- Merck & Co. (Rahway, NJ)
- …enterprise level strategies and leads cross-functionally with the Global Medical and Scientific Affairs Therapeutic Area (GMSA TA) teams to translate Global ... (GCTO) and the broader Global Clinical Development (GCD)Coordinates with Global Medical Scientific Affairs to ensure team support of IIS with therapeutically… more
- Merck & Co. (Rahway, NJ)
- …Regulatory Affairs with prior experience as a Global Regulatory LeadDemonstrated scientific knowledge, writing ability, effective communication and ... regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.Provide final… 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 ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Merck & Co. (Rahway, NJ)
- …Research, Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance, Regulatory Compliance, Scientific Consulting {+ ... studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… more
- Merck & Co. (Rahway, NJ)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs , including reviews/approvals of Change Control Reports ... New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior … more
- Eisai, Inc (Nutley, NJ)
- …the broader Medical Affairs team as well as the Publications & Scientific Communications teams and other departments as appropriate. This role will also be ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborations within and across line functions, eg Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Operations. Formulates strategic ... by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
