- Takeda Pharmaceuticals (Lexington, MA)
- …liaison between Biologics Business Unit senior management and Global Quality, Regulatory Affairs , and Operations, fostering seamless communication and decisive ... and processes + Broad knowledge and experience within the GMP environment, and regulatory affairs + Thorough understanding of applicable regulations and guidance… more
- Cardinal Health (Boston, MA)
- …medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across multiple functions ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Sanofi Group (Cambridge, MA)
- … etc.) + Partner effectively with relevant departments (eg Commercial, Clinical Development, Regulatory Affairs , Medical Affairs , HEOR ) to influence the ... Regular, close contact with: + GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) + HEVA leads + Major Local Market Access… more
- Astellas Pharma (Cambridge, MA)
- …enterprise objectives. -Play a strategic lead role, in collaboration with Research, Regulatory Affairs and Early Development and Translational Sciences, to ... and managing strong alliances with the Oncology Research, medical affairs , commercial and business development organizations to enable end-to-end execution.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Medical IISR clinical trials in assigned TA. Ensure coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from ... Research and program management experience working with clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development… 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
- 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
- Pfizer (Cambridge, MA)
- …design, conduct, and analysis. They work closely with other functions such as regulatory affairs , pharmacovigilance, biostatistics, and medical affairs to ... ensure that the clinical development program meets the scientific, ethical, and regulatory standards. They also provides medical expertise and guidance to the… more
- Republic Services (Norwood, MA)
- …management, coordination of meetings for large regulatory projects. + Supports the Regulatory Affairs management in project tasks as they arise. + Performs ... **POSITION SUMMARY:** The Regulatory Coordinator provides administrative support with regulatory...The Regulatory Coordinator provides administrative support with regulatory compliance matters including but not limited to maintaining… 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