- Novo Nordisk Inc. (Plainsboro, NJ)
- …Report to the Director /Associate Director /Lead Regulatory Scientist/ Sr . Manager Regulatory Affairs . Develop and maintain positive rapport ... and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish company goals. External… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Medical Affairs Omnichannel Engagement, role is to support the Director ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...SPOC- Omnichannel Engagement team, enabling and governing the medical affairs omnichannel engagement strategy. The Associate Director -… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, strategy and ... MD, JD preferred Experience Qualifications7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years developing regulatory strategies… 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
- Merck & Co. (North Wales, PA)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal Scientist) has primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... will help develop multiple products. In doing so, the Senior Medical Director will work across different...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global ... leadership while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to ensure Quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Eisai, Inc (Nutley, NJ)
- …Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional area ... want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs...for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director (AD) is responsible for overseeing all activities related to Medical ... regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical...and is also an integral member of the Medical Affairs Team. This position plays a key role in… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Director ( Sr . Principal Scientist) has primary responsibility ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... and related materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC...a difference with. **The opportunity** The Sr . Director , Global Regulatory Affairs CMC ... 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible for identifying and evaluating… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs II Date: May 19, 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
- Ascendis Pharma (Palo Alto, CA)
- The Director , Regulatory Affairs will be...reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to ... and able to have extensive/in-depth interactions with departments outside of regulatory affairs ; ensures timely preparation of Health Authority submissions… more
