- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- …degree (MS, PhD, PharmD) strongly preferredMinimum of 5 years of experience in Regulatory Affairs , with hands-on experience in regulatory submissions across ... credentials and experience.What You'll Do: Lead development and execution of global regulatory strategies for clinical , pre- clinical , and lifecycle… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs , Tactical Implementation, you'll have a ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the ...programs and market. Under the guidance of the Associate Director , you will ensure high-quality, timely, and compliant preparation… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe US Director of Medical Affairs (DMA) for Gynecologic Malignancies (Ovarian, Endometrial and Cervical Cancer) holds primary responsibility for ... the development and execution of regional oncology Medical Affairs strategies and plans for Gynecological Malignancies in the US across indications.- The US DMA for… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible for supporting the ... Affairs strategic vision. This position will report directly to the Executive Director of Medical Affairs . Together with the Executive Director of… more
- Merck & Co. (Upper Gwynedd, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to identify ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Insmed Incorporated (NJ)
- … clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, ... Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help...reviewing & interpreting clinical trial data, authoring clinical study and regulatory communications and documents,… more
- Insmed Incorporated (San Diego, CA)
- … clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as well as ... we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy...of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR,… more
