- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Astellas (Westborough, MA)
- …Associate II, Analytical Development Senior Project Manager, Technical Operations Senior CMC Regulatory Affairs Manager, Cell/Gene Therapy Manager ... CMC Regulatory Affairs , Gene Therapy Associate Director CMC Regulatory Affairs , Gene Therapy Developing innovative therapies is one of the most… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Global Medical Affairs will provide medical leadership for medical affairs ... supportive tactics for Oncology. Under the direction of the Senior /Executive Medical Director , this role will be...Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …(eg, CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling ... and under the supervision of the Global Labeling Strategic Director , the GLL is responsible for:- Developing, maintaining, and... regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities ... execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... and scientific communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... with talented and dedicated colleagues while developing and expanding your career.The Director ( Sr . Principal Scientist) has primary responsibility for the… more
- Merck & Co. (Rahway, NJ)
- …- Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... entire cycle of clinical development,-including-study design, placement, monitoring, analysis, regulatory reporting, and publication.-- - Specifically, the Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with external vendors and to contribute to study logistical conductance; with Regulatory Affairs to align study with health authority requirements; with ... design, and conductance of early development clinical studies; the preparation of regulatory documents to file IND and report studies; and the representation of… more
- Lundbeck (WA)
- …opportunity - Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager, State Policy and Strategy position is responsible for serving as ... related to the state policy environment and collaborating with Government Affairs and cross-functional partners to ensure patient access to therapies, optimize… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be… more
- Novo Nordisk Inc. (Stamford, CT)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Senior Field Director . Serves as organization spokesperson on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to make a difference? Willing to hire at the Senior ML level commensurate with experience. The Position Builds… more
- Boehringer Ingelheim (St. Joseph, MO)
- …programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/Associate Director , Regulatory Affairs Pharma Safety & Efficacy you ... will: Act as Regulatory Affairs (RA) team member in projects...Profile and Quality Target Profile. + Works with more senior RA team members to provide consistent regulatory… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Feb 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 ... a difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help… more
- Taiho Oncology (Princeton, NJ)
- Sr . Director , Regulatory Affairs Strategy...Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs ... and Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and...and contractors. Performance Objectives: + Responsible to represent the Regulatory Affairs position and decision in assigned… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: Mar 22, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job ... a difference, and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs II will have a knowledge of global… more