- Merck (Boston, MA)
- …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
- Grifols Shared Services North America, Inc (Fall River, MA)
- …ensures compliant execution of field medical plans, strategy, and activities within Medical Affairs , as aligned with goals and objectives. This position is a remote ... with the Medical Directors, National MSL Sr Director, and North America Medical Affairs Sr Director to develop field medical strategies and tactics + Responsible for… more
- Sanofi Group (Cambridge, MA)
- …Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs , Patients Safety & Pharmacovigilance, Therapeutic Area ... Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs , Patients Safety & Pharmacovigilance, Therapeutic Area… more
- ConvaTec (Lexington, MA)
- …project work + **Scientific & Technical Labs** to execute testing, as required. + ** Regulatory Affairs ** to collaborate on requirements as well as gain early ... including Applied Research, New Product Development, Marketing, Medical and Clinical Affairs , Market Access, and External Innovation, to develop technologies that… more
- Merck (Boston, MA)
- …immunology, neurology, cardiometabolic and others as needed by the pipeline. + Work with Regulatory Affairs to ensure that regulatory documents (eg, IDEs, ... stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the role requires overseeing CDx development,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Japan Payer Marketing and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global ... + Market Access, Pricing, Advocacy, Biostatistics, Global Evidence and Outcomes, Medical Affairs , Clinical Science, Legal, Regulatory + OBU 10, EUCAN, GEM… more
- Sanofi Group (Framingham, MA)
- …development and marketed product objectives. + Represent GRA CMC on GRAT (Global Regulatory Affairs Team) + Assures effective involvement with change control ... possible. Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD , PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** + ... personal lives. Read more: careers.bms.com/working-with-us . **Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:** The selected candidate will… more
- Sanofi Group (Cambridge, MA)
- …Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical ... to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …data scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end statistical expertise ... approve tables, listings and graphs specifications. + Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and… more