audits, to assess compliance with regulations, guidelines, and operating procedures, to support customer audits and regulatory inspections, to prepare and distribute reports of findings to supervisor, operations staff, management, vendors and customers, as appropriate and to drive global QA initiatives. This individual will also provide consultation in interpretation of regulations, guidelines, policies, and procedures as well as support management in promotion and assessment of compliance to regulations, guidelines and corporate policies. Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions. Responsibilities will include: * Line management of team of auditors in North America and Canada * Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers. * Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. * Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans. * Prepare and review and approve corrective action plans * Present educational programs and provide guidance to operational staff on compliance procedures. * Conduct quality assurance consultancy activities and projects for clients within budget and established timelines, as necessary. * Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements, as applicable. * Host customer audits * Support regulatory inspections * Data entry for QA activities Education: * Bachelor's degree or equivalent combination of education, training and experience * 12 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 5 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience Qualifications: * Knowledge of word-processing, spreadsheet, and database applications. * Extensive knowledge of pharmaceutical research and development processes and regulatory environment. * Knowledge of quality assurance processes and procedures. * Working knowledge of GXP regulations, 21 CFR Part 11, and vendor auditing. * Strong interpersonal skills and management experience. * Excellent problem solving, risk analysis and negotiation skills. * Strong training capabilities. * Effective organization, communication, and team orientation skills. * Strong time management skills. * Ability to initiate assigned tasks and to work independently. * Ability to manage multiple projects. * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-03-16 08:13:56United StatesQuintilesNorth Carolina1204294NCResearch Triangle Park, NC27190206http://quintiles.jobs/xml/27190206/jobUSAMinneapolisTitle: Clinical Research Associate/ Sr CRA - Oncology/ Minnesota Location: USA-Minnesota-Minneapolis Other Locations: USA-Ohio Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Cleveland, OH! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at an entry level CRA, CRA or Sr. CRA level depending on experience and may include customer-managed clients. Should have oncology experience. - Bachelors Degree -2 years of CRA monitoring experience -Must live in the Minneapolis, Minnasotaarea -Must have Oncology experience -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-03-14 09:04:40United StatesQuintilesMinnesota1204231MNMinneapolis, MN27129599http://quintiles.jobs/xml/27129599/jobUSAAustinTitle: Manager, Clinical Operations Location: USA-Texas-Austin Other Locations: USA-Arkansas, USA-Louisiana, USA-Arizona, USA-Oklahoma, USA-Texas-Houston, USA-Colorado, USA-Utah, USA-New Mexico, USA-Texas-San Antonio, USA-Texas-Dallas Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic Manager, Clinical Operations to join our team for the South region! This position is home-based. PURPOSE Manage the human, material, system and fiscal resources to provide clinical monitoring services within a designated office, country or region. Ensure that clinical staff (CTAs, Sr CTAs, CRAs, Sr CRAs, Principal CRAs and/or CTLs) gain the necessary skills to perform their respective job responsibilities. RESPONSIBILITIES • Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. • Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. • Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable. • Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training. • Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. • Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff. • Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management. • May act as a CRA or CTL for a defined project or to assist with milestone achievement. • May participate in clinical operations quality or process initiatives. KNOWLEDGE, SKILLS AND ABILITIES • Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. • Strong leadership skills. • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. • Strong written and verbal communication skills including good command of English. • Excellent organizational and problem solving skills. • Effective time management skills and ability to manage competing priorities. • Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree in a health care or other scientific discipline or educational equivalent;6 yrs of experience working on clinical trials with 3 years experience in a leadership capacity; or equivalent combination of education, training and experience.2012-03-12 08:19:51United StatesQuintilesTexas1203954TXAustin, TX27066525http://quintiles.jobs/xml/27066525/jobUSACambridgeTitle: Business Development Director Location: USA-Massachusetts-Cambridge Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. Purpose : This role will lead in the implementation of sales strategies and customer plans to achieve global sales objectives for Outcome's US sales team. It will position the Company to win a significant proportion of outsourced projects from assigned customer(s). Primary Responsibilities: § Generates sales from assigned customers to achieve individual and team targets. § Increases market penetration that is measured by an increase in new contact meetings, RFP activity, proactive proposal submissions and win rate. § Creates new sales opportunities within assigned accounts by researching, analyzing, and monitoring news articles, PR announcements and trends in the biopharmaceutical and medical device industries to generate potential contacts and leads. § Provides direction for marketing activities to generate leads and build brand awareness. § Aggressively pursues awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards for assigned customers. § Communicates specific customer needs on specific opportunities by completion of an effective briefing document. Drives specifics to develop 'fit for purpose' solutions working in conjunction with Proposals and Operations. § Serves as primary facilitator and owner in customer presentations/meetings and the development of the appropriate teams for such meetings including bid presentations, contract negotiations, etc. § Establishes professional working relationship with support team and other service groups. Coordinates customer communication. § Openly communicates with internal Project Managers to assess the overall level of customer satisfaction and progress of projects. § Ensures sales compliance with routine use of CRM (Salesforce). § Represents the Company at trade shows and professional conferences as necessary. § Maintains an in-depth knowledge of Outcome services. Provides timely completion of administrative responsibilities including Expense Management. Requirements: § Bachelor's degree in Business Management or scientific discipline specific to pharmaceutical development. § Minimum 5 years direct sales experience within a Contract Research Organization (CRO) or Technology Services organization calling into the Healthcare industry. § Biopharmaceutical marketplace or equivalent combination of education and experience. § Experience selling EDC or post-approval technology solutions preferable. § Demonstrate computer literacy. § Possess outstanding written, verbal, negotiating, organizational, and interpersonal skills. § Possess strong networking skills § Must have the ability to make decisions when facing ambiguity2012-03-12 08:18:47United StatesQuintilesMassachusetts1204112MACambridge, MA27066300http://quintiles.jobs/xml/27066300/jobUSACambridgeTitle: Head of Data and Provider Businesses Location: USA-Massachusetts-Cambridge Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE This role is accountable for the overall P&L of the emerging segments of Outcome's Data Analytics and Provider businesses. The incumbent will grow market share by developing and implementing business strategies that will enable health data analytics services to meet complex customer requirements. This role is also responsible for growing the company's current provider business and will oversee business development activities and interface with service delivery groups to ensure that customer commitments are met. RESPONSIBILITIES * Drive achievement of P&L. * Develop and enhance long-term relationships with senior level executives and key decision makers in target provider and data organizations. * Create and share deep customer knowledge and market knowledge. * Lead business development efforts by anticipating and identifying key customer solution gaps and opportunities, lead global strategic customer initiatives and prioritization of customer opportunities. * Identify obtainable data assets in the market and establish business relationships to enable the use of data assets to deliver complex, customized solutions for customers. * Makes decisions on pricing, investments, and risks within approved limits. * Oversee business development, project performance, and customer satisfaction. * Set and manage expectations with customers and stakeholders. * Ensure compliance with regional data privacy regulations. * Provides management and strategic guidance to business development professionals. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Entrepreneurial experience building a business and proven ability to manage a significant P&L. * Ability to define a clear strategy and execute a business plan for an emerging market. * Extensive knowledge of health data analytics. * Familiarity with hospital and practice quality measurements and reporting * Leadership experience as an effective driver of business development and negotiation activities from proposal through solution definition. * Proven experience motivating and leading large, cross- functional business development and service delivery teams. * Strong verbal, written, presentation, facilitation, and communication skills. * Proven record of building strategic partner relationships as well as managing growing a robust portfolio of profitable customer projects. * Ability to lead, grow and mentor a team. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in a scientific or business disciple. A minimum of 15 years of increased responsibility in medical data management, biopharmaceutical, or related service companies. Must have large account management experience, 8 years of management experience; or equivalent combination of education, training and experience.2012-03-12 08:18:43United StatesQuintilesMassachusetts1204109MACambridge, MA27066282http://quintiles.jobs/xml/27066282/jobUSAMinneapolisTitle: Inhouse CRA - Arden Hills, Minnesota Location: USA-Minnesota-Minneapolis Other Locations: Quintiles is the only fully integrated Biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. We are continuously in search of talent that can help advance our mission. Currently we are seeking an iCRA The iCRA duties will include managing the sites of various principal investigators remotely through interaction with assigned PI representatives and assisting with the development of Clinical management plans, Site management plans, and other related documents/agreements. You will oversee the collection of data from patient charts, medical records, interviews, questionnaires and AE/SAE reporting and ensure the accurate evaluation and quality assurance of collected data, and preparation of appropriate documentation. You will ensure compliance with protocol guidelines and requirements of regulatory agencies and evaluate and interpret collected clinical data in conjunction with the PI. You will also oversee the site and patient reimbursement process and serve as consultant on protocol and clinical research form (CRF) development as well as other study documents. *Must be able to commute to Arden Hills, Minnesota Bachelor's degree in Health, Biological Sciences or related field or two years of related experience; or equivalent combination of education, training and experience. * Demonstrated knowledge of GCP guidelines * Effective negotiation and problem-solving skills * Demonstrated ability to manage multiple tasks concurrently * Possess strong computer skills with experience utilizing word processing, spreadsheet, and database applications * Possess strong interpersonal and organizational skills, as well as strong verbal and written communication skills * Possess strong attention to detail2012-03-12 08:18:17United StatesQuintilesMinnesota1204178MNMinneapolis, MN27066196http://quintiles.jobs/xml/27066196/jobUSAResearch Triangle ParkTitle: Director/Sr Director, Clinical Solutions & Support Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE The Clinical Solutions Director/Sr. Director is an experienced clinical research professional responsible for implementing and embedding innovative solutions to accomplish mid to long term objectives in line with global clinical operations strategies for the Clinical Organization This position is office-based, but consideration would be made to home based if within the North Carolina vicinity so that weekly presence in Quintiles RTP office can be achieved Will work with Global Clinical Solutions to plan, organize and implement agreed global strategies. RESPONSIBILITIES · Responsible for proposing and developing concepts, systems and processes that will promote consistent and high quality standards and operational delivery · Responsible for tracking and monitoring delivery of implemented solutions and feeding back into the continuous improvement cycle. May be accountable for tracking the impact via metrics, making further adjustments as needed to achieve required performance levels · Works with key stakeholders such as Global learning and development (L&D, Therapeutic Delivery Solutions (TDS), Integrated Process and Technology (IPT), Integrated Site Services (ISS) and Data Management (DM) in the planning and implementation of appropriate solutions encompassing any amendments required to meet local cultural or legal requirements · Collaborate with the CRA Advisory Board to be the voice of Clinical Operations for new systems and processes so that they can be fit for purpose when introduced. · Work with Clinical Operations and Quality Management to drives consistency of clinical standards through audit report analysis and quality manager feedback. · Partner with Corporate Communications to ensure consistent and informative messages are provided to the Clinical Community · May be required to works with sales/corporate development to support the winning of and retention of new business · May from time to time join specific project teams to improve customer satisfaction where less than optimum score are achieved · Acts as a conduit between Clinical Operations and all other groups as required. Exchanges information, creates and oversees the delivery of execution plans as appropriate. · Organizes Regional or Global meetings ensuring that agenda content and purpose is in line with the strategic direction/imperatives. Captures actions and tracks to completion. REQUIREMENTS Bachelor's degree in a health care or other scientific discipline or educational equivalent;12 yrs of experience working on clinical trials with 9 years experience in a leadership capacity; or equivalent combination of education, training and experience REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • In depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines • Knowledge of clinical research financial parameters and project financial tracking and accounting methods • Strong leadership skills • Effective presentation skills • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint • Strong written and verbal communication skills including good command of English · Strong technical aptitude for systems and databases • Excellent organizational and problem solving skills • Effective time management skills and ability to manage competing priorities • Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-03-08 08:35:59United StatesQuintilesNorth Carolina1203882NCResearch Triangle Park, NC27001061http://quintiles.jobs/xml/27001061/jobUSASan DiegoTitle: Associate Medical Director/Medical Director/Senior Medical Director - Neurology Location: USA-California-San Diego Other Locations: USA-Georgia-Atlanta, USA-Maryland-Rockville, USA-New Jersey-Parsippany, USA-North Carolina-Research Triangle Park, USA-Kansas-Overland Park The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiasticAssociate Director/Medical Director/Senior Medical Director within Neurologyto join our team! The Associate Director/Medical Director will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested. Incumbent will participate in all aspects of Medical and Scientific Services' involvement on assigned trials. Assists in the implementation of department mission, goals and objectives, oversight of operations, development of policies and procedures and standards for the department. RESPONSIBILITIES * Serves as Regional Medical Advisor and/or Global Medical Advisor on assigned projects. * Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. * Performs review and clarification of trial-related Adverse Events (AEs). * Performs medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives. * Provides medical support for the Analysis Of Similar Events (AOSE). * Performs medical review of Adverse Event coding. * Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs). * Performs medical review of the Clinical Study Report (CSR) and patient narratives. * Available 24 hours per day, 7 days per week, to respond to urgent protocol-related issues at the investigative sites. * Attends and presents at the Investigator Meeting(s). * Provides therapeutic area/indication training for the project clinical team. * Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested. * Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects. * Provides support to the proposal development team which may include, but is not limited to, reviewing the protocol for feasibility, giving guidance as to anticipated enrollment, and general advice as to the various risks associated with running a particular study. * Participates in the development of Medical & Scientific Services portion of client proposals including the budgeting * process. * Serves as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development activities for Medical & Scientific Services. * Budget responsibility for large global multi-million dollar programs; responsible for all safety issues on these programs. * Provides expert consultation to NovaQuest, the Partnering Group of Quintiles Transnational, and supports the due diligence research of select compounds and/or companies as requested. * Serves as Regional Medical Director and/or Global Therapeutic Head for larger teams and/or regions. * Participates in management level meetings within Medical & Scientific Services. * Supervises Medical and Scientific Services Staff with assigned direct reports and provides mentoring as required. * Ensures that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented by assigned staff. * Recommends course of action on management/human resources matters, including salary administration, transfers, * hiring, terminations, professional development, performance appraisals, and employee counseling. * Identifies ongoing training and development needs of assigned staff. * Evaluates assigned staff workload and creates volume projections in order to ensure appropriate balance of project * assignments for direct reports. * Maintains awareness of industry developments and participates in professional meetings, and may author related * publications. * Performs special projects as requested by management. A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the works is required, plus a minimum of 5 years experience in clinical medicine, in addition to 1-2 years clinical development experience in the Pharma, CRO, or Biotech industry. Specialty Board certification desirable; or equivalent combination of education, training and experience. * Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to regulatory affairs * Ability to establish and meet priorities, deadlines, strategic department goals and objectives. * Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility. * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-03-08 08:35:54United StatesQuintilesCalifornia1203959CASan Diego, CA27001055http://quintiles.jobs/xml/27001055/jobUSAInternal Medicine New BernTitle: Pharmaceutical Sales Representative - Internal Medicine New Bern, NC 6517 Location: USA-North Carolina Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Internal Medicine Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making o v er 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Internal Medicine Pharmaceutical Sales Representative The primary objective of the sales representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor degree required · Minimum 3 years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required · Excellent written and oral communication skills required · Ability to travel as necessary (some overnights and weekends) is required · Prior experience in pain management, cardiovascular and/or metabolic/diabetes therapeutic area, gastrointestinal disorders and therapies or other internal medicine areas preferred · Documented sales results · Participation in management development program preferred · Residence within the current geography or willingness to relocate to the current geography is required Competencies · Performance and results driven · Customer expertise · Professional credibility · Business Insight · Collaboration · Thrives in Ambiguity2012-03-06 08:08:21United StatesQuintilesNorth Carolina1203873NCInternal Medicine New Bern, NC26945534http://quintiles.jobs/xml/26945534/jobUSANoneTitle: Regional Director — West - Neurology 6427 Location: USA-California Other Locations: USA-Kansas, USA-Colorado, USA-Utah, USA-Washington, USA-Arizona, USA-Texas As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking forRegional Sales Directorto join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. The Regional Sales Director will lead a team of Regional Account Managers . They will work closely with the National Sales Director, internal Sales Operations and Marketing and a Reimbursement team to execute the sales and mar strategy for our client. They will be an expert in both the Injectable and Neurology specialty arena and will be expected to demonstrate a deep understanding of the customer business model and be able to react appropriately to customer and client needs. They will also be responsible for delivering on all contractual obligations as agreed to with the client. This position will be primarily West of Mississippi. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOEPfizer Requirements · 4 year degree required · 3 years experience and a proven track record as a District or Regional Sales Manager in the pharmaceutical/biotechnology market · 3 years of buy and bill experience with injectable medications required · Proven successful track record in Neurology Sales and managed markets · Proven experience to work with Sales Operations and Marketing · Prior experience as a Regional Sales Director preferable · Demonstrated ability to recruit, hire and coach Direct Reports to success · Proven ability to display district/region leadership, performance management & career planning · Strong work ethic and customer focus orientation Competencies · Demonstrated analytical skills · Demonstrated Business Acumen · Demonstrated ability for Strategic and Tactical Planning · Demonstrated success in persuasion, influence and negotiation skills · Demonstrated leadership ability · Demonstrated ability to apply technical/scientific knowledge · Flexibility to learn new products over time · Knowledge of and experience with the selling process · Initiative & execution-oriented · Teamwork2012-03-06 08:08:19United StatesQuintilesCalifornia1203881CACalifornia, USA26945532http://quintiles.jobs/xml/26945532/jobUSAHawthorneTitle: Principal Consultant, Pricing and Market Access Location: USA-New York-Hawthorne Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Specific responsibilities to the role may include: * Assist in managing client engagements * Prepare client presentations * Participate in the design project research, analysis, and reporting techniques * Team with Engagement Managers regarding the development of project research materials including analysis plans, surveys, discussion guides, and other data collection instruments * Analysis and interpretation of data * Production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, etc. * Contribute to proposal writing Sample Engagements Include: * Market assessment, evaluation and forecasting * Market research * Pricing and reimbursement strategy development and support * Product positioning and development * Scenario planning * 5 years consulting experience * 2 years experience and abilities in the following areas: US and Ex-US pricing and market access environment, HTAs, payer/managed markets strategy, contracting strategy, value proposition development, market research, commercialization of drugs * Play a key role in development of capabilities and offerings in the practice and participate in business development of those related activities * Consult with clients on strategic issues, expanded project scopes and future business opportunities * Serve as primary client contact on projects (e.g. project manager role) * Superior excel/modeling, analytical, communication, and presentation skills (sample will be required) * Good presentation skills (deliver expert presentation on topics of interest to potential clients) * Bachelor's degree required * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * Ability to travel to the client site as necessary Nice-to-Haves: * Understands value-based pricing & health economics * Present research findings to industry clients and at professional conferences. Publish research in-peer reviewed literature. * Maintain proficiency of skills and knowledge and remain current with industry trends based on current literature, application of new technology, attendance at professional meetings, etc.2012-03-01 08:50:06United StatesQuintilesNew York1203675NYHawthorne, NY26857272http://quintiles.jobs/xml/26857272/jobUSANoneTitle: Instructional Designer Location: USA-North Carolina Other Locations: USA-Vermont, USA-Pennsylvania, USA-Rhode Island, USA-Maine, USA-Maryland, USA-Ohio, USA-Delaware, USA-New Jersey, USA-Florida, USA-Connecticut, USA-Kentucky, USA-New Hampshire, USA-Massachusetts, USA-Virginia, USA-New York, USA-Georgia Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. With an established global network of 23,000 engaged professionals in over 50 countries, we collaborate with an unwavering ethical commitment to patients and safety. By navigating risk and seizing opportunities, Quintiles thrives on the realities of constant change to make people healthier through our alliances. Our market differentiation is revealed in our successes: Quintiles has helped our allies develop or bring-to-market all of the world's top 30 best selling drugs, and 9 of the top 10 biologics. We invite you to join us as we continue on our quest to shape the New Health Landscape. We are currently seeking three Managers/ Associate Directors of Instructional Design.THIS ROLE CAN BE HOME BASED ANYWHERE IN THE UNITED STATES - EASTERN STANDARD TIME ZONE!!! Job Requirements * Using Human Performance Improvement methodology, conduct business analyses, performance analyses, and needs analysis in partnership with business leaders to identify role based performance expectations and performance/proficiency gaps. * Partner with business unit leaders as a performance consultant to align training and performance improvement efforts with organizational and functional strategic goals. * Collaborate with the Organizational Development, Training Solutions, Performance Partner, and other relevant functions within L&D to leverage existing resources and expertise to achieve results-focused solutions. * Using the ADDIE (Training Cycle), framework, execute the in-take, a nalysis, d esign, and d evelopment of instructional programs for increasing workforceperformanceand proficiency. * Use project management methodology to implement instructional programs that bridge the gap between current and future performance needed to implement and maintain new/changing business processes and technologies. * Design and develop blended learning solutions that achieve the knowledge, skills, and behavioral changes needed to meet business goals. * Partner with Training Effectiveness to develop evaluation plans that generate the data and information needed to assess the adoption, application, and impact of newly learned knowledge and skills on the job. * In partnership with the Training Advisory Board members, own and manage the training plans ( assigned to your TAB) to implement and maintain a holistic curriculum that addresses workforce performance and development needs for that function. * Use instructional design tools , such as Articulate and Captivate to develop e-learning solutions as part of a blended learning program. * Ensure that Good Clinical Practices (GCP), 21 CFR Part 11 Electronic Record/Signature, and LMS specifications and compliance requirements are adhered to when managing, developing, documenting, and storing instructional programs and events to ensure compliance with FDA, EMEA, ICH and rest of world regulations. * In the capacity of a project manager, evaluate and manage vendors for outsourcing training development and delivery. * Identify and implement new technologies to simplify the development and delivery of effective training programs, such as social learning media. * Prepare and defend budgetary recommendations, requests, reports, proposals and/or projections. Education Requirements * Masters Degree in Learning & Development, Instructional Design, Organizational Development or other similar degree preferred, or 7 years of experience in one or more of these areas Technical Requirements * Technical Skills Required: Proficient in Learning Management Systems, Intermediate to Expert proficiency in Articulate (Presenter, Engage, and Quizmaker), Captivate, or other similar e-learning tools Skills Required * Project Management * Performance Consulting * Needs Analysis * Instructional Design * Vendor Management * Blended Learning Design * Curricula Development and Management2012-03-01 08:49:43United StatesQuintilesNone1203660NoneVirtual, USA26857265http://quintiles.jobs/xml/26857265/jobUSASalt Lake CityTitle: Entry Level CRA / CRA / Sr. CRA - Salt Lake City Location: USA-Utah-Salt Lake City Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team in Salt Lake City, UT! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. - BS/BA required. - 1 year of on-site monitoring experience or combination of 3 years clinical research coordinator experience (mandatory) or 2 years of on-site monitoring experience. - Oncology experience preferred.- Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-03-01 08:49:42United StatesQuintilesUtah1203648UTSalt Lake City, UT26857264http://quintiles.jobs/xml/26857264/jobUSARockvilleTitle: Biostatistician 1 Location: USA-Maryland-Rockville Other Locations: The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking a enthusiastic Biostatistician 1. The Biostatistician 1 will participate in one or more project teams. Prepare analysis plans and write detailed specifications for analysis files, consistency checks, and tables/figures/listings. Write statistical section of study reports and provide general statistical analysis support for project teams. RESPONSIBILITIES • Develop analysis plans, table shells, programming and table specifications; produce tables, listings and figures; perform data review and statistical analysis. • Assist with protocol development, sample size calculation, and protocol and case report form (CRF) review. • Advise data management staff on database design, validation checks and critical data. • Assist in writing statistical sections of integrated reports. • Assist project lead in fulfilling project responsibilities. • Under supervision, manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. • Provide training and guidance to lower level and new staff.• Masters degree or educational equivalent in biostatistics or related field. • Strong aptitude for and strong working knowledge of SAS computing packages • Familiarity with basic statistical methods that apply to Phase I-IV clinical trials • Ability to effectively manage multiple tasks and projects and accept direction of lead team members • Excellent organization and communication skills2012-02-29 07:47:06United StatesQuintilesMaryland1203597MDRockville, MD26831760http://quintiles.jobs/xml/26831760/jobUSACambridgeTitle: Director, Site & Patient Services - Americas - Outcome Sciences Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. PURPOSE Direct clinical monitoring operations for a designated Quintiles regional office or group to ensure projects are appropriately resourced and employees are trained and developed to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for designated region and assures operational alignment with senior management priorities. Lead strategic initiatives work with other functional management to develop implementation plans. Supervise Clinical Team Leads (CTLs), Clinical Study Managers (CSMs) and/or less experienced line managers as directed by senior management. RESPONSIBILITIES • Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters. • Direct the hiring and selection process for a group of clinical staff by conducting candidate review through participation in the interviewing process. Establish methods to develop and evaluate office/region based onboarding processes. Develop standard processes to ensure that staff have the proper materials, systems access and training to complete job responsibilities. Oversee the execution of the training plan, SOP review and mentored training experiences for a region/office/country. • Provide a leadership role in country/region clinical resourcing process through continual evaluation of existing and future resource alternatives, pro-active planning and collaboration with study team leadership and operational peers. • Evaluate the quality of the clinical work product for a variety of job roles and/or a specialized job function. Evaluate regional workload, quality and budget metrics through regular review and reporting of findings. Collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinical projects. • Act as a coach and mentor for managers, CSMs and Clinical Study Directors (CSDs) as they develop in their role. Works collaboratively with project leadership including the PM, client representatives and other functional leadership to manage project related challenges and to achieve exemplary customer service. • Analyze and reviews budgets for clinical studies within region. Pro-actively plan for appropriate clinical operations budget consumption and guides line managers and CTLs in managing variances and in developing corrective fiscal action plans. • Conduct Clinical Project Review and participates in Project Management Review according to regional guidelines and interfaces with appropriate functional leadership to achieve positive outcomes. • Participate and may lead corporate or departmental quality or process improvement initiatives. • May act as a client liaison. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • In depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines • Knowledge of clinical research financial parameters and project financial tracking and accounting methods • Strong leadership skills • Effective presentation skills • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint • Strong written and verbal communication skills including good command of English • Excellent organizational and problem solving skills • Effective time management skills and ability to manage competing priorities • Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE • Bachelor's degree in a health care or other scientific discipline or educational equivalent;10 yrs of experience working on clinical trials with 7 years experience in a leadership capacity; or equivalent combination of education, training and experience2012-02-29 07:46:54United StatesQuintilesMassachusetts1203441MACambridge, MA26831754http://quintiles.jobs/xml/26831754/jobUSASeattleTitle: Clinical Research Associate / CRA / Sr CRA / Western US - Cardio/Device ~ Location: USA-Washington-Seattle Other Locations: USA-California-San Diego, USA-California-Los Angeles, USA-Nevada-Las Vegas Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Prefer BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-29 07:46:35United StatesQuintilesWashington1203567WASeattle, WA26831750http://quintiles.jobs/xml/26831750/jobUSASan FranciscoTitle: Clinical Educator, Oncology/Infusion Specialty - San Francisco/Seattle - 4425 Location: USA-California-San Francisco Other Locations: USA-California-San Jose, USA-California-Fresno, USA-Oregon-Portland, USA-Washington-Seattle, USA-California-Sacramento As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for ClinicalEducatorswith experience in oncology and/or hematology and/or infusion to join our team of over 10,000 global field representatives in several regions for our pharmaceutical and biotech clients. In this role you will be supporting a major pharmaceutical company by educating peers on a product utilized in the hematology/oncology disease state. Clinical Educator - Oncology/Infusion Specialty The Clinical Educator - Oncology/Infusion Specialty provides education to their peers in transfusion centers to gain a better understanding of patients at risk for chronic iron overload and implementation of processes to identify patients at risk. Education is also presented to help staff have a better understanding of disease state treatments and proper dosing and administration of these treatments. This education is provided through formal presentation, round table discussion and individual interactions. This is a field based employee. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · RN with a 4 year Bachelor's degree required, masters degree preferred · Oncology and/or Hematology and/or Infusion Nurse specialist with health educator experience required · Oncology Certified Nurse preferred · Current license in good standing · Minimum of 3-5 years of Hematology/Oncology clinical experience · Transfusion experience required; blood bank experience may be considered with clinical background · Excellent teaching skills · Strong interpersonal skills, with demonstrated effectiveness working independently and on cross-functional teams · Excellent organizational skills · Experience in delivering service solutions desirable · Ability to manage multiple tasks · Willingness to travel · Excellent written and oral skills · Excellent presentation skills · Enthusiastic, good attitude, and ability to motivate others2012-02-29 07:46:34United StatesQuintilesCalifornia1203546CASan Francisco, CA26831749http://quintiles.jobs/xml/26831749/jobUSAResearch Triangle ParkTitle: Strategic Biostatistics Director (Late Phase) Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Maryland-Rockville When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialization services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialize every single one. We have an opportunity for a Senior Strategic Biostatistics Director to provide strategic statistical and epidemiological/outcomes research input to high-priority Late Phase sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of product commercial success through appropriate management of risk and value demonstration. Represent Quintiles externally with healthcare stakeholders (FDA, EMEA, Payers, Insurers etc) and actively pursue thought leadership opportunities. RESPONSIBILITIES * Provide strategic statistical and epidemiological/outcomes research input to Late Phase sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of product commercial success through appropriate management of risk and value demonstration. * Provide strategic biostatistical and epidemiological/outcomes research consultancy to customers on a billable basis * Maintain knowledge and awareness of developments in biostatistics, epidemiology and outcomes research. Carry out new developments in areas of statistical design or analysis that can be used to give Quintiles a greater edge over competing CROs. * Market Quintiles' statistical and epidemiologic/outcomes research expertise, may include:(i) publishing papers that demonstrate expertise in key areas (such as risk management, health economic assessment); (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business; and (iv) contribute to publicizing internally to key groups. * Actively network in the industry to establish relationships and to identify potential opportunities. * Deliver/oversee billable services to customers aligned with domain expertise May oversee and participate in the provision of training to internal Quintiles staff REQUIRED KNOWLEDGE, SKILLS AND ABILITIES • Extensive and moderately in-depth knowledge of many of those complex statistical analysis methods that apply to Phase IIIB/IV clinical trials and prospective observational research, which can be used to cut time, cut costs, and/or increase chance of success • Good overview knowledge of many of the new and cutting-edge design and analytical approaches that can beneficially be applied to Phase IIIB/IV clinical trials and observational studies • Ability to develop new methods to cut costs, decrease time, or increase success for marketed drugs • Moderately high level of knowledge of current guidelines with respect to pragmatic trial and observational study designs, endpoints, and acceptable analyses for multiple therapeutic areas • Good understanding of peri- and post-approval research needs • Knowledge of SAS • Excellent written and oral communication skills • Strong negotiating skills • Ability to operate simultaneously across numerous projects • Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · MSc or PhD in Epidemiology or closely-related discipline · CRO/consulting and pharma experience · Observational research/registry and Patient Reported Outcomes (PRO) experience · Active externally with professional bodies/academic groups At Quintiles we value individuality, fresh ideas, and the contribution that our employees make to our success. In return we offer career opportunities providing flexibility and growth across the organization, covering multiple locations to suit your lifestyle requirements at this time, a competitive salary and a fantastic benefits package. If you want to make a difference in global healthcare, Quintiles is the place for you. It's work worth doing.2012-02-29 07:45:50United StatesQuintilesNorth Carolina1203600NCResearch Triangle Park, NC26831703http://quintiles.jobs/xml/26831703/jobUSARaleighTitle: *Senior Biostatistician - Raleigh, NC Location: USA-North Carolina-Raleigh Other Locations: Quintiles is seeking an enthusiastic Senior Biostatistician to join our U.S. Biostatistics Operations team. Position will be office based in Raleigh, NC The Senior Biostatistician will develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. RESPONSIBILITIES • Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis. • Perform protocol development, sample size calculation, protocol and CRF review. • Advise data management staff on database design, validation checks and critical data. • Write statistical sections of integrated reports. • Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data). • Fulfill the Lead role for single complex studies or groups of studies. • Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. • Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings. • Manage customer relationships and provide training and guidance to lower level and new staff. • PhD or educational equivalent in biostatistics or related field and 1 year relevant experience; Master's degree or educational equivalent in biostatistics or related field and 3 years relevant experience • Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials • Strong working knowledge of SAS computing package • Familiarity with other statistical computing packages such as S , SUDAAN, StatXact • Pharmaceutical, drug development, biotech or CRO industry experience • Excellent written and oral communication skills including grammatical/technical writing skills • Excellent attention and accuracy with details • Strong individual initiative, organization skills and multi-tasking ability. • Ability to lead and co-ordinate small teams2012-02-21 12:24:39United StatesQuintilesNorth Carolina1202480NCRaleigh, NC26643543http://quintiles.jobs/xml/26643543/jobUSADurhamTitle: Semio Design Consultant Location: USA-North Carolina-Durham Other Locations: USA-Indiana-Indianapolis PURPOSE The Quintiles Planning and Design Unit is a dedicated cross-functional team pursuing the development and delivery of select drug development planning and design services through the merging of extensive drug development expertise with transformative technologies, methods, and work models. Underpinning this vision is an integrated custom Semio environment that leverages digitization, automation, reuse, and decision-support. The Design Consultant provides day-to-day direct consulting to achieve client expectations through the development, implementation, and delivery of Semio planning and design consulting services. Leads Semio client engagements through the planning and design lifecycle of clinical programs. Using novel tools and information, facilitates focused design sessions to support clients in design and planning decisions and develops and delivers Semio reports, structured outputs (such as final study scientific and operational specs), materials for governance bodies, etc. partners across the Quintiles Enterprise and the Drug Development Sponsor to bring the right people and information to the design sessions. Provides the "voice of the customer" in the definition and development of service requirements. Reports to the Planning and Design Unit Semio Delivery Team Lead. RESPONSIBILITIES · Own and drive the Planning and Design Unit Semio client planning and design engagements, including project/program management of the Semio methodology o Identify client needs (design problem), define design remit , establish client contract/charter, interview clients, populate Semio tool suite, analyze stakeholders, steward client engagement, coordinate and facilitate design sessions, bring together information and people necessary to design the clinical plan and trials, identify outstanding issues, identify opportunities to provide information/data to inform decisions, drive the decision making process, capture client decisions and assumptions, develop and deliver outputs, and ensure objectives are met within agreed project timelines. · Define and refine Planning and Design Unit Semio services and capabilities o Lead the development of and own the design session process, including all required information and process needs. Collaborate with Semio Service Development peers to drive alignment of method of work definition and to understand and assist in development of the Semio Services. Define business requirements to the Semio Service Development team as they build technical components of Semio services. · Co-facilitate client engagements and directly contribute to the achievement of project deliverables including ad-hoc analyses, Semio reports, structured outputs (such as final study scientific and operational specs), materials for governance bodies, technical reports, presentations, and service dossiers. Manage project team in accordance with performance targets (e.g. staff utilization). Adjust resources, deliverables and client expectations accordingly. · Participate in Business Development, Marketing and Sales activities. Deliver business development/program presentation to prospective clients. · Participate in the continuous improvement of departmental processes and procedures. · Serve as team lead on engagements · Provide strategic consultation regarding client issues and make recommendation on appropriate solutions. · Serve as primary client contact on Semio planning and design projects · Consult with clients on strategic issues, expanded project scopes and future business opportunities. · Evaluate current assignments and work to develop global or expanded opportunities. · Provide technical expertise and consulting input into proposals. · Deliver expert presentation on topics of interest to potential clients. · Maintain proficiency of skills and knowledge and remain current with industry trends based on current literature REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Excellent interpersonal and collaborative skills for relationship building · Strong demonstrated technical understanding - scientific, operational and commercial · Excellent insight and proactive problem solving through innovative and pragmatic solutions · Demonstrated high tolerance for technological challenges · Proven experience of managing raw data, through to aggregated information, to drive knowledgeable outcomes · Deep demonstrated comprehension of emerging clinical development information needs and related technology and processes · Demonstrated entrepreneurial spirit and role/task versatility · Excellent communication (verbal and written) and facilitation skills · Experience and ease in dealing with ambiguity and novel situations · Improvisational skills, adaptable · Capacity and disposition for collaboration across disciplines · Ability to connect ideas, people, and information in novel ways to address problems and move projects forward · Self-starter, , highly motivated, quick learner · Strong knowledge of decision analysis techniques, database analysis methods, statistical analysis and reporting, and technical writing. · Strong computer skills, including Statistical programs (e.g. SAS), decision analytical modeling, database mining and Microsoft Office applications · Good influencing and negotiation skills · Excellent customer service skills · Ability to lead, guide and motivate others to achieve desired results · Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree or educational equivalent in medical, science, or technology related fieldor equivalent experience · 12 years clinical development experience - with a focus towards a deep understanding of the overall clinical development process, including · 8 years experience in clinical planning, clinical trial operations, clinical trial design · 5 years experience in Consultative/Facilitation experience to manage to outcomes · Project Management experience and/or education PHYSICAL REQUIREMENTS · Extensive use of keyboard requiring repetitive motion of fingers. · Extensive use of telephone and face-to-face communication requiring accurate perception of speech. · Regular sitting for extended periods of time. · 50% Travel Indianapolis, Indiana or Raleigh/Durham, North Carolina preferred.2012-02-21 12:24:29United StatesQuintilesNorth Carolina1202076NCDurham, NC26643535http://quintiles.jobs/xml/26643535/jobUSADurhamTitle: Head of Data Factory, Infosario Location: USA-North Carolina-Durham Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Head of Data Factory position located in our Morrisville, NC office. Quintiles' Infosario is a platform for Biopharma offering a variety of solutions, including Reporting and Analytics, Data Driven Processes, Data Archival / Data Warehousing (Data Services) and Customized Service Systems. We are seeking an executive level within the Infosario Product Delivery organization to lead the Data Services group. The incumbent will serve as a program manager and functional head ; he or she will have experience in leading and managing multiple products and a diverse group of people globally . The selected candidate must also be experienced in a variety of software development practices for customized storage and data integration platforms. Purpose: The Head of Data Factory will develop and drive strategy for the Data Services enterprise within Infosario, working closely with leadership, staff, vendors and partners globally to develop and deliver a leading product/service within the pharmaceutical industry. As an integral part of Infosario, the Program Manager and Head of Data Services will lead a product team consisting of account managers, project managers, engineers, architects, business analysts, validation experts, support specialists, other technical personnel. Through regular interface with internal and external stakeholders and customers, the incumbent will ensure success of the program and drive the group towards profitability. Key responsibilities overseeing at a high level the following areas of the product team: Managerial / Leadership: - Oversee strategy for the creation and execution of customized data oriented services - Successfully lead a team to achieve given objectives - Collaborate with business leaders to identify business opportunities and the potential to streamline processes / efficiencies. - Define and implement process improvements by establishing clear ownership and accountability - Oversee all data development and business intelligence activities - Build and maintain effective relationships with program stakeholders at all levels across the organization. - Facilitate open communications with all program stakeholders, including staff, managers, leaders, vendors and partners, managing expectations - Ensure that reports provided by team are timely, accurate and significant. Business Analysis and Project Management: - Oversee requirements gathering and development for data services/data warehousing projects to ensure quality delivery of projects on time and within budget. - Drive success through high volume, demanding, business critical projects over numerous project deliverables and tight timelines. - Work with internal and external customers to assess the readiness of the business for development, integration and implementation for data service initiatives - Drive change management process and process improvements to drive execution in data warehousing and business intelligence - Oversee and monitor release management - Review, formulate and execute product development roadmaps Engineering, Architecture and Production - Ensure application development is aligned against global and regional business and technology strategies and needs. - Oversee technical delivery ensuring that product plans and specifications are supported by complete, solid engineering and execution strategy. - Oversee and Manage application service quality and production readiness through timely issue escalation and resolution. Qualifications The ideal candidate will be a proponent for innovation, best practices, sound design, strong development habits, and efficient team/project structures. Quintiles Information Technology offers a world class, global organization with ample career development and opportunity. As a Product Manager, the incumbent will have overall responsibility for a large team Minimum Requirements: - BS degree preferred; MS degree highly preferred - 15 years of total experience with 7 years of strong data background with a minimum of 10 years in a data oriented technical and/or managerial role - Prior back ground in leading / managing large scale data/information integration programs at a medium or large sized company - Pharma/Life Science/Clinical Research background strongly preferred but not required - 5 years of management experience, preferably in global and remote environments and preferably in data services Technical Skills - Prior experience in driving and implementing data governance and data quality improvement platforms - Strong knowledge in Data Warehouse concepts, methodologies and techniques. - Experience with full lifecycle development projects and agile methodologies - Familiarity with emerging technologies and software development best practices, particularly related to Meta Data, Reference Data & Master Data Development - Strong knowledge of data modeling, profiling and ETL methodologies and experience in implementing related techniques and tools. - Working knowledge of business intelligence platforms, BI data marts design & implementation. - Knowledge of Business Objects, Crystal Reports and other enterprise reporting tools. Soft Skills - Strong leadership skills - Considered a thought leader by peers - Strong people management skills; with a key interest and focus on mentoring and coaching teams. - Ability to develop and sustain effective working relationships. - Strategic / big picture thought process, but also detail-oriented with a focus on operational success. - Able to drive success in global partnerships and functional teams - Adopts a consultative approach to problem solving - Strong initiative - Excellent project management skills - Ability to build, lead and interact with a diverse, global project team comprised of individuals with different skill sets and levels of expertise - Excellent verbal and written communication skills - Ability to travel globally as needed (less than 10%)2012-02-20 08:26:21United StatesQuintilesNorth Carolina1203250NCDurham, NC26620329http://quintiles.jobs/xml/26620329/jobUSANew York CityTitle: Site Support Engineer I/II Location: USA-New York-New York City Other Locations: Come see why Quintiles has been listed on Computerworld's 2008, 2009 and 2011 lists of "Best Places to Work in IT"! Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visitwww.quintiles.com. Apply now for our Site Support Engineer position in our New York office. Depending on experience, this may be filled as a Site Support Engineer I or II. PURPOSE Provide Information Technology (IT) support to end users to restore service and/or identify and correct core problem. This job description differs from the formal job description in PeopleSoft in that it offers additional job requirement details to assist staff providers in the recruiting of more qualified candidates. RESPONSIBILITIES · Recreate user problems to resolve operating difficulties and recommend system modifications to reduce user problems. · Responsible for meeting specified service level standards · Escalate more complex problems to appropriate level of management and provide information on problems that are severe in nature or that exceed target dates · Provide training and advice to other less experienced, knowledgeable team members · Utilize and augment, as needed, technical support documentation and training materials · Adhere to established IT policies, procedures and standards and ensure conformance with information systems goals and procedures · Participate on global and regional project teams as needed · Maintain a thorough working knowledge of the day-to-day operating environment, available tools, and client applications. Also, maintain a working knowledge of Service Desk and IT Operations procedures related to client services. · Research, implement and maintain support technologies as needed. · Perform other duties as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Working knowledge of Microsoft server, workstation/laptop and networking technologies, Outlook, VPN, Active Directory, etc. · Working knowledge of Microsoft Office Suite 2007, MS Outlook, and other enterprise-wide desktop-centric applications · Understanding and ability to execute best practice desktop management in support of electronic mail management, data backup/recovery, memory management, etc. · Working knowledge of Citrix Metaframe and/or other thin client technologies · Ability to effectively troubleshoot desktop issues and resolve in timely fashion · Working knowledge of networked, shared printing environments · Working knowledge of support of multi-function print/scan/copy/fax platform support is a plus · Working knowledge of digital and IP-based phone system operations and support is a plus · Working knowledge of basic audio-visual, video & webconferencing is a plus · Working knowledge in support of mobile device/Blackberry, or cellular equivalent data/voice devices · Working knowledge of industry standards with regards to system and network administration · Possess excellent verbal and written communication skills · Ability to establish and maintain effective working relationships with coworkers, managers and clients · Must be able to take direction and also work independently, respectively · Project management skills/experience MINIMUM EDUCATION AND EXPERIENCE · Highly prefer a Bachelor's Degree in Computer Science or related field; · 3 years experience in PC software (Microsoft operating systems and applications suites, email systems, etc.) within a network environment · A and other Microsoft certifications are a plus · A minimum of 3 years end-user desktop support experience2012-02-16 07:47:14United StatesQuintilesNew York1202852NYNew York City, NY26558421http://quintiles.jobs/xml/26558421/jobUSABostonTitle: Clinical Research Associate / CRA / Senior CRA / Northeast Region, Oncology/Hematology ~ Location: USA-Massachusetts-Boston Other Locations: USA-West Virginia-Morgantown, USA-New Jersey-Princeton, USA-Connecticut-Waterbury, USA-New Jersey-Parsippany, USA-Connecticut-New Britain, USA-Connecticut-Norwich, USA-New Jersey-Piscataway, USA-Connecticut-Danbury, USA-Maine, USA-Virginia-Manassas, USA-Connecticut-Meriden, USA-New Jersey-Jersey City, USA-Maryland, USA-Pennsylvania-Wilkes Barre, USA-New York-Brooklyn, USA-New York-Bronx, USA-Connecticut, USA-West Virginia-Charleston, USA-New York-Ithaca, USA-Pennsylvania-Scranton, USA-Pennsylvania-Philadelphia, USA-Pennsylvania-Pittsburgh, USA-Pennsylvania-Phoenixville, USA-New Jersey-Hackensack, USA-Connecticut-Hartford, USA-Connecticut-Stamford, USA-Virginia-Marion, USA-New Jersey-Brick, USA-New Jersey-Long Branch, USA-Maryland-Towson, USA-Virginia-Roanoke, USA-New Jersey-Newark, USA-Pennsylvania, USA-Maine-Portland, USA-New Jersey-Berkeley Heights, USA-New Jersey, USA-New Jersey-Marlton, USA-New Jersey-Freehold, USA-Maryland-Baltimore, USA-Maryland-Rockville, USA-West Virginia, USA-Virginia, USA-New York-Manhattan, USA-New York, USA-Pennsylvania-Williamsport, USA-New York-White Plains, USA-New Jersey-Toms River, USA-Pennsylvania-Langhorne, USA-Pennsylvania-Grove City, USA-Pennsylvania-Hazleton, USA-Pennsylvania-Harrisburg, USA-Virginia-Charlottesville, USA-Maine-Pittsfield, USA-Maine-Bangor, USA-Virginia-Northern Virginia, USA-Maine-Concord, USA-Virginia-Richmond, USA-Virginia-Abingdon, USA-Maryland-Gaithersburg, USA-Virginia-Fairfax, USA-Virginia-Virginia Beach, USA-Maryland-Frederick, USA-Virginia-Reston, USA-New York-Schenectady, USA-New York-Binghamton, USA-New York-Westchester, USA-New York-Syracuse, USA-New York-Rochester, USA-New York-Long Island, USA-New York-Hawthorne, USA-New York-Buffalo, USA-New York-New York City, USA-New York-Albany, USA-Maryland-Hagerstown, USA-Virginia-Norfolk, USA-Maryland-Salisbury, USA-Virginia-Falls Church, USA-Maryland-Waldorf, USA-Virginia-Arlington, USA-West Virginia-Beckley, USA-New York-New City, USA-West Virginia-Wheeling, USA-New York-Liverpool, USA-New Jersey-Trenton, USA-Pennsylvania-Allentown Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We currently have an opening for a CRA with extensive Oncology monitoring experience. Can be located anywhere in the NE region. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience - Phase I Oncology experience preferred -2 years experience monitoring Oncology studies - Sound knowledge of medical terminology and clinical monitoring process - In depth therapeutic and protocol knowledge as provided in company training -Ability to perform regionalized travel an average of 65%, depending on project needs - Excellent verbal and written communications skills -Excellent interpersonal and organizational skills and attention to detail - Computer literacy, proficiency in MS Office2012-02-16 07:47:12United StatesQuintilesMassachusetts1203054MABoston, MA26558416http://quintiles.jobs/xml/26558416/jobUSABostonTitle: Clinical Research Associate / CRA / Senior CRA / Boston ~ Location: USA-Massachusetts-Boston Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:47:02United StatesQuintilesMassachusetts1202937MABoston, MA26558385http://quintiles.jobs/xml/26558385/jobUSANewarkTitle: Clinical Research Associate / CRA / Senior CRA / New Jersey ~ Location: USA-New Jersey-Newark Other Locations: USA-New Jersey-Brick, USA-New Jersey-Long Branch, USA-New Jersey-Marlton, USA-New Jersey-Freehold, USA-New Jersey-Toms River, USA-New Jersey-Princeton, USA-New Jersey-Parsippany, USA-New Jersey-Piscataway, USA-New Jersey-Jersey City, USA-New Jersey-Hackensack, USA-New Jersey-Berkeley Heights, USA-New Jersey-Trenton Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience -Customer service orientation - Sound knowledge of medical terminology and clinical monitoring process - In depth therapeutic and protocol knowledge as provided in company training -Ability to perform regionalized travel an average of 65%, depending on project needs - Excellent verbal and written communications skills - In depth therapeutic and protocol knowledge as provided in company training -Excellent interpersonal and organizational skills and attention to detail - Computer literacy, proficiency in MS Office2012-02-16 07:47:02United StatesQuintilesNew Jersey1202939NJNewark, NJ26558388http://quintiles.jobs/xml/26558388/jobUSABostonTitle: Clinical Research Associate / CRA / Senior CRA / Northeast ~ Location: USA-Massachusetts-Boston Other Locations: USA-West Virginia-Morgantown, USA-New Jersey-Princeton, USA-Connecticut-Waterbury, USA-New Jersey-Parsippany, USA-Connecticut-New Britain, USA-Connecticut-Norwich, USA-New Jersey-Piscataway, USA-Connecticut-Danbury, USA-Rhode Island, USA-Maine, USA-Connecticut-Meriden, USA-New Jersey-Jersey City, USA-Maryland, USA-Pennsylvania-Wilkes Barre, USA-New York-Brooklyn, USA-New York-Bronx, USA-Connecticut, USA-West Virginia-Charleston, USA-New York-Ithaca, USA-Pennsylvania-Scranton, USA-Pennsylvania-Philadelphia, USA-Pennsylvania-Pittsburgh, USA-Pennsylvania-Phoenixville, USA-New Jersey-Hackensack, USA-Connecticut-Hartford, USA-Connecticut-Stamford, USA-New Jersey-Brick, USA-VT-Burlington, USA-New Jersey-Long Branch, USA-Vermont, USA-Maryland-Towson, USA-New Jersey-Newark, USA-Pennsylvania, USA-Maine-Portland, USA-New Jersey-Berkeley Heights, USA-New Jersey, USA-New Jersey-Marlton, USA-New Jersey-Freehold, USA-Maryland-Baltimore, USA-Maryland-Rockville, USA-West Virginia, USA-New York-Manhattan, USA-District of Columbia-Washington, USA-New York, USA-Pennsylvania-Williamsport, USA-District of Columbia, USA-New York-White Plains, USA-New Jersey-Toms River, USA-New Hampshire-Keene, USA-Pennsylvania-Langhorne, USA-New Hampshire-Berlin, USA-Pennsylvania-Grove City, USA-New Hampshire-Lebanon, USA-Pennsylvania-Hazleton, USA-Pennsylvania-Harrisburg, USA-New Hampshire, USA-Maine-Pittsfield, USA-Maine-Bangor, USA-New Hampshire-Manchester, USA-Maine-Concord, USA-New Hampshire-Portsmouth, USA-Maryland-Gaithersburg, USA-New Hampshire-Nashua, USA-Maryland-Frederick, USA-New York-Schenectady, USA-Rhode Island-Providence, USA-New York-Binghamton, USA-New York-Westchester, USA-New York-Syracuse, USA-New York-Rochester, USA-New York-Long Island, USA-New York-Hawthorne, USA-New York-Buffalo, USA-New York-New York City, USA-New York-Albany, USA-Maryland-Hagerstown, USA-Maryland-Salisbury, USA-Maryland-Waldorf, USA-West Virginia-Beckley, USA-New York-New City, USA-West Virginia-Wheeling, USA-New York-Liverpool, USA-New Jersey-Trenton, USA-Pennsylvania-Allentown Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:45United StatesQuintilesMassachusetts1203091MABoston, MA26558357http://quintiles.jobs/xml/26558357/jobUSADoverTitle: Clinical Research Associate / CRA / Senior CRA / Delaware ~ Location: USA-Delaware-Dover Other Locations: USA-Delaware-Wilmington Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:44United StatesQuintilesDelaware1203090DEDover, DE26558354http://quintiles.jobs/xml/26558354/jobUSAShreveportTitle: Pharmaceutical Sales Representative - Internal Medicine Shreveport, LA 6517 Location: USA-Louisiana-Shreveport Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for Internal Medicine Pharmaceutical Sales Representatives to join our team of over 10,000 global field representatives in several regions making o v er 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Internal Medicine Pharmaceutical Sales Representative The primary objective of the sales representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor degree required · Prior sales experience is required · Minimum 3 years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, large account management or business to business experience is preferred · Excellent written and oral communication skills required · Ability to travel as necessary (some overnights and weekends) is required · Prior experience in pain management, cardiovascular and/or metabolic/diabetes therapeutic area, gastrointestinal disorders and therapies or other internal medicine areas preferred · Documented sales results · Participation in management development program preferred · Residence within the current geography or willingness to relocate to the current geography is required Competencies · Performance and results driven · Customer expertise · Professional credibility · Business Insight · Collaboration · Thrives in Ambiguity2012-02-16 07:46:39United StatesQuintilesLouisiana1203063LAShreveport, LA26558342http://quintiles.jobs/xml/26558342/jobUSABaltimoreTitle: Clinical Research Associate / CRA / Senior CRA / Maryland ~ Location: USA-Maryland-Baltimore Other Locations: USA-Maryland-Towson, USA-Maryland-Rockville, USA-Maryland-Gaithersburg, USA-Maryland-Frederick, USA-Maryland-Hagerstown, USA-Maryland, USA-Maryland-Salisbury, USA-Maryland-Waldorf Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:35United StatesQuintilesMaryland1203081MDBaltimore, MD26558327http://quintiles.jobs/xml/26558327/jobUSAWashingtonTitle: Clinical Research Associate / CRA / Senior CRA / Washington, DC ~ Location: USA-District of Columbia-Washington Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:32United StatesQuintilesDistrict Of Columbia1203089DCWashington, DC26558315http://quintiles.jobs/xml/26558315/jobUSANew York CityTitle: Clinical Research Associate / CRA / Senior CRA / New York ~ Location: USA-New York-New York City Other Locations: USA-New York-Westchester, USA-New York-White Plains, USA-New York-Syracuse, USA-New York-Rochester, USA-New York-Long Island, USA-New York-Hawthorne, USA-New York-Buffalo, USA-New York-Albany, USA-New York-Brooklyn, USA-New York-Bronx, USA-New York-New City, USA-New York-Liverpool, USA-New York-Ithaca, USA-New York-Schenectady, USA-New York-Manhattan, USA-New York-Binghamton, USA-New York Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:30United StatesQuintilesNew York1203086NYNew York City, NY26558310http://quintiles.jobs/xml/26558310/jobUSAArlingtonTitle: Clinical Research Associate / CRA / Senior CRA / Virginia ~ Location: USA-Virginia-Arlington Other Locations: USA-Virginia-Marion, USA-West Virginia-Morgantown, USA-Virginia-Roanoke, USA-Virginia-Norfolk, USA-Virginia-Manassas, USA-Virginia-Falls Church, USA-West Virginia-Beckley, USA-West Virginia-Wheeling, USA-Virginia-Charlottesville, USA-West Virginia-Charleston, USA-Virginia-Northern Virginia, USA-Virginia-Richmond, USA-West Virginia, USA-Virginia-Abingdon, USA-Virginia-Fairfax, USA-Virginia-Virginia Beach, USA-Virginia-Reston, USA-Virginia Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:30United StatesQuintilesVirginia1203088VAArlington, VA26558306http://quintiles.jobs/xml/26558306/jobUSAPhiladelphiaTitle: Clinical Research Associate / CRA / Senior CRA / Pennsylvania ~ Location: USA-Pennsylvania-Philadelphia Other Locations: USA-Pennsylvania-Langhorne, USA-Pennsylvania-Grove City, USA-Pennsylvania-Hazleton, USA-Pennsylvania-Harrisburg, USA-Pennsylvania, USA-Pennsylvania-Scranton, USA-Pennsylvania-Pittsburgh, USA-Pennsylvania-Phoenixville, USA-Pennsylvania-Wilkes Barre, USA-Pennsylvania-Williamsport, USA-Pennsylvania-Allentown Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-16 07:46:29United StatesQuintilesPennsylvania1203087PAPhiladelphia, PA26558303http://quintiles.jobs/xml/26558303/jobUSACambridgeTitle: Research Assistant - Outcome Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. This is an ENTRY level position Organize and help manage research projects, including development of study protocols and data collection methods, arrangement and attendance of project meetings, and travel to client sites as needed. Primary Responsibilities: * Assist in preparation of abstract, manuscripts and oral presentations. * Work closely with project managers and other members of Scientific Affairs department writing, revising, and executing research protocols. * Responsibilities include data and document review, information management, and performing critical, systematic literature review and provide summaries as needed * Develop slides and posters for presentation of project results at regional and national meetings. * Bachelors in Science required, Masters Degree in public health, epidemiology or a relevant scientific field preferred. * 1 year in healthcare or biopharmaceutical industry with experience coordinating research preferred, equivalent work experience may be considered. * Strong written and verbal communication skills (medical writing experience a plus) * Exceptional organization, follow up and strong detail orientation * Ability to manage multiple tasks * Excellent technical, analytical, computer, organizational, and problem-solving skills, strong interpersonal and communication skills, * Ability to work independently, under supervision and as part of a team * Microsoft Office including Excel and PowerPoint required.2012-02-16 07:46:18United StatesQuintilesMassachusetts1202793MACambridge, MA26558268http://quintiles.jobs/xml/26558268/jobUSAOverland ParkTitle: Clinical Project Manager, Pharmaceutical Research Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Phase I Services division of Quintiles is seeking an enthusiastic Project Manager. Quintiles offers excellent training, career development, global opportunities and work schedule flexibility. The Project Manager will manage single and full service clinical projects that are both regional and global in scope. The Project Manager will lead the cross functional project teams including clinical operations, data management, biostatistics, medical writing and clinical QA, to ensure quality, on-time and within budget deliverables for primarily Phase I-IIa clinical trials. Specific responsibilities may include: managing the clinical study timelines, deliverables and risks, working with the client and Business Services to finalize the project budget and scope, serving as primary contact with client to ensure appropriate communication, managing project budget, and participate in internal and external meetings. * 2 years in Project Management environment * 5 years of clinical research or related relevant experience * Experience in a key CRO/Pharmaceutical operational function, e.g., data management, clinical operations, laboratory, pre-clinical * Strongly prefer candidates with solid Phase I-IIa management experience * Experience with resource and budget/financial management * Good written & oral communication skills * Good client management skills * Strong computer/technology skills including MS Excel, PowerPoint, and MS Project (or other similar Project Management tools) * Knowledge of clinical study guidelines including FDA, ICH & GCP * Ideal candidate will have a firm grasp of the clinical trials process2012-02-16 07:46:01United StatesQuintilesKansas1201878KSOverland Park, KS26558230http://quintiles.jobs/xml/26558230/jobUSAResearch Triangle ParkTitle: Associate Director, Head of Infosario Data Factory Support Location: USA-North Carolina-Research Triangle Park Other Locations: Why Quintiles? A career atQuintilesputs you at the corporate center of the leading worldwide pharmaceutical services organization. We been named to the 2008, 2009 and 2011 lists ofComputerworld's "100 Best Places to Work in IT". Quintiles IT was also listed as the leading company for the pharmaceutical industry on the 2011 "InformationWeek 500"and ranked within the top five overall! If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. We are seeking dynamic, highly motivated and results focused individuals that take an innovative and consultative approach to driving and achieving success. Apply now for our Associate Director, Head of Infosario Data Factory Support position located in our Morrisville, NC office. The Associate Director of Infosario Data Factory Product Support will be responsible for overseeing and managing all application/system support functions for the Infosario Data Factory product team.. This position will manage multiple product support team staff globally and ensure that the support group meets or exceeds the project and service level target expectations. The Product Support AD will serve as a key member of the Infosario Customer and Product Support organization and will be the primary point of contact to the Data Factory Product team. The AD also sits on the product's leadership team and will collaborate extensively with the BA, Development and Testing heads as well as directly with business stakeholders. The successful candidate will have proven experience and success in implementing support triage processes and metrics as well as proactive plans for monitoring and business services. Experience supporting external B2C systems and data warehouses, ETL and related technologies essential.. Candidates with experience in the pharmaceutical and clinical trials industry will receive priority consideration for interviews. This is a high visibility role requiring excellent communication, organization, attention to detail and negotiation/influence skills. Responsibilities: · Provides supervision, leadership, and direction to other department leaders, managers, staff, projects, and other key initiatives within the Global Product Support department. Collaborates with Service Owners, business leaders, end users, other IT departments, and software vendors to develop and provide appropriate support strategies for regional and global business applications. Assists in the vendor and product selection process and identifies new technologies and assists in the determination of support requirements. Assists in the development and direction of Product Support through budget development, and process development/improvement for technical and business processes. May also provide technical leadership and ensure appropriate planning for the deployment of key systems and applications and is able to work at a high level of technical competency. Drives the development and adoption of processes and direction for the Product Support department. · Acts as formal line manager for IT staff and/or other leaders/managers including setting goals, appraisal of staff performance, and development needs. · Support staff to achieve their training and development objectives and identify areas the team needs to develop to meet future business needs. · Match available resources with business demand and identify resource requirements to meet future business needs. · Provide input to budgets as required and control expenditure to achieve financial objectives. · Develop and review methods to assess quality and efficiency of work performed by team, including metrics, internal process improvement, Work Instructions, and SOPs. Ensure Computer Systems Validation procedures are followed. · Ensure all finance and HR activities are managed according to Quintiles procedures and guidelines. · Maintain knowledge of Quintiles services and of the IT industry, analyze the abilities of tools and technologies and compare with the needs of the business, recommend potential solutions to managers within the business. · Contribute to the development of IT strategy documentation and input into business strategy documentation, in support of specified business units. · Review IT strategy with staff and create tactical/operational plans and supporting application architecture. · Validate strategic and operational plan with senior management. · Compare competing needs and benefits against existing work and strategies. · Coordinate in the selection of hardware and software including due diligence activities. · Higly prefer a Bachelors Degree in Computer Science, Engineering, or a scientific field with eight or more years of progressive management experience in system support, operations, and engineering. Will also consider non-technical Bachelor's degree with related professional experience of 12 years or more in IT disciplines · Two years of which must be in a global / multi-national role · Strong leadership skills · Experience managing in a global environment. · Experience in budget formulation and cost management. · Experience managing in a highly regulated computing environment · Must possess excellent aural, oral, and written communications skills, to include technical writing/editing.2012-02-16 07:45:57United StatesQuintilesNorth Carolina1202031NCResearch Triangle Park, NC26558217http://quintiles.jobs/xml/26558217/jobUSAParsippanyTitle: Sr Statistical Programmer - SDTM / ADaM - Office based or Homebased in US or Canada Location: USA-New Jersey-Parsippany Other Locations: CAN-Quebec-Montreal Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. Quintiles is seeking enthusiastic Senior Statistical Programmers with SDTM and ADaM programming skills to join our GFR Biostatistics team. Position can be Homebased or Officebased anywhere in the United States or Canada. Candidates may also be hired at the Statistical Programming Scientist or Statistical Programmer 2 level depending on the experience of the candidate The Sr. Statistical Programmer will provide experienced technical expertise as part of the Statistical Programming (SP) team to develop process methodology for department to meet internal and external clients' needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical analysis needs. Provide technical expertise and leadership to the Statistical Programming department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements. RESPONSIBILITIES • Program, plan and co-ordinate the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks. • Program and plan the integration of databases from multiple studies or sources. • Develop, plan, and co-ordinate programming documentation including plans and specifications, as appropriate, for complex studies. • Perform, plan and co-ordinate the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of lead for single complex studies or group of studies. • Manage project budget and resource requirements and provide training/guidance to lower level staff. • Masters degree or educational equivalent in computer science or related field and 3 years relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 4 years relevant experience; or equivalent combination of education, training and experience • Knowledge of CDISC, SDTM and ADaM Programming • Knowledge of statistics and/or clinical drug development process • Knowledge of electronic submissions (including: knowledge of data submission structures and requirements; experience in creating relevant hyperlinks, etc) • Advanced knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities.2012-02-13 10:22:51United StatesQuintilesNew Jersey1202802NJParsippany, NJ26485370http://quintiles.jobs/xml/26485370/jobUSAOmahaTitle: Clinical Research Associate / CRA / Sr CRA / Omaha NE~ Location: USA-Nebraska-Omaha Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the Omaha, NE area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-13 10:22:49United StatesQuintilesNebraska1202831NEOmaha, NE26485368http://quintiles.jobs/xml/26485368/jobUSASaint LouisTitle: Clinical Research Associate / CRA / Sr CRA / St. Louis MO~ Location: USA-Missouri-Saint Louis Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the St Louis area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-13 10:22:48United StatesQuintilesMissouri1202832MOSaint Louis, MO26485367http://quintiles.jobs/xml/26485367/jobUSAHawthorneTitle: Life Sciences Consultant, Managed Markets Location: USA-New York-Hawthorne Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Quintiles Consulting is currently seeking a Life Sciences Consultant focused on Managed Markets. Specific responsibilities to the role may include: * Assist in managing client engagements * Prepare client presentations * Participate in the design project research, analysis, and reporting techniques * Team with Engagement Managers regarding the development of project research materials including analysis plans, surveys, discussion guides, and other data collection instruments * Analysis and interpretation of data * Production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, etc. * Contribute to proposal writing Sample Engagements Include: * Market assessment, evaluation and forecasting * Market research * Pricing and reimbursement strategy development and support * Product positioning and development * Scenario planning * Bachelor's degree required * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * 2-3 years in Consulting, with a preference for Life Sciences Consulting focused on the U.S. payer environment OR 2-3 years in a role in biopharma company focused on the U.S. payer environment (e.g., Managed Markets, Payer Strategy, Account Management, Market Access) * Superior analytical, communication, and presentation skills (sample will be required)2012-02-10 10:45:28United StatesQuintilesNew York1202822NYHawthorne, NY26451540http://quintiles.jobs/xml/26451540/jobUSAHawthorneTitle: Clinical/Public Health Consultant, Patient Reported Outcomes Location: USA-New York-Hawthorne Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Specific responsibilities to the role may include: * Assist in managing client engagements * Prepare client presentations * Participate in the design project research, analysis, and reporting techniques * Team with Engagement Managers regarding the development of project research materials including protocols, analysis plans, surveys, discussion guides, and other data collection instruments * Analysis and interpretation of clinical data * Production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, abstracts, manuscripts, and product dossiers * Contribute to proposal writing Sample Engagements Include: * Market assessment, evaluation and forecasting * Pricing and reimbursement strategy development and support * Health economic evaluations and health technology assessments * Product positioning and development * Therapeutic and technical support * Applied epidemiologic investigations * Disease area reviews and modeling * Value dossier development * Quality of Life studies * Bachelor's degree required * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * 2-4 years in Consulting, with a preference in Life Sciences Consulting with a clinical/public health background * Must have PRO (patient reported outcome) and/or survey research background * Medical, clinical literature review experience * Superior analytical, communication, and presentation skills (sample will be required) * Has experience and abilities in the following areas: research and development, clinical development, product development, commercialization of drugs (a plus), technical writing, and presentation skills * Ability to travel to the client site as necessary2012-02-10 10:45:28United StatesQuintilesNew York1202823NYHawthorne, NY26451539http://quintiles.jobs/xml/26451539/jobUSANoneTitle: *Clinical Project Manager / Sr. Clinical Project Manager - Rheumatology Location: United States Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE We are recruiting for a Clinical Project Manager specializing in Rheumatology to join our Clinical Project Management Department.Manage the execution of the assigned regionally-based clinical study(ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES ? Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. ? Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. ? Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. ? Collect information on team performance against contract, customer expectations, and project baselines. ? Lead problem solving and resolution efforts to include management of risk, contingencies and issues. ? Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. ? Provide input for the development of proposals for new work and manage project budgets. ? Provide input to line managers of their project team members' performance relative to project tasks. ? Prepare and present project information at internal and external meetings. ? Participate in proposal development and in the bid-defense process with guidance and supervision. ? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. * Project Management experience with Rheumatology studies is required REQUIRED KNOWLEDGE, SKILLS AND ABILITIES ? In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines ? Good therapeutic and protocol knowledge ? Strong communication and interpersonal skills, including good command of English language ? Good problem solving skills ? Demonstrated ability to deliver results to the appropriate quality and timeline metrics ? Good teamwork skills ? Excellent customer service skills ? Good presentation skills ? Good judgment ? Strong software and computer skills, including MS Office applications ? Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-02-10 10:44:58United StatesQuintilesNone1202652NoneVirtual, USA26451484http://quintiles.jobs/xml/26451484/jobUSAResearch Triangle ParkTitle: Analyst, Clinical Data Programming - InForm Location: USA-North Carolina-Research Triangle Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We have an exciting opportunity for an Analyst, Clinical Data Programming or Programmer/Analyst, Clinical Data Programming to support our InForm Programming team in Raleigh, NC. PURPOSE Provide advanced technical expertise as part of a team to develop and maintain clinical systems to meet internal and external client needs. Plan and coordinate database design and development for local, regional, or transnational use. Provide leadership to the Clinical Data Programming department in the area of technical expertise. RESPONSIBILITIES • Serve as Lead Programmer on the corporate team. • Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems. • Provide technical expertise in conjunction with internal and external clients. • Program, test, and document databases in accordance with programming standards and validation procedures. • Program database manipulation and transfers of data for internal and external clients. • Mentor other team members and Lead Programmers in training and developing technical and/or database expertise. • Independently bring project solutions to the CDP teams and the Clinical Data Programming department. • May assist IT in developing and implementing new technologies. • May assist IT in testing and evaluating new upgrades to technologies. • May assist in developing, revising, and maintaining core operating procedures and working instructions. • Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables. • Develop and maintain good communications and working relationships with teams and external clients. • Bachelor's degree, or educational equivalence, in computer/life science or related field with 3 years of relevant work experience; or equivalent combination of education, training and experience • Excellent knowledge of Oracle and/or SAS • Expertise in building/configuring EDC studies • InForm Architect and Central Designer experience preferred • Understanding of InForm post-production change techniques and processes • Solid understanding of clinical drug development process • Excellent organizational, communication, and technical database skills • Ability to establish and maintain effective working relationships with coworkers, managers and clients • Extensive use of telephone and face-to-face communication requiring accurate perception of speech • Extensive use of keyboard requiring repetitive motion of fingers • Regular sitting for extended periods of time2012-02-10 10:43:37United StatesQuintilesNorth Carolina1201470NCResearch Triangle Park, NC26451392http://quintiles.jobs/xml/26451392/jobUSASeattleTitle: Clinical Research Associate / CRA / Sr CRA / NorthWest United States ~ Location: USA-Washington-Seattle Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Prefer BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-08 11:32:03United StatesQuintilesWashington1202613WASeattle, WA26402652http://quintiles.jobs/xml/26402652/jobUSASan DiegoTitle: Clinical Research Associate / CRA / Sr CRA / San Diego CA ~ Location: USA-California-San Diego Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-08 11:32:03United StatesQuintilesCalifornia1202614CASan Diego, CA26402653http://quintiles.jobs/xml/26402653/jobUSALos AngelesTitle: Clinical Research Associate / CRA / Sr CRA / California ~ Location: USA-California-Los Angeles Other Locations: USA-California-San Diego, USA-California-San Francisco Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-08 11:32:02United StatesQuintilesCalifornia1202610CALos Angeles, CA26402650http://quintiles.jobs/xml/26402650/jobUSALos AngelesTitle: Clinical Research Associate / CRA / Sr CRA / Los Angeles ~ Location: USA-California-Los Angeles Other Locations: USA-California-San Diego, USA-California-San Francisco Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. - Prefer BS/BAor RN - At least2 yrs site monitoring experience. - Oncology experience preferred. -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-08 11:32:02United StatesQuintilesCalifornia1202611CALos Angeles, CA26402648http://quintiles.jobs/xml/26402648/jobUSASan FranciscoTitle: Clinical Research Associate / CRA / Sr CRA / SF/Oakland ~ Location: USA-California-San Francisco Other Locations: USA-California-Oakland Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. The Clinical Research Associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending upon experience and may include customer-managed clients. - Prefer BS/BA. - 3 years monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-08 11:32:02United StatesQuintilesCalifornia1202615CASan Francisco, CA26402651http://quintiles.jobs/xml/26402651/jobUSAClevelandTitle: Clinical Research Associate/ Sr CRA - Ohio — Cleveland area~ Location: USA-Ohio-Cleveland Other Locations: USA-Ohio Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Cleveland, OH! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at an entry level CRA, CRA or Sr. CRA level depending on experience and may include customer-managed clients. Should have oncology experience. - BS a Must -Must live in theCleveland Ohio area -Oncology experience a must -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-08 11:30:30United StatesQuintilesOhio1202549OHCleveland, OH26402533http://quintiles.jobs/xml/26402533/jobUSAChicagoTitle: Clinical Research Associate / CRA / Sr CRA / Chicago~ Location: USA-Illinois-Chicago Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs monitoring experience or combination of on-site monitoring and clinical research coordinator experience. - Oncology experience - Must be located inChicago - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-06 08:26:20United StatesQuintilesIllinois1202443ILChicago, IL26327628http://quintiles.jobs/xml/26327628/jobUSAColumbusTitle: Clinical Research Associate / CRA / Sr CRA / Columbus~ Location: USA-Ohio-Columbus Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the Columbus, OH area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-06 08:25:41United StatesQuintilesOhio1202478OHColumbus, OH26327601http://quintiles.jobs/xml/26327601/jobUSANoneTitle: *Clinical Project Manager / Sr. Clinical Project Manager - Internal Medicine Location: United States Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE We are recruiting for a Clinical Project Manager specializing in Internal Medicine to join our Clinical Project Management Department.Manage the execution of the assigned regionally-based clinical study(ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES ? Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. ? Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. ? Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. ? Collect information on team performance against contract, customer expectations, and project baselines. ? Lead problem solving and resolution efforts to include management of risk, contingencies and issues. ? Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. ? Provide input for the development of proposals for new work and manage project budgets. ? Provide input to line managers of their project team members' performance relative to project tasks. ? Prepare and present project information at internal and external meetings. ? Participate in proposal development and in the bid-defense process with guidance and supervision. ? Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. * Project Management experience with Internal Medicine studies is required REQUIRED KNOWLEDGE, SKILLS AND ABILITIES ? In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines ? Good therapeutic and protocol knowledge ? Strong communication and interpersonal skills, including good command of English language ? Good problem solving skills ? Demonstrated ability to deliver results to the appropriate quality and timeline metrics ? Good teamwork skills ? Excellent customer service skills ? Good presentation skills ? Good judgment ? Strong software and computer skills, including MS Office applications ? Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-02-06 08:25:35United StatesQuintilesNone1202470NoneVirtual, USA26327593http://quintiles.jobs/xml/26327593/jobUSAResearch Triangle ParkTitle: *Sr. Clinical Project Coordinator / Clinical Project Support Specialist Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Kansas-Overland Park Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are recruiting a Clinical Project Support Specialist / Senior Clinical Project Coordinator within General Medicine to provide project related support and assistance for assigned projects and project teams with minimal supervision. You will ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. This position will be office based in Research Triangle Park, NC or Overkland Park, KS. RESPONSIBILITIES * Establish and maintain all project documentation including all files, records and reports according to the scope of work and SOPS. * Assist with periodic review/audit of files for accuracy and completeness. * Coordinate and track all information, communications, documents, materials and supplies for assigned projects. * Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information. * Identify and escalate discrepancies in project tracking data, timesheet coding, expense data billing, interpretation of financial figures which may lead to identification of out of scope activities not previously reported. * Prepare and distribute status, tracking and project finance reports, and assist the project manager(s) with budget allocation and approval of invoices. * Prepare presentation materials for meetings (internal/external) and project summary data. * Coordinate project team and/or customer meetings including logistics and materials required. * Coordinate with other project support staff within and outside the Clinical Project Management Unit to identify and consolidate support processes. * Will serve as primary backup contact for internal project team and for external stakeholders/customers as designated by project manager. * Will undertake clinical project management activities as directed by the clinical project manager. * Train and mentor more junior project support staff. MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's Degree and relevant experience; or equivalent combination of education, training and experience. * Experience in a clinical support role is required * Experience of the following would be advantageous: audit / regulatory inspections, monitoring visits (initiations - closure), ICF / study documentation development, submission process to Regulatory bodies or Ethics Committees, study file maintenance and liaising with Customer and external vendors. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Good communication and interpersonal skills * Good problem solving skills * Results and detail-oriented approach to work delivery and output * Good planning, time management and prioritization skills * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients.2012-02-06 08:25:35United StatesQuintilesNorth Carolina1202475NCResearch Triangle Park, NC26327590http://quintiles.jobs/xml/26327590/jobUSAMinneapolisTitle: Clinical Research Associate / CRA / Sr CRA / Minneapolis~ Location: USA-Minnesota-Minneapolis Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the Minneapolis, Minnesota area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-06 08:25:34United StatesQuintilesMinnesota1202456MNMinneapolis, MN26327585http://quintiles.jobs/xml/26327585/jobUSADetroitTitle: Clinical Research Associate / CRA / Sr CRA / Detroit~ Location: USA-Michigan-Detroit Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the Detroit, MI area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-06 08:25:34United StatesQuintilesMichigan1202458MIDetroit, MI26327588http://quintiles.jobs/xml/26327588/jobUSAClevelandTitle: Clinical Research Associate / CRA / Sr CRA / Cleveland~ Location: USA-Ohio-Cleveland Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr CRA level depending on experience and may include customer-managed clients. - BS/BA. - 2 yrs CRA monitoring experience - Oncology experience Preferred - Must be located in the Cleveland, OH area - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office. https://quintiles.taleo.net/careersection/q_us cra career section/joblist.ftl?lang=en2012-02-06 08:25:30United StatesQuintilesOhio1202462OHCleveland, OH26327580http://quintiles.jobs/xml/26327580/jobUSANoneTitle: Medical Writing Team Leader - Medical Communications - Berkshire Location: Great Britain Other Locations: United States Medical Writing Team Leader - Medical Communications - Berkshire Quintiles currently has an exciting opportunity for an experienced Medical Writer to join their Medical Communications agency, at a senior level. The ideal candidate for this role can either be based in our new offices in Berkshire or work from our US offices in Raleigh, NC or New Jersey. Managing a team of 4-5 writers you will have extensive experience as a writer in medical communications as well as proven experience in line management and ideally, have publication planning expertise, and experience of writing for a wide range of audiences/media. Successful candidates will be strategic thinkers, who are comfortable contributing to business development and presenting at pitches as well as being creative and driven. Quintiles Medical Communications is an international medical communications agency that develops and produces a broad range of communications programmes and materials on behalf of pharmaceutical industry. Working with our pharmaceutical clients, our activities include organising international symposia, developing educational programmes for physicians and patients, producing clinical trial investigator and participant support materials, and developing print/digital materials ranging from sales aids to peer-reviewed publications. Quintiles UK: Voted Top 50 Best Workplaces in the UK 2008-2011 Benefits: Excellent salary Car Allowance Life Assurance & Private Health Insurance Additional Voluntary Benefits available including: * Health (Dental, Health Screen and Optical) * Health Clubs and Gyms * Childcare Vouchers * Give As You Earn Key Skills/Experience: Extensive writing experience within a medical communications agency - essential Proven ability to manage a team, coaching/training/mentoring Extensive experience in medical writing, reviewing and resource planning Extensive experience with a wide range of medical communications materials, including publication planning, symposium and exhibition materials, pitch presentations and promotional materials (for a range of audiences) Excellent project/time management and organisational skills, with a proven track record of managing large medical communications programmes Ability to monitor team outputs, ensuring all written materials are of high scientific quality and meet client strategic marketing objectives Excellent interpersonal/communication skills, with demonstrated ability in coordinating and motivating staff to meet deadlines Flexible attitude - managing ever-changing priorities Familiarity with code of practice guidelines Excellent presentation skills Educated to degree level or equivalent in medicine, pharmacy, or life sciences (PhD preferred) Full eligibility to work in the UK2012-02-02 09:25:49United StatesQuintilesNone1202042NoneVirtual, USA26267384http://quintiles.jobs/xml/26267384/jobUSANoneTitle: Clinical Research Associate/ Sr CRA (Minneapolis, MN/Chicago, IL/Detroit, MI/St. Louis, MO) - oncology~ Location: USA-Michigan Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking an enthusiastic CRA to join the team for Minnesota! The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. Position will be filled at CRA or Sr. CRA level depending on experience and may include customer-managed clients. We are offering sign-on bonuses! - Must have BS. - Must be located inMinneapolis, MN/Chicago, IL/Detroit, MI/St. Louis, MO - 2 yearsClinical Experience in Oncology, nursing and/or clinical research coordinator -Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. -Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. -Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2012-02-02 09:24:30United StatesQuintilesMichigan1202358MIMichigan, USA26267359http://quintiles.jobs/xml/26267359/jobUSAResearch Triangle ParkTitle: Clinical Project Management (CPM) Director/Senior CPM Director, Clinical Project Management - Oncology Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta, USA-California-San Diego, USA-New Jersey-Parsippany, USA-Kansas-Overland Park Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seeking anClinical Project Management (CPM) Director/Senior CPM Director to work with our Oncology Therapeutic Delivery Unit. The CPM Director/Senior CPM Director will direct and manage large, global, multi functional projects or program, including the execution of the clinical component of the project/program to the Sponsor's satisfaction, ensuring quality deliverables, on time delivery and within budget. Has strategic decision-making responsibility for the project/program. Ensure that all project work is completed in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage the scope of work, objectives, quality of deliverables, and other project and study management activities. * Serve as primary project/program contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to. * Ensure the development of project plans for all phases of the project lifecycle, including the quality and risk management, ensuring that issue escalation and resolution is clear. * Develop proactive contingency plans to mitigate clinical risk across studies. * Work with Business Development to finalize the project/program budget and scope of work. * Direct and lead project activities for team members related to their project-oriented tasks to ensure that project/program milestones are met. * Continually review and make recommendations to ensure adequate resources are available to meet project deliverables and milestones * Develop, lead and implement continuous improvement for assigned projects and programs. * Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; implement plan following approval by senior management. * Accountable for the financial oversight and goals from projects, to meet company goals (realization targets), proactively ensuring adherence to change control processes. * Provide consultation to clients on drug development process, study management strategy, and plans as needed. * Participate in proposal and budget development, evaluate feasibility of potential programs and impact on company operations and goals, negotiate and make decisions on behalf of the organization. Participate in sales/proposal presentations in face-to-face meetings with potential clients. * Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison. Bachelor's degree in life sciences or related field and 12 years clinical research experience including 8 years project management/ leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience/ * Early Phase experience needed * In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes * Demonstrated financial management skills, including project financial tracking and accounting methods * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Excellent communication and interpersonal skills, including good command of English language , customer management skills and organization and problem-solving skills * Strong presentation skills * Ability to balance operational and strategic priorities * Proven ability to work through others to deliver results to the appropriate quality and timeline metrics * Strong influencing and negotiation skills * Highly effective team leadership skills * May require occasional travel.2012-02-01 08:58:53United StatesQuintilesNorth Carolina1202293NCResearch Triangle Park, NC26236668http://quintiles.jobs/xml/26236668/jobUSAResearch Triangle ParkTitle: Clinical Project Manager/Sr. Clinical Project Manager/Associate Director, Clinical Project Management - Oncology Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta, USA-California-San Diego, USA-New Jersey-Parsippany, USA-Kansas-Overland Park Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are seekingClinical Project Managers/Sr. Clinical Project Managers/Associate Directors to work with our Clinical Project Management Oncology Division. Theses roles will manage the execution of the assigned regionally-based clinical study (ies) per Contract, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles and ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. * Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. * Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to. * Collect information on team performance against contract, customer expectations, and project baselines. * Lead problem solving and resolution efforts to include management of risk, contingencies and issues. * Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. * Provide input for the development of proposals for new work and manage project budgets. * Provide input to line managers of their project team members' performance relative to project tasks. * Prepare and present project information at internal and external meetings. * Participate in proposal development and in the bid-defense process with guidance and supervision. * Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/visits and ongoing mentoring of CRA team. Bachelor's degree in life sciences or related field and 5 years' clinical research experience including 2 years' project management experience and experience in clinical operations; or equivalent combination of education, training and experience. * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Good therapeutic and protocol knowledge * Strong communication and interpersonal skills, including good command of English language * Good problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good teamwork skills * Excellent customer service skills * Good presentation skills * Good judgment * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients2012-02-01 08:58:53United StatesQuintilesNorth Carolina1202294NCResearch Triangle Park, NC26236669http://quintiles.jobs/xml/26236669/jobUSACambridgeTitle: *Sr.Software Engineer--Outcome--Pipeline Req. Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose:Participates in all aspects of the development of our web-based hosted, healthcare data management solutions. Primary Responsibilities: * Design, development and enhancement of health care application solutions following software development best practices * Work collaboratively with other departments including the client technical solutions, project management and software quality assurance testing teams in the definition and delivery of quality solutions that meet FDA 21 CFR Part 11 requirements * Ensure on time, quality deliverables and meeting project milestones and deadlines * Providing software estimations * Recommend and assist in implementing software process improvements Requirements: * 7-10 years experience developing Java/J2EE web-based applications on a Linux platform * Strong knowledge and experience with as many of the following APIs, extended components and frameworks as possible within the J2EE arena: Eclipse, Ant, JSP/Servlets, JDBC, JavaScript, Apache, Tomcat and test driven development using JUNIT * Experience with high volume SaaS application development * Strong SQL development experience, Oracle knowledge a plus * Experience with the Linux operating system * Excellent communication and interpersonal skills * BS in Computer Science or related. MS Preferred.2012-01-26 08:22:22United StatesQuintilesMassachusetts1118158MACambridge, MA26123519http://quintiles.jobs/xml/26123519/jobUSAMariettaTitle: Proposal Developer 1 Location: USA-Georgia-Marietta Other Locations: The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking an enthusiastic Proposal Developer to join our team! PURPOSE: Responsible for the preparation of text and budget for proposals, rebids, and related documents for managers' approval. Coordinates incoming comments from Operations and Project Management and ensures consistency between text and budget. Performs as a Team Leader on assigned projects. RESPONSIBILITIES: * Participates as a part of a dedicated team to ensure consistency in approach, metrics, and format for assigned customers as a team member. * Assists in the preparation, review and finalization of proposals/budgets. * Participates in resource calls with clients to discuss their needs. * Must be able to identify discrepancies in client information. * Solicits input from and effectively communicates all Customer information received to Quintiles' operational groups. * Routinely interacts with Quintiles' Operations, Project Management, Business Development, Finance, and Customers to prepare and finalize proposals. * Prepares proposal text and budgets, customizing all documents to accurately reflect services to be provided. * Oversees the finalization of documents and distributions to the customer and internal departments. * Serves as a lead for assigned customers; developing proposals and budgets. * Develops working relationships with customer contacts and responds to customer specific requirements. * Conducts verbal and/or written follow-up with clients after the submission of proposals as needed. * Updates and maintains corporate databases (GPRS) as required. * Ensures accurate information is included in tracking reports (specifically GPRS). * Reviews Requests for Proposal (RFPs) to identify necessary information for proposal budget development. * Participates in the development of department procedures and processes. * Attends and participates in Proposal/Contract Transition Meetings. * Attends and participates in Proposal Team meetings. * Performs quality controls edits on all documents. * Performs all other duties as assigned. * Bachelor's Degree in business management or other related field preferred, and a minimum of 3 years experience in marketing, business management/development, or proposal development, or other comparable combination of education, training and experience. * Possess excellent organizational skills and attention to detail. • Possess excellent communication skills, both verbal and written. * Possess strong interpersonal skills with the ability to manage multiple projects. * Ability to prepare and interpret budgets. * Ability to learn and use current pricing models (i.e. QIP). * Demonstrated Expert knowledge of WordPerfect, Word for Windows, Excel, and windows based e-mail systems preferred. * Must possess superior editing skills.2012-01-13 09:04:24United StatesQuintilesGeorgia1117832GAMarietta, GA25879242http://quintiles.jobs/xml/25879242/jobUSARaleighTitle: *Data Team Lead / Assoc Data Team Lead - Raleigh, NC- Homebased or Officebased Location: USA-North Carolina-Raleigh Other Locations: Home based Opportunities Available! Nationwide! We are seeking enthusiastic Data Team Leads/ Assoc Data Team Leads to join our team. PURPOSE Manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. RESPONSIBILITIES Client Management: * Serve as primary point of contact for customer on data management deliverables * Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise * Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources * Maintain strong customer relationships * Ensure open communications with customer and Quintiles management to manage and meet contractual obligations Service Management: • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders • Support DM service delivery with comprehensive DM process and technical expertise in executing projects • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables • Create and/or review and sign-off on all data management plan (DMP) documents • Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW • Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions • Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organise and drive change across multiple projects/programme (with minimal support) • Ensure timely follow-up and resolution of compliance issues • Serve as Subject Matter Expert (SME) -Provide leadership and expertise in a specific CDM task or technology • Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff • Maintain internal tracking databases and systems Financial Management/Business Development Support: • Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW) • Manage SOW/budget -Review financial reports on a monthly basis and participate in project reviews as requested and Identify out of scope tasks and track change orders to completion • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing • Participate in and support RFP process (review RFP documents, pricing, attend bid defense) Other: * Independently bring solutions to the CDM team/CDM department * Lead and/or participate in a focus team or global or local best practice team * Communicate lessons learned and/or present in CDM workshop(s) * Participate in the development and implementation of new technology or tool * Present at professional conferences and/or publish articles in professional journals * Provide review and input on developing, revising, and maintaining core operating procedures and work instructions * Perform other duties as directed by the functional manager * Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 8 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience * Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes) * Demonstrated expert data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology) * Previous experience of handling customer negotiations * Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology * Knowledge of operating procedures and work instructions and the ability to apply them in practice * Knowledge of Good Clinical Practices and relevant regulatory guidelines * Excellent communication, interpersonal, customer service, and teamwork skills * Excellent project management skills * Excellent organizational and problem-solving skills * Ability to work independently with available resources, e.g., functional managers, senior DTLs * Comprehensive understanding of clinical drug development process * Ability to establish and maintain effective working relationships with coworkers, managers and customers * Occasional travel is required2012-01-06 07:51:29United StatesQuintilesNorth Carolina1201169NCRaleigh, NC25732106http://quintiles.jobs/xml/25732106/jobUSASan DiegoTitle: *Data Team Lead / Assoc Data Team Lead - Homebased Location: USA-California-San Diego Other Locations: United States Home based Opportunities Available! Nationwide! We are seeking enthusiastic Data Team Leads/ Assoc Data Team Leads to join our team. Position can be homebased anywhere in the United States. PURPOSE Manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents. RESPONSIBILITIES Client Management: * Serve as primary point of contact for customer on data management deliverables * Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise * Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources * Maintain strong customer relationships * Ensure open communications with customer and Quintiles management to manage and meet contractual obligations Service Management: • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders • Support DM service delivery with comprehensive DM process and technical expertise in executing projects • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables • Create and/or review and sign-off on all data management plan (DMP) documents • Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW • Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions • Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organise and drive change across multiple projects/programme (with minimal support) • Ensure timely follow-up and resolution of compliance issues • Serve as Subject Matter Expert (SME) -Provide leadership and expertise in a specific CDM task or technology • Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff • Maintain internal tracking databases and systems Financial Management/Business Development Support: • Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW) • Manage SOW/budget -Review financial reports on a monthly basis and participate in project reviews as requested and Identify out of scope tasks and track change orders to completion • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing • Participate in and support RFP process (review RFP documents, pricing, attend bid defense) Other: * Independently bring solutions to the CDM team/CDM department * Lead and/or participate in a focus team or global or local best practice team * Communicate lessons learned and/or present in CDM workshop(s) * Participate in the development and implementation of new technology or tool * Present at professional conferences and/or publish articles in professional journals * Provide review and input on developing, revising, and maintaining core operating procedures and work instructions * Perform other duties as directed by the functional manager * Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 8 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience * Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes) * Demonstrated expert data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology) * Previous experience of handling customer negotiations * Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology * Knowledge of operating procedures and work instructions and the ability to apply them in practice * Knowledge of Good Clinical Practices and relevant regulatory guidelines * Excellent communication, interpersonal, customer service, and teamwork skills * Excellent project management skills * Excellent organizational and problem-solving skills * Ability to work independently with available resources, e.g., functional managers, senior DTLs * Comprehensive understanding of clinical drug development process * Ability to establish and maintain effective working relationships with coworkers, managers and customers * Occasional travel is required2012-01-06 07:51:20United StatesQuintilesCalifornia1201155CASan Diego, CA25732090http://quintiles.jobs/xml/25732090/jobUSAMariettaTitle: *Lab Project Services Manager / Assoc Lab Project Services Manager Location: USA-Georgia-Marietta Other Locations: Quintiles has a rewarding opportunity for a Lab Project Services Manager in our Marietta, GA office. Position can be filled at a Grade 31 Lab Project Services Manager level or Grade 30 Assoc Lab Project Services Manager level. PURPOSE Under general direction, manage all laboratory aspects of clinical trial projects for a client, either global and or regional studies; serve as a point of escalation for project level issues, while ensuring consistency of delivery on a global level; and participate in business development process consistent as required. RESPONSIBILITIES * Perform project management of laboratory aspect of assigned studies. * Develop start-up plans including but not limited to project monitoring and communication plan including tracking of milestones and timelines, risk management and action logs. * Lead problem solving and resolution efforts in a timely, customer focused manner. * Establish self as key client relationship contact, including tasks such as coordinating client surveys and follow up actions, making periodic "health check" calls, and identifying any potential issues to the relevant mangers * Participate in proposal development process, as well as, lead bid defense presentations in partnership with Business Development and Senior Project Services/Operational Client Lead staff. * Perform the technical review at project initiation and provide input into project proposals as well as lead discussions around budget implications and changes. * Provide scientific and technical advice to ensure delivery to the customer's satisfaction, on time and within budget. * Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. * Lead in the identification and resolution of service level issues, as well as the proactive development of contingency plans to mitigate laboratory risk. * Ensure lessons learned are considered, shared and improvements included in study design process. * Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each assigned protocol. * As required, prepare and present study-specific materials and services at Investigator, Kick-off and Bid Defense meetings. Provide additional training to sponsor, CRO, and site personnel as required (telephone training, attendance at CRA training meetings, site refresher meetings, etc.). Participate in external and internal audits as required. * Provide day to day guidance to more junior staff as required; may act as a mentor as well as assist in the training and development of more junior staff. * Direct, mentor and assist in training of less experienced Project Services staff. Mentoring may include staff assigned to manage projects for the specific client or within the program. * Bachelor's degree in science related field and minimum 3-5 years of clinical or research industry experience, including 1 year project management experience; or equivalent combination of education, training and experience * Possess strong interpersonal skills for interaction with senior members within sponsor organizations and demonstrated ability to meet deadlines. * Experience in successfully leading Phase I-IV clinical trials. * Demonstrated technical and therapeutic expertise, in addition to significant experience with key customers. * Demonstrated computer proficiency with Microsoft Office and Quintiles LIMS system. . * Possess an understanding of medical and clinical research terminology. * Demonstrated ability to work in a fast-paced, high stress environment. * Knowledge of Project Management processes and terminology. * Previous knowledge of Quintiles Laboratories processes and computer systems is highly desired. * Good organizational and operational skills * Good accuracy and attention to detail skills * Strong written and verbal communication skills including good command of English language PHYSICAL REQUIREMENTS * Extensive use of telephone and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time * May require occasional travel2012-01-01 19:28:31United StatesQuintilesGeorgia1118105GAMarietta, GA25652788http://quintiles.jobs/xml/25652788/jobUSAResearch Triangle ParkTitle: Drug Safety and Endpoint Associate (Assoc CEVA Mgr) Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Provides project leadership and accountability for regional/global safety/endpoint studies. Applied knowledge in drug safety and/or endpoint studies. Accountable for project and team management and service delivery of medium to large sized regional and global safety /endpoint projects. Provide leadership and accountability for customer-facing activities and operational service delivery. RESPONSIBILITIES · Manage customer relationships, deliverables, expectations, and communication for assigned safety/endpoint studies. Day-to-day customer-facing leadership at project level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management. · Provide leadership and structure for customer service through proposal generation, bid defense to project delivery. · Provide leadership for Lifecycle Safety project teams: keep local/global ILS team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status · Serve as primary point of contact within Lifecycle Safety for all internal and external customers. · Collaborate with other Lifecycle Safety Managers and assigned team members to proactively address and resolve customer needs and issues · Manage realization/profitability for assigned projects/programs. · Participate in client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans (CAPs). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Working knowledge of Lifecycle Safety service lines including Serious Adverse Event processing and/or endpoint processing · In knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Effective team management and leadership skills, conflict management. · Strong project management skills especially in planning, team collaboration/building, and organizational skills. · Effective verbal and written communication skills including ability to network and lead teleconferences. · Ability to work on multiple projects and manage competing priorities. · Proven strong presentation; report writing skills and customer focus skills. · Effective judgment, negotiating, decision-making, and problem solving skills. · Creative and innovative, initiative and pro-active. · Ability to establish and maintain effective working relationships with coworkers, managers and customers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree or educational equivalent in health science or other directly related field and 5 years' clinical research experience in a Contract Research Organization or Pharmaceutical company or equivalent combination of education, training or experience. Strong preference for endpoint/DSMB/and or adjudication committee experience. PHYSICAL REQUIREMENTS · Extensive use of keyboard requiring repetitive motion of fingers. · Extensive use of telephone and face-to-face communication requiring accurate perception of speech. · Regular sitting for extended periods of time. · Requires frequent domestic and occasional international travel.2011-12-27 11:33:11United StatesQuintilesNorth Carolina1117252NCResearch Triangle Park, NC25562924http://quintiles.jobs/xml/25562924/jobUSAMariettaTitle: Manager, Contracts Location: USA-Georgia-Marietta Other Locations: ** This position is based in Atlanta/Marietta office** PURPOSE Line Management responsibilities for a Contracts/Proposal team, leading and managing the day to day contract/proposal development process RESPONSIBILITIES •Manage staff in accordance with organization's policies and applicable legislation. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration •Responsible for performance of direct reports, overseeing the contract development process and ensuring consistency across all respective deliverables •Develop and negotiate agreements to maximize profit on each contract and drive the contracting process to ensure timely revenue recognition •Participate in the selection and on-boarding process for new Contracts staff by conducting candidate review and participating in the interview process. Ensure staff have the appropriate materials, systems access and training to complete job responsibilities •May take a proactive role in developing long standing relationships with preferred Quintiles customers, and may take a leadership role in bid defence strategy and planning, as appropriate •Act as primary interface for customers and provide expert input on delivery of all Contracting services required by assigned customers •Improve proposal, budgeting and contracting standards. May participate in quality or process improvement initiatives •Negotiate contractual documents, in consultation with Legal and/or Finance, as required •Create budgets, scopes and contracts as required and review difficult contracting situations •Provide advice, support and guidance as needed and serve as a mentor to colleagues •Perform other duties as assigned All responsibilities are essential job functions unless noted as nonessential (N). Knowledge of CRO Industry •Excellent knowledge of Microsoft Excel and Word and understanding of costing models •Excellent knowledge of contract and budget preparation and ability to interpret budgets •Ability to interpret RFPs to gather top information and major cost drivers and ability to interpret protocols •Possess strong analytical skills and excellent verbal and written communication skills •Ability to manipulate costing model to build budgets for studies and link costing model to customer bid grids •Ability to interpret protocols to gather information for budget and contract development •Ability to establish and maintain effective working relationships with coworkers, managers and customers MINIMUM REQUIRED EDUCATION AND EXPERIENCE •Degree in Life Science, Business Management or related field and a minimum of 7 year's direct experience in Contracts, Finance, Proposals, industry specific operations experience with previous line management experience; or equivalent combination of education, training and experience2011-12-26 11:34:02United StatesQuintilesGeorgia1117833GAMarietta, GA25553850http://quintiles.jobs/xml/25553850/jobUSANoneTitle: *Clinical Project Manager / Sr. Clinical Project Manager - Infectious Disease & Respiratory Location: United States Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE We are recruiting for a Clinical Project Manager specializing in Infectious Disease & Respiratory studies within our Clinical Project Management Departmentto manage the execution of medium to large multi regionally-based clinical studies, from initiation through to closeout. This role is responsible for ensuring that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies and practices. RESPONSIBILITIES * Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects. * Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance. * Serve as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to. * Report on team performance against contract, customer expectations, and project baselines to management. * Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk. * Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties. * Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. * Provide input for the development of proposals for new work and project budgets. * Provide input to line managers of their project team members' performance relative to project tasks. Recommend team members' further professional development. Support staff development. Mentor less experienced CPMs. * Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of CRA team. * Prepare and present project information at internal and external meetings. * Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff. * Define project workloads and assignments. Develop and oversee maintenance of internal databases and project plans MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree in life sciences or related field and extensive clinical research experience including project management experience and experience in clinical operations; or equivalent combination of education, training and experience. * Project Management experience within Infectious Disease or Respiratory, is required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines * In depth therapeutic and protocol knowledge * Strong communication and interpersonal skills, including good command of English language * Strong organizational and problem solving skills * Demonstrated ability to deliver results to the appropriate quality and timeline metrics * Good team leadership skills * Effective mentoring and training skills * Excellent customer service skills * Good judgment * Effective presentation skills * Ability to manage competing priorities * Strong software and computer skills, including MS Office applications * Ability to establish and maintain effective working relationships with coworkers, managers and clients.2011-12-22 11:39:19United StatesQuintilesNone1114367NoneVirtual, USA25519064http://quintiles.jobs/xml/25519064/jobUSANoneTitle: EXPERIENCED Oncology CRAs Needed - Nationwide Location: United States Other Locations: Calling all experienced CRAs! The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas. In fact, Quintiles conducts more clinical trials than anyone else in the world. Become involved in work that improves the quality of life for people around the globe. Let your career soar! We are seeking enthusiastic and experienced CRAs to join our team. The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. Review regulatory documents as required and prepare site visit reports. Responsible for multiple projects and must work both independently and in a team environment. May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed. - BS/BA degree is mandatory. - 2 years of Clinical MONITORING experience required - Must have at least 2 years of solid tumor or leukemia/hematology experience - Customer service orientation. - Sound knowledge of medical terminology and clinical monitoring process. - In depth therapeutic and protocol knowledge as provided in company training. - Ability to perform regionalized travel an average of 65%, depending on project needs. - Excellent verbal and written communications skills. - In depth therapeutic and protocol knowledge as provided in company training. - Excellent interpersonal and organizational skills and attention to detail. - Computer literacy, proficiency in MS Office.2011-12-15 09:17:24United StatesQuintilesNone1114615NoneVirtual, USA25372503http://quintiles.jobs/xml/25372503/jobUSAHawthorneTitle: Recruitment Director- Quintiles Consulting, based New York Location: USA-New York-Hawthorne Other Locations: USA-New Jersey-Parsippany, USA-New York-New York City The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights.Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Quintiles Consulting is seeking a Director of Staffing (or Associate Director) to undertake recruitment for the Global Consulting organization. This role is located in Hawthorne, NY. Candidates should have experience of recruiting in Management Consultancy, and have a successful track record in sourcing and delivering search projects. Specific responsibilities will include: * Provide continuous improvement of the staffing function through the development and implementation of all staffing programs within Global Consulting * This includes, Early Talent, Experienced Hires, and Executive Recruitment * Manage a staffing team through direct line or matrix reporting structure * Develop and manage executive reports and dashboards for leadership team * Manage functional staffing budget and vendors * Develop and implement cutting edge recruitment programs to attract qualified candidates and continually replenish the candidate pipeline based upon market conditions * Consult with leadership to develop staffing plan and talent demand forecasts for all global regions * Provide management coaching and counseling to leadership team to effectively align strategic staffing goals to business needs * Keep abreast of market trends and demand impacting the company's ability to attract competitive candidates * Support activities and initiatives associated with change management, mergers and acquisitions * Partner closely with Human Resources Business Partners, Compensation, Finance, Global Programs and Metrics office, and other support functions * Other responsibilities as assigned and related to the Global Staffing Team, Human Resources, and Global Consulting REQUIRED KNOWLEDGE, SKILLS AND ABILITIES * Extensive experience in full life cycle recruitment in life sciences consulting strongly preferred * Must have ability to run early talent through executive search programs * Working knowledge of recruitment metrics and KPI's * Ability to partner with Executives in fast paced environment * Proven experience in partnering with other support functions * Proven ability to create processes, metrics, and delivery both independently and in collaborative environment MINIMUM REQUIRED EDUCATION AND EXPERIENCE * Bachelor's degree or educational equivalent and 8 years of experience within a staffing function as a recruiter or combination of recruiter and specialist experience including 2 years direct line management experience and experience operating with senior/executive management teams; or equivalent combination of education, training and experience.2011-12-12 11:59:34United StatesQuintilesNew York1117442NYHawthorne, NY25293470http://quintiles.jobs/xml/25293470/jobUSACambridgeTitle: Technical Project Manager -- Outcome Location: USA-Massachusetts-Cambridge Other Locations: **Preferable location is Cambridge, MA** Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose:With limited oversight from management, the role is to implement agreed upon strategies for the management of national and international (US/EU/ROW) internet-based outcomes studies with pre-specified timelines and budgets at the project and/or Program level. Primary Responsibilities: * Leads Project, Programs or initiatives that may include monitoring, EDC development (production and maintenance), data management, programming, safety, statistics, report/protocol writing, medical affairs and agency presentations and ensure these requirements are properly documented. * Manages global project goals within Clinical Operations including startup activities focused around site identification, patient recruitment, contract (CTA) and budget, enrollment and monitoring plans, marketing and public relations campaigns as they align to the expectations for the study to adhere to the complex project requirements, deliverables, schedules and budgets. * Within a matrix environment, oversee all deliverables, milestones and deadlines related to assigned studies/projects, including site enrollment, regulatory and IRB/EC approvals, and patient enrollment and follow-up. * Provide the Clinical Site Management team with the information and tools needed to ensure their ability to support the program both initially and throughout the project duration. * Work closely with the cross functional teams (such as Development, Quality Control, Data Management, Statistics) to lead resources during the design, development, testing and implementation of EDC, including answering questions and clarifying requirements for the clinical design and objectives. * Act as customer advocate throughout the project lifecycle. * Serve as the liaison between the clients and internal team to ensure project-specific information and ongoing updates are proactively communicated. Assure that meeting minutes and communication of decisions and action items are documented appropriately in minutes. * Firm understanding the contractual obligations to each client and ensure those responsibilities are met (with the goal to exceed those expectations). Leads the development and review of the proposal and budget to align with the SOW. * Implement client’s expectations for the study and define project requirements, deliverables, schedules and budgets. * Identify out-of-scope tasks and client requests per change management and facilitate writing Change Orders that align with Sponsor expectations. * Provides monthly status reports to sponsor and/or internal purposes, financial reports requirements utilizing corporate reporting tools (PSR Meetings), Invoice Generation and revenue review (ETC and Project Margin), Timesheet review, and pass-through cost review as applicable. * Guide client through EDC configuration and customization decisions including driving the software features versus cost/schedule trade-off decisions with the client and offer best practices. Ability to understand and offer customization options that align with the technical group's capabilities. This includes managing internal resourcing ageist client timelines and user requirements. * Proactively identify issues and develop strategies for assuring study timelines are met and assuring quality deliverables. This includes risk management, contingency planning, enrollment strategies and creative "outside the box" thinking. * Develop, Review and/or maintain clear study related documents, including supporting system specifications that require technical writing. Ensures all critical study documentation (i.e., DMP, Monitoring Plan, SAP, and Training) is collected and filed in TMF/eTMF so that we are audit ready. * Manage the preparation, maintenance and traceability of central and site files (TMF/eTMF) for projects with the functional leads. * Adhere to internal change management processes per our internal SOPs, WI and project specific process. Including project specific quality initials to assure that projects are audit ready. * Identification, coordination and management of external providers/vendors as applicable. * Participate in the development, review and drafting of proposals and then participate in the bid defense meetings as required. * Mentor and/or manage project management staff and other team members as applicable. * This job description may include additional individual duties and responsibilities not listed in detail but still expected to be reasonably performed. Requirements: * Master's degree or a Bachelor's degree and equivalent experience. * 6 or more years of Project Management experience preferably in the health care, medical research, CRO, Pharmaceutical or technology setting. * In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and understanding of the clinical development process (Phase I-IV, post marketing, abstraction protocols and/or REMS). * The ability to learn quickly, multi-task and prioritize are essential including the ability to handle multiple projects simultaneously and manage multi-functional teams. * Must have creative problem solving skills; very strong written, verbal communication skills. * Demonstrated success in Project Management. * Ability to travel and attend international meetings.2011-12-09 10:33:40United StatesQuintilesMassachusetts1116762MACambridge, MA25267988http://quintiles.jobs/xml/25267988/jobUSACambridgeTitle: Systems Administrator--Outcome Location: USA-Massachusetts-Cambridge Other Locations: Outcome, the real-world and late phase research company of Quintiles, is the global market leader in patient registries, peri and post-approval studies, data, and integrated technologies for evaluating real-world outcomes. We provide services and technologies focused on evaluating the safety, effectiveness, value, and quality of healthcare products, therapies, and services. Our teams have designed and implemented an industry-leading number of real-world studies including many of the largest and most well-recognized programs for disease outcomes, safety, and risk management. Purpose:The System Administrator is responsible for deploying and maintaining the infrastructure used to serve Outcome’s hosted healthcare application solutions to our global clients. This position supports a 24x7 SaaS organization maintaining Production, Test and Development servers and supporting infrastructure. Technologies supported are Linux, J2EE Servers, Oracle Servers, Enterprise Storage infrastructure as well as the network environments. Primary Responsibilities: Provide 24x7 production environment monitoring and support. Manage and maintain existing computer systems hardware to minimize downtime and maintain a high level of availability. Install, configure and integrate new computer systems hardware into the existing environment to meet customer requirements. Configure, manage and maintain enterprise storage systems (NetApp, EMC) Maintain and augment automated monitoring of mission-critical systems. Maintain and improve access controls to all production computer systems. Manage backup of mission-critical code and databases. Conduct and follow all change management processes to support Outcome’s SaaS systems. Maintain and support Outcome’s virtualization environment with technologies like, SRM, vMotion, DRS, and vStorage Lead and manage complex technical projects with cross functional teams members. Work with software and database engineers to diagnose performance-related issues. Document configuration changes, as well as processes and procedures, as required to satisfy external auditors and clients. Interact with external data center staff on computer systems and network-related installation, configuration and trouble-shooting. Build backend systems to support Outcome’s environment such as , Kickstart, Puppet, SVN, etc… Act as backup to other members of the Production Service team. Requirements: BS in Computer Science or relevant major 7 years experience with RedHat/Fedora/Centos Linux in an enterprise environment Solid Eexperince with at least four of the following technologies: Apache, Tomcat, Oracle RDBMS, EMC Storage Area Networks, JBOSS, and VMWare. Solid experience supporting and maintaining EMC Storage Area Network’s. Ability to write/maintain shell and perl scripts Solid experience with configuration management and backend tools like Puppet and kickstart. Strong attention to detail, communication skills (both verbal and written) Experienced with Quality Management methods and philosophies Ability to write/maintain shell and Perl scripts Strong attention to detail, communication skills (both verbal and written) Experienced with Quality Management methods and philosophies Experience with any of the following a plus: NetAPP; Cisco router and firewall configuration and maintenance; Gmail; Cisco Call Manager.2011-12-09 10:33:06United StatesQuintilesMassachusetts1116744MACambridge, MA25267980http://quintiles.jobs/xml/25267980/jobUSAOverland ParkTitle: *Statistical Programmer 2 - Overland Park, KS Location: USA-Kansas-Overland Park Other Locations: United States Quintiles is seeking an enthusiastic Statistical Programmer 2 to join our U.S. Biostatistics Operations team in Overland Park, KS. The Statistical Programmer will provide advanced technical expertise as part of the Statistical Programming (SP) team to develop and maintain programs to meet internal and external clients' needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. RESPONSIBILITIES • Program, plan and co-ordinate: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks. • Program the integration of databases from multiple studies or sources. • Develop and plan programming documentation including plans and specifications, as appropriate. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and the Statistical Programming department. • Perform and plan the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of Lead for single studies, under supervision. • Manage project budget and resource requirements. • Provide training and guidance to lower level and new staff. • Masters degree or educational equivalent in computer science or related field and 1 year relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 2 years relevant experience; or equivalent combination of education, training and experience • Knowledge of statistics and/or clinical drug development process • Knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities.2011-12-08 13:17:19United StatesQuintilesKansas1117039KSOverland Park, KS25248101http://quintiles.jobs/xml/25248101/jobUSAOverland ParkTitle: Clinical Research Associate/ Sr CRA (Cardiology/ medical device) ~ Location: USA-Kansas-Overland Park Other Locations: Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. PURPOSE Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. RESPONSIBILITIES Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. Act as a mentor for clinical staff including conducting co-monitoring and training visits. May provide assistance to the CTL with design of study tools, documents and processes. Location: QOPK, regional home-based possible provided exceptional experience Therapeutic requirements: Cardiology and medical device experience preferred. Experience requirements: Minimum 2-4 years experience in clinical/scientific research, or medical device/pharmaceutical trial experience. Bachelors Degree in Science or Healthcare Related Field required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines In depth therapeutic and protocol knowledge as provided in company training Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer Strong written and verbal communication skills including good command of English language Excellent organizational and problem-solving skills Effective time management skills Ability to manage competing priorities Effective mentoring and training skills Ability to establish and maintain effective working relationships with coworkers, managers and clients MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor's degree in a health care or other scientific discipline and 2 years of on-site monitoring experience2011-11-15 09:41:16United StatesQuintilesKansas1115852KSOverland Park, KS24872819http://quintiles.jobs/xml/24872819/jobUSAResearch Triangle ParkTitle: Drug Safety and Endpoint Associate Location: USA-North Carolina-Research Triangle Park Other Locations: PURPOSE Provides project leadership and accountability for regional/global safety/endpoint studies. Applied knowledge in drug safety and/or endpoint studies. Accountable for project and team management and service delivery of medium to large sized regional and global safety /endpoint projects. Provide leadership and accountability for customer-facing activities and operational service delivery. RESPONSIBILITIES · Manage customer relationships, deliverables, expectations, and communication for assigned safety/endpoint studies. Day-to-day customer-facing leadership at project level. Responsibilities include project planning (timelines, deliverables), scope management, quality management and project financial management. · Provide leadership and structure for customer service through proposal generation, bid defense to project delivery. · Provide leadership for Lifecycle Safety project teams: keep local/global ILS team current on project developments; lead internal Lifecycle Safety team meetings to review project processes and status · Serve as primary point of contact within Lifecycle Safety for all internal and external customers. · Collaborate with other Lifecycle Safety Managers and assigned team members to proactively address and resolve customer needs and issues · Manage realization/profitability for assigned projects/programs. · Participate in client and internal audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of Corrective Action Plans (CAPs). REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Working knowledge of Lifecycle Safety service lines including Serious Adverse Event processing and/or endpoint processing · In knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Effective team management and leadership skills, conflict management. · Strong project management skills especially in planning, team collaboration/building, and organizational skills. · Effective verbal and written communication skills including ability to network and lead teleconferences. · Ability to work on multiple projects and manage competing priorities. · Proven strong presentation; report writing skills and customer focus skills. · Effective judgment, negotiating, decision-making, and problem solving skills. · Creative and innovative, initiative and pro-active. · Ability to establish and maintain effective working relationships with coworkers, managers and customers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's degree or educational equivalent in health science or other directly related field and 5 years' clinical research experience in a Contract Research Organization or Pharmaceutical company including at least 3 years' of Lifecycle Safety experience(SAE processing/SUSAR regulatory reporting/endpoint/DSMB/and or adjudication committees. or equivalent combination of education, training or experience. PHYSICAL REQUIREMENTS · Extensive use of keyboard requiring repetitive motion of fingers. · Extensive use of telephone and face-to-face communication requiring accurate perception of speech. · Regular sitting for extended periods of time. · Requires frequent domestic and occasional international travel.2011-10-31 14:58:17United StatesQuintilesNorth Carolina1115216NCResearch Triangle Park, NC24498605http://quintiles.jobs/xml/24498605/jobUSARaleighTitle: *Statistical Programmer 2 - Raleigh, NC Location: USA-North Carolina-Raleigh Other Locations: Quintiles is seeking an enthusiastic Statistical Programmer 2 to join our U.S. Biostatistics Operations team in our Raleigh, NC office. The Statistical Programmer will provide advanced technical expertise as part of the Statistical Programming (SP) team to develop and maintain programs to meet internal and external clients' needs. Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. Provide technical expertise to the Statistical Programming department. RESPONSIBILITIES • Program, plan and co-ordinate: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables and listing summaries, (ii) the programming of analysis databases (derived datasets) and transfers of data for internal and external clients and (iii) the programming of database quality control checks. • Program the integration of databases from multiple studies or sources. • Develop and plan programming documentation including plans and specifications, as appropriate. • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and the Statistical Programming department. • Perform and plan the development, implementation and validation of new process technologies, macros and applications. • Fulfill project responsibilities at the level of Lead for single studies, under supervision. • Manage project budget and resource requirements. • Provide training and guidance to lower level and new staff. • Masters degree or educational equivalent in computer science or related field and 1 year relevant experience; Bachelor's degree or educational equivalent in computer science or related field and 2 years relevant experience; or equivalent combination of education, training and experience • Knowledge of statistics and/or clinical drug development process • Knowledge of statistical computing applications such as Base SAS, SAS/STAT and SAS Macro Language • Good organizational, interpersonal, leadership, communication skills and multi-tasking abilities.2011-10-17 10:50:22United StatesQuintilesNorth Carolina1114546NCRaleigh, NC24258592http://quintiles.jobs/xml/24258592/jobUSAAshevilleTitle: Cardiology Specialty Sales Representative - Asheville, NC/Greenville, SC 6594 Location: USA-North Carolina-Asheville Other Locations: USA-South Carolina-Greenville As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2011-10-05 10:02:10United StatesQuintilesNorth Carolina1114050NCAsheville, NC24051443http://quintiles.jobs/xml/24051443/jobUSAHuntsvilleTitle: Cardiology Specialty Sales Representative - Birmingham N/Huntsville/UAB, AL 6594 Location: USA-Alabama-Huntsville Other Locations: As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for a Cardiology Specialty Sales Representatives to join our team of over 10,000 global field representatives in several regions making over 20 million product details annually for our pharmaceutical and biotech clients. In this role, you will be supporting Janssen Pharmaceuticals, Inc., a member of the Pharmaceutical Companies of Johnson & Johnson, fully dedicated to serving the needs of health care providers and their patients. Specialty Sales Representative - Cardiology The primary objective of the sale representative is to meet established sales goals by delivering real value to our customers through differentiated products and services. The sales representative will be supported in this initiative with tools and promotional resources designed to have local impact. The successful representative will demonstrate the ability to target and manage their territory strategically while operating within an assigned budget. They will also need to be a highly engaged, positive team player and show a high degree of customer focus. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · 4 year Bachelor's degree from an accredited University required · 3 or more years of direct selling experience to healthcare professionals in the pharmaceutical, biotech, device or healthcare industry, or large account management experience is required . · 1 or more years experience selling cardiology products to Cardiologists is preferred . · Strong scientific/clinical acumen required · Proven track record of success in a high science, competitive selling environment · Documented sales results, including examples of company awards, or participation in management development program are preferred. · Strong verbal, interpersonal and listening skills · Ability to travel overnight as required · Residence within the current geography or willingness to relocate to the current geography is required. Competencies · Ability to handle ambiguity while driving results · Demonstrated performance and results · Demonstrated customer and marketplace expertise · Ability to effectively discuss risk/benefits with targeted healthcare providers · Ability to effectively build successful territory business plans to ensure successful product launches. · Professional credibility; demonstrated success in persuasion, influence and negotiation skills · Business Insight; demonstrated ability to learn and apply highly technical/scientific knowledge · Proficient with the selling process · Initiative & execution-oriented · Collaboration; Customer Focused with ability to identify, develop and leverage relationships · Team player2011-10-05 10:02:06United StatesQuintilesAlabama1114038ALHuntsville, AL24051428http://quintiles.jobs/xml/24051428/jobUSALos AngelesTitle: Clinical Educator, Oncology/Infusion Specialty - Greater Los Angeles Area - 4425 Location: USA-California-Los Angeles Other Locations: USA-California-Irvine, USA-California-Long Beach, USA-California-Santa Monica, USA-California-Hollywood, USA-California-Bakersfield, USA-California-Anaheim, USA-California-Santa Barbara, USA-California-San Bernardino, USA-California-Beverly Hills As the only global provider of commercial solutions, Quintiles understands what it takes to deliver nationally and internationally. Our teams help biopharma get their medicines to the people who need them. We help customers gain insight and access to their markets and ultimately demonstrate their product's value to payers, physicians and patients. A significant part of our business is acting as the biopharma's sales force to physicians or providing nurses to educate patients or prescribers. With the right experience, you can help deliver medical breakthroughs in the real world. We are excited to announce that at this time we are looking for ClinicalEducatorswith experience in oncology and/or hematology and/or infusion to join our team of over 10,000 global field representatives in several regions for our pharmaceutical and biotech clients. In this role you will be supporting a major pharmaceutical company by educating peers on a product utilized in the hematology/oncology disease state. Clinical Educator - Oncology/Infusion Specialty The Clinical Educator - Oncology/Infusion Specialty provides education to their peers in transfusion centers to gain a better understanding of patients at risk for chronic iron overload and implementation of processes to identify patients at risk. Education is also presented to help staff have a better understanding of disease state treatments and proper dosing and administration of these treatments. This education is provided through formal presentation, round table discussion and individual interactions. This is a field based employee. Quintiles offers a friendly, progressive work atmosphere and a comprehensive benefits package including medical, dental, life insurance and vision coverage, tuition assistance, bonus plan and 401(k). We look forward to the prospect of working with you! Please apply on-line at:www.quintiles.com EOE Qualifications/Experience · RN with a 4 year Bachelor's degree required, masters degree preferred · Oncology and/or Hematology and/or Infusion Nurse specialist with health educator experience required · Oncology Certified Nurse preferred · Current license in good standing · Minimum of 3-5 years of Hematology/Oncology clinical experience · Transfusion experience required; blood bank experience may be considered with clinical background · Excellent teaching skills · Strong interpersonal skills, with demonstrated effectiveness working independently and on cross-functional teams · Excellent organizational skills · Experience in delivering service solutions desirable · Ability to manage multiple tasks · Willingness to travel · Excellent written and oral skills · Excellent presentation skills · Enthusiastic, good attitude, and ability to motivate others2011-09-01 08:16:27United StatesQuintilesCalifornia1112416CALos Angeles, CA23374771http://quintiles.jobs/xml/23374771/jobUSANew York CityTitle: Senior Director, Consulting Location: USA-New York-New York City Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Our team of consultants is comprised of individuals with a blend of multidimensional industry and operational expertise combined with business, process, and technology strategy experience. The result of our work is real-world data, fresh insights and actionable business, portfolio and product strategies to improve your bottom line and marketplace success. If you are seeking an opportunity to work with an established Global Industry Leader and enjoy working in the spirit of entrepreneurship, Quintiles Consulting could be the place for you. Specific responsibilities may include: * * Define, develop and implement strategic plans/offerings in applicable area (new service offering) * Design and lead client engagements and oversee project deliverables including research analysis plans, progress, reports, presentations, abstracts, surveys, discussion guides, manuscripts and product dossiers. * Taking a new service offering into the marketplace and developing the customer base (Business Development) * Developing and hiring staff needed for delivery of engagements * Management of staff * Engagement Management * Thought leadership * Practice Leadership * Lead continuous improvement of departmental processes and procedures * Publish research in peer reviewed journals and present at industry specific events * Direct and manage a consulting team for assigned region, through a direct line matrix reporting structure * BS degree, advanced degree preferred * 15 years in Biopharmacutical industry * 10 years in Life Sciences Consulting, with at least 6 years in a leadership role or equivalent combination of the above * Deep expertise in the development of strategy, technology and process innovations for scientific discovery and development areas of the biopharmaceutical industry. * Strong business and analytical skills with an emphasis on strategic and financial analysis in the life sciences industry2011-08-22 08:29:32United StatesQuintilesNew York1112073NYNew York City, NY23156364http://quintiles.jobs/xml/23156364/jobUSAResearch Triangle ParkTitle: (ITLS) Drug Safety IT Business Analyst Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta Quintiles Information Technology Unit is completing the implementation of a global adverse event processing and analysis platform. This platform has been designed to support operations and services for more than 50 clients worldwide with access by several hundred lifecycle safety associates and management located on 4 continents. As adoption of the platform increases, our Global IT team will expand to support platform enhancements, operations for internal Quintiles resources, as well as, many collaboration partners accessing the platform from outside. We are seeking people with experience in technical areas along with knowledge of drug safety solutions and process to join our team. We are seeking a Business Analysis candidate with at least three years experience of eliciting, analyzing, documenting and managing requirements for IT systems. The Business Analyst will be working on a initiatives that assist in the implementation and management of a Lifecycle Safety Platform. Candidate should have in depth experience completing business/functional requirements with experience of Use Cases and Agile methodologies being highly desirable. Must be a strategic thinker, results driven, detailed orientated and capable/comfortable of assuming responsibility for analysis assignments in order to work with minimal supervision. This candidate should have experience working with formal development methodologies, be knowledgeable of various business analysis techniques and have experience maintaining requirements following a formal change control process. * * Minimum of three years of Business Analysis experience * Strong communication, organizational, prioritization and leadership skills * Detailed orientated with strong analytical aptitude * Experience in Business Process modeling * Experience in Use Case development * Experience in writing Business and Functional Specifications * Experience with formal development methodologies * Experience with various business analysis elicitation/analysis techniques * Experience using a Requirements Management Tool - Top Team experience advantageous Familiarity with Prototyping/mock ups - Irise experience advantageous * Workshop facilitation experience * Must be able to lead group discussions and be comfortable eliciting requirements from geographically dispersed stakeholders * Should feel comfortable and be adaptable in an environment with shifting priorities Clinical/Pharma industry experience advantageous * Familiarity with Oracle Argus (formally Relsys) or other drug safety and pharmacovigilance software platform * BS degree in Computer Science or related field * Experience with Agile methodology a plus * CBAP certification * Must be able to travel up to 20% * ~2011-05-24 23:52:14United StatesQuintilesNorth Carolina1107577NCResearch Triangle Park, NC21454586http://quintiles.jobs/xml/21454586/jobUSAResearch Triangle ParkTitle: (ITLS) Drug Safety IT Business Analyst Lead Location: USA-North Carolina-Research Triangle Park Other Locations: USA-Georgia-Atlanta Quintiles Information Technology Unit is completing the implementation of a global adverse event processing and analysis platform. This platform has been designed to support operations and services for more than 50 clients worldwide with access by several hundred lifecycle safety associates and management located on 4 continents. As adoption of the platform increases, our Global IT team will expand to support platform enhancements, operations for internal Quintiles resources, as well as, many collaboration partners accessing the platform from outside. We are seeking people with experience in technical areas along with knowledge of drug safety solutions and process to join our team. We are seeking a top Senior Business Analysis candidate with at least five years LEAD experience of eliciting, analyzing, documenting and managing requirements for IT systems. The Sr. Business Analyst will be working on a initiatives that assist in the implementation and management of a Lifecycle Safety Platform. Candidate should have in depth experience completing business/functional requirements with experience of Use Cases and Agile methodologies being highly desirable. Must be a strategic thinker, results driven, detailed orientated and capable/comfortable of assuming responsibility for analysis assignments in order to work with minimal supervision. This candidate should have experience working with formal development methodologies, be knowledgeable of various business analysis techniques and have experience maintaining requirements following a formal change control process. * Minimum of five years of Business Analysis experience, with 2 in a Lead role * Strong communication, organizational, prioritization and leadership skills * Detailed orientated with strong analytical aptitude * Experience in Business Process modeling * Experience in Use Case development * Experience in writing Business and Functional Specifications * Experience with formal development methodologies * Experience with various business analysis elicitation/analysis techniques * Experience using a Requirements Management Tool - Top Team experience advantageous Familiarity with Prototyping/mock ups - Irise experience advantageous * Workshop facilitation experience * Must be able to lead group discussions and be comfortable eliciting requirements from geographically dispersed stakeholders * Should feel comfortable and be adaptable in an environment with shifting priorities. Clinical/Pharma industry experience advantageous * Familiarity with Oracle Argus (formally Relsys) or other drug safety and pharmacovigilance software platform * BS degree in Computer Science or related field * Experience with Agile methodology a plus * CBAP certification * Must be able to travel up to 15%2011-05-24 23:52:14United StatesQuintilesNorth Carolina1107578NCResearch Triangle Park, NC21454587http://quintiles.jobs/xml/21454587/jobUSAResearch Triangle ParkTitle: Business Process Analyst, Strategic Processes and Portfolio Management, Innovation Location: USA-North Carolina-Research Triangle Park Other Locations: Description A career at Quintiles Transnational Corp. puts you at the corporate center of the leading worldwide pharmaceutical services organization. Quintiles Innovation will be creating a virtual, integrative, scalable, knowledge-based, and technology-enabled business model that maximizes portfolio value and patient benefit. If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. Apply now for our role of Business Process Reengineering Analyst based in RTP, NC. This is an office based role with minimal travel. PURPOSE · Reporting to the Director Business Process Management, the Business Process Analyst is responsible for content documentation and development of Innovation business processes and methodologies using Business Process Management technologies under the direction of the Director Business Process Management · The Business Process Analyst will work collaboratively with internal and external stakeholders to obtain expert content which will drive the development of new business process methodologies for Innovation. · RESPONSIBILITIES The Business Process Analyst will be qualified as a BA/ based on prior experience and will perform the following functions as described: Innovation Business Model / Innovation Model of Work (MOW): · Conduct process discovery efforts with key stakeholders and subject matter experts both internal and external to Innovation; identify opportunities for process integration from external collaborators into the Innovation business model or Innovation Model of Work (MOW); provide support for the identification and integration of novel tools and methodology to support the Innovation MOW as discovered. · In collaboration with the Innovation Business Process Team, create detailed maps of the "to-be" processes into the selected Innovation BPM modeling tool, MetaStorm. · Participate in process output review activities with key stakeholders, subject matter experts and the Innovation Business Process Team. · Identify process metrics and key performance indicators to measure quality, cost, and delivery of the process and service. Facilitate SMEs workshops and sessions for generating content for all required changes · · . · Develop Innovation training materials; provide training to Innovation staff as required. · · · Participate and prepare for management and team meetings to support the development and continued refinement of the Innovation MOW at both the Portfolio and Candidate Level to meet Innovation business requirements as needed. Innovation Business Initiatives: · Conduct discovery efforts with key stakeholders and cross functional subject matter experts to develop business process methodologies for approved Innovation and Quintiles Enterprise initiatives as assigned by the Director Business Process Management. · · Mentoring and managing junior staff where appropriate. · Develop training and support programs for process implementations, as needed. · Provide project support for Innovation Product Development Teams as assigned. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES · Six Sigma Green or Black Belt, Design for Six Sigma, Business Process Re-engineering (BPR), Continuous Quality Improvement (CQI), or International Institute of Business Analysts (IIBA) certification preferred. · Pharmaceutical/ CRO Industry experience is desired. · Experience with process modeling tools such as Visio, MetaStorm. · Experience with statistical software for process capability analysis such as Minitab. JMP, or SAS. · Selected incumbent should be able to demonstrate excellent communication, organizational and planning skills. · Able to work well with all levels of staff within an organization. · Able to effectively participate on teams in addition to supporting the organization as an individual contributor. · Excellent communication and interpersonal skills. · Demonstrated ability to deliver results to the appropriate quality and timeline metrics. · Strong software and computer skills, including MS Office applications like MS project. · Excellent customer service skills - Ability to establish and maintain effective working relationships with coworkers, managers and clients. MINIMUM REQUIRED EDUCATION AND EXPERIENCE · Bachelor's or Master's level degree preferred · A minimum of 3 years of experience in process mapping & process improvement. · International experience in culturally diverse environments.2011-05-05 01:39:19United StatesQuintilesNorth Carolina1106690NCResearch Triangle Park, NC21083280http://quintiles.jobs/xml/21083280/jobUSANew York CityTitle: Principal Consultant - Process Optimization Location: USA-New York-New York City Other Locations: USA-New Jersey-Parsippany, USA-Pennsylvania-Philadelphia Quintiles Consulting is a management consulting firm providing data-driven recommendations and advice to make better fact-based strategic business decisions. With practice areas in Product Development and Commercialization, Regulatory and Quality, Market Access, Market Intelligence and Commercial Analytics, Quintiles Consulting offers solutions to clients in the pharmaceutical, biotechnology and healthcare industries. Building on the global strength of our parent company, Quintiles, a leading worldwide pharmaceutical services organization, we possess an unparalleled ability to carry products from development through registration to market success. Quintiles Consulting is currently seeking a Principal Consultant to join our team in our Process Optimization group. Our team of consultants is comprised of individuals with a blend of multidimensional industry and operational expertise combined with business, process, and technology strategy experience. The result of our work is real-world data, fresh insights and actionable business, portfolio and product strategies to improve your bottom line and marketplace success. If you are seeking an opportunity to work with an established Global Industry Leader and enjoy working in the spirit of entrepreneurship, Quintiles Consulting could be the place for you. We are seeking motivated and qualified individuals that wish to contribute to our goal of helping our clients make better strategic business decisions to help them achieve success. Specific responsibilities to the role may include: * Assist in managing client engagements * Assist in Business Development efforts * Design project research, analysis, and reporting techniques * Oversee the development of project research materials including protocols, analysis plans, surveys, discussion guides, and other data collection instruments * Assist in negotiating contracts * Supervise analysis and interpretation of data * Oversee production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, abstracts, manuscripts, and product dossiers * Contribute to proposal writing * Assist in the management the development of staff For the Process Optimization group, we are seeking considerable resources that understand strategy and operations - idea through execution in the R&D space. Below you will find the types of skill sets we are seeking. * Executive Presence * SME (subject matter expertise) in GCP * Strong understanding of R&D and Quality Systems (GLP, GCP, cGMP) * Phase II-III * Big 4 type experience in organization design and process transformation with R&D and Clinical Operations experience * Big 4 type experience with R&D and global harmonization/transformation experience * Experienced with Clinical Quality Systems * Experienced with GCP Regulations & Process Transformation * MD&D Safety Surveillance Strategy & Transformation * Big 4 type experience with strategy and process transformation experience, Medical Device and Safety experience * Medical Device & Safety Experience Sample Engagements May Include: * Business process transformation / reengineering * Market assessment, evaluation and forecasting * Portfolio strategies * Pricing and reimbursement strategy development and support * Health economic evaluations and health technology assessments * Product positioning and development * Risk-Benefit Analysis * Therapeutic and technical support * Scenario planning * Licensing and partnering strategies * Due diligence * Applied epidemiologic investigations * Disease area reviews and modeling * Value dossier development * Quality of Life studies * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * 5 years experience in the biopharmaceutical industry * Must have at least 2 years working in a management consulting firm * Superior analytical, communication, and presentation skills (sample will be required) * Has experience and abilities in the following areas: research and development, discovery, business process re-engineering, clinical development, product development, commercialization of drugs, due diligence, technical writing, and presentation skills * Ability to travel to the client site as necessary2011-04-09 11:31:14United StatesQuintilesNew York1105343NYNew York City, NY20629108http://quintiles.jobs/xml/20629108/jobUSANew York CityTitle: Principal Consultant Location: USA-New York-New York City Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! We are currently seeking a Principal Consultant to join our team. This is a unique role structured for those who are seeking to rapidly advance their career into a Leadership Role through challenge and innovation. The Principal Consultant is expected to manage multiple projects or engagements, execute on deliverables, and take action on Business Development. Those with high energy and enthusiasm, along with an accomplished background in management consulting should consider the following details. Specific responsibilities to the role may include: * Managing client engagements * Manage Business Development responsibilities, including proposal writing and bid defenses * Design project research, analysis, and reporting techniques, as well as, project plans * Oversee the development of project research materials including protocols, analysis plans, surveys, discussion guides, and other data collection instruments * Negotiate contracts * Supervise multiple workstreams * Oversee production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, abstracts, manuscripts, and product dossiers * Manage the development of staff Sample Engagements could include: * Business process transformation reengineering * Market assessment, evaluation and forecasting * Portfolio strategies * Pricing and reimbursement strategy development and support * Health economic evaluations and health technology assessments * Product positioning and development * Risk-Benefit Analysis * Therapeutic and technical support * Scenario planning * Licensing and partnering strategies * Due diligence * Applied epidemiological investigations * Disease area reviews and modeling * Value dossier development * Quality of Life studies * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * 7 years experience in the biopharmaceutical industry, with at least 3 in consulting * Superior analytical, communication, and presentation skills (sample will be required) * Has experience and abilities in the following areas: research and development, discovery, business process re-engineering, clinical development, product development, commercialization of drugs, due diligence, technical writing, and presentation skills * Ability to travel to the client site as necessary2011-03-07 08:05:38United StatesQuintilesNew York1104093NYNew York City, NY19966946http://quintiles.jobs/xml/19966946/jobUSANew York CityTitle: Consulting Analyst Location: USA-New York-New York City Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet. A traditional CRO can't offer this kind of strategic insight; a traditional consulting firm can't draw upon this level of industry experience. Our consultants leverage our unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! Our team of consultants is comprised of individuals with a blend of multidimensional industry and operational expertise combined with business, process, and technology strategy experience. The result of our work is real-world data, fresh insights and actionable business, portfolio and product strategies to improve your bottom line and marketplace success. If you are seeking an opportunity to work with an established Global Industry Leader and enjoy working in the spirit of entrepreneurship, Quintiles Consulting could be the place for you. We are seeking motivated and qualified individuals that wish to contribute to our goal of helping our clients make better strategic business decisions to help them achieve success. Specific responsibilities to the role may include: * Prepare client presentations using advanced computer and analysis skills * Participate in project execution * Team with Engagement Managers regarding the development of project research materials which include: protocols, analysis plans, surveys, discussion guides, and other data collection instruments * Analysis and interpretation of data * Assist with the production of project deliverables including research plans, status reports, interim reports, technical reports, presentations, abstracts, manuscripts, and product dossiers * Contribute to proposal writing * Process Mapping Sample Engagements: * Business process transformation and reengineering * Change Management * Market assessment, evaluation and forecasting * Portfolio strategies * Pricing and reimbursement strategy, development and support * Health economic evaluations and health technology assessments * Product positioning and development * Risk-Benefit analysis * Therapeutic and technical support * Scenario planning * Licensing and partnering strategies * Due diligence * Applied epidemiologic investigations * Disease area reviews and modeling * Value dossier development * Quality of Life studies * Bachelor's degree required * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * Prefer relevant internship or thesis to Consulting, life sciences, or healthcare * Superior analytical, communication, and presentation skills (sample will be required) * Has exposure in at least one of the following areas: research and development, discovery, business process re-engineering, clinical development, product development, commercialization of drugs, due diligence, technical writing, and presentation skills * Ability to travel to the client site as necessary2011-03-01 07:47:05United StatesQuintilesNew York1102283NYNew York City, NY19868810http://quintiles.jobs/xml/19868810/jobUSANew York CityTitle: Business Intelligence/Data Integration Principal Consultant - IT Strategy & Implementation Team Location: USA-New York-New York City Other Locations: The New Health is a complex and challenging landscape. Quintiles has thrived by constantly reinventing itself, sometimes even reinventing the industry. Our consulting team draws on that experience and decades of analysis to help customers develop products, bring them to market successfully, maneuver through regulatory minefields and even streamline their internal processes. It requires thinking across traditional boundaries in the unique space where insight and execution meet. It requires people who are creative, practical and willing to challenge conventional approaches. We help to transform drug development and commercialization by linking business strategy, industry expertise and deep data to deliver unique and impactful business insights. Quintiles occupies a unique space where insight and execution meet: A traditional CRO can't offer this kind of strategic insight A traditional consulting firm can't draw upon this level of industry experience Our consultants leverage this unique vantage point, one gleaned from decades of experience in drug and biologic development and commercialization, tens of thousands of data sets and a wealth of therapeutic experts around the globe. We offer you the ability to put ideas into action! We are currently seeking a Principal Consultant to join our IT Strategy & Implementation (ITSI) team. Within ITSI, the primary focus of this role will be to create a practice area focused on creating offerings that align to the R&D business domain within Life Sciences. This is a unique role structured for those who are seeking to rapidly advance their career into a Leadership Role through challenge and innovation. The Principal Consultant is expected to manage multiple projects or engagements, execute on deliverables, and take action on Business Development. Those with high energy and enthusiasm, along with an accomplished background in IT management consulting should consider the following details. Specific responsibilities to the role will include: * Development of key offerings in the R&D IT space * Work with the internal Quintiles CRO Business and IT personnel to align the consulting vision to bring a mutual enhancement to both our consulting offerings as well as the CRO offerings * Managing client engagements * Design project research, analysis, and reporting techniques, as well as project plans. * Supervise multiple workstreams * Oversee production of project deliverables including project plans, status reports, interim reports, technical reports * Interview and hire project delivery team members * Manage the development of staff Sample Engagements could include: * Clinical Enterprise Architecture Strategy and Technology Roadmap * Clinical Data Integration and Analytics * Clinical Trial Management System Evaluation and Implementation * Clinical Data Standards Strategy and Implementation * Various Dashboards and Reporting projects * Document Management Strategy and Implementation * Prefer advanced degree in, MBA, MHA, MPH, MS, MA, etc. * 15 years consulting experience in IT in the biopharmaceutical industry * Superior analytical, communication, and presentation skills (sample will be required) * Has solid Information Technology management consulting experience and strong presentation skills * Ability to travel to the client site as necessary * 10 years delivering IT strategies and solutions for R&D focused clients * At least 3 positive references Quintiles can call to verify experience * Proven track record creating successful go to market strategies for solutions. We will want to see a sample of this during the interview process * Well known in the R&D space. This role will be filled by someone with a decent network of senior level individuals and is well respected in the industry2010-07-15 23:37:30United StatesQuintilesNew York1005708NYNew York City, NY16196123http://quintiles.jobs/xml/16196123/job