- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing ... preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional...with the HA(s). Ability to read, analyze and interpret scientific and technical information and regulatory documents.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dashboards to communicate key findings and recommendations to internal stakeholders, including senior leadership and medical affairs teams. Ensure utilization of ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… more
- Merck & Co. (MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… 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 ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Merck & Co. (Boston, MA)
- …innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable ... (mainly Phase 2-3) including study design, medical monitoring, and medical/ scientific interpretation of study analyses,- regulatory reporting, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. 30% overnight ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in… more
- Novo Nordisk Inc. (Seattle, WA)
- …a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between NNI and key ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and … more
- Novo Nordisk Inc. (New Orleans, LA)
- …a deep scientific and clinical education and experience. Within Field Medical Affairs , this position functions as a scientific liaison between NNI and key ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...external customers to further scientific exchange. S/he provides advanced product and … 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 ... pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs , Regulatory Affairs , or related functions within the pharmaceutical or ... expand what's possible for patients with serious diseases. Reporting to the Senior Director, Medical Review Committee (MRC), you'll be responsible for managing the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partners closely with Market Research, Competitive Intelligence, Marketing, Medical Affairs , R&D, Finance, Regulatory , and Market Access internally across ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...several oncology assets and will be reporting to the Senior Director, Global Business Strategy and Analytics. Director is… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline… more
- Insmed Incorporated (NJ)
- …will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program ... you will be a strategic leader, ensuring that development programs meet scientific , quality, regulatory , and commercial standards, while ensuring execution… more
- ThermoFisher Scientific (Greenville, NC)
- …company, all while maintaining full-time benefits. **Position Summary** The Director, Clinical Regulatory Affairs serves as a senior regulatory ... RFIs to support timely trial startup and advancement. The Director, Clinical Regulatory Affairs partners closely with Clinical Operations, Clinical Development,… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …making a meaningful impact on global health and scientific advancement. As a Senior Regulatory Affairs Specialist, you'll provide strategic guidance on ... years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in IVD/medical device industry** **Preferred Fields of Study: Biology,… more
- Danaher Corporation (Austin, TX)
- …intelligence. Learn about the Danaher Business System which makes everything possible.The Senior Director, Medical & Scientific Affairs - Neurodegenerative ... product quality, compliance, commercial/marketing activities and customer interactions. This senior role assists the Chief Medical Officer as the...Medical Officer and is part of the Medical & Scientific Affairs organization, a team of medical… more
- Herbalife (Torrance, CA)
- …**POSITION SUMMARY STATEMENT:** The senior research scientist of NAM/MX scientific affairs will establish product efficacy and safety for Herbalife ... Sr. Research Scientist, Scientific Affairs Category: Research & Development...Develops product efficacy and safety documentation according to local regulatory requirements with the focus on scientific … more
- Abbott (Alameda, CA)
- …people monitor their glucose levels with our new sensing technology. **The Opportunity** This ** Senior Regulatory Affairs Specialist** will work out of our ... growth and career development based on performance. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development… more
- ICON Clinical Research (NC)
- Senior Manager, Regulatory Affairs - IVD ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an ... - IVD Location: US Remote, Portland, OR area preferred We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team.… more
- Takeda Pharmaceuticals (Boston, MA)
- …KOL engagement strategy, and Independent Medical Education strategy. + Serve as the senior medical point of contact for external scientific engagement strategy ... professional societies, and key opinion leaders (KOLs). As a senior leader within the GMAO Medical Capabilities team, this... discipline with 10+ years of experience in medical affairs , scientific engagement, strategic operations or related… more
