- Organon & Co. (Jersey City, NJ)
- …to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for implementing Regulatory Chemistry, ... products in accordance with global regulations, guidance's and defined regulatory strategies. The Senior Scientist is responsible for the preparation and… more
- Merck (Rahway, NJ)
- …product withdrawal. + Support new technology development. + Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of ... **Job Description** Under general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... talented and dedicated colleagues while developing and expanding your career. The Senior Director ( Senior Principal Scientist ) has primary responsibility… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck (Rahway, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck (Rahway, NJ)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... colleagues while developing and expanding your career. The Director (Principal Scientist ) has primary responsibility for the planning and directing of clinical… more
- Merck (Rahway, NJ)
- **Job Description** Under the guidance of a senior leader, the Principal Scientist , Outcomes Research-Women's Cancer has primary responsibility for developing ... incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may… more
- City of New York (New York, NY)
- …where they are from or where they live. Position Summary: BHHS's Policy and External Affairs Program seeks a Senior Policy Advisor to lead its health systems ... and Treatment, HIV Epidemiology, HIV Prevention, Policy and External Affairs , Racial Equity and Social Justice Initiatives, STI, and...STI, and viral hepatitis policy advocacy more broadly. The Senior Policy Advisor will report to the Director of… more
- Merck (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The ** Senior Clinical Director (Sr. Principal Scientist )**...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Novo Nordisk (Plainsboro, NJ)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Novo Nordisk (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director, Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the assigned section ... with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical… more