- Sanofi Group (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… more
- Manulife (Boston, MA)
- …escalate and report on gaps to senior leaders. With a focus on supporting Regulatory Affairs in managing regulatory expectations and maturity assessment for ... The ** Director , Integrity & Security** will lead the Line...and controls are identified and effective in addressing key regulatory expectations. + Coordinate the activities with control owners… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... **Job title** : Clinical Research Director , I and I, Pulmonology **Location:** Cambridge, MA...and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... **Job Title:** Clinical Research Director **Location** : Morristown, NJ Cambridge, MA **About...and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device… more
- Astrix Technology (Boston, MA)
- …strategy, including RNA, genomic, proteomic, and imaging-based markers. + Contribute to global regulatory submissions (eg, INDs, CTAs) and provide medical input ... **Senior Medical Director ** Clinical Boston, MA, MA, US Pay Rate...Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and execute clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …document + Engages with partner global functions (eg Clinical Science, Med Affairs , Regulatory Affairs , Biostats) to ensure alignment of global ... empower you to shine? Join us as a PV Risk Management Scientist/Associate Director . At Takeda, we are transforming the pharmaceutical industry through our R&D-driven… more
- Bayer (Cambridge, MA)
- …(GCL), with input from and consensus with groups such as Research, Early Development, Regulatory Affairs , and commercial functions; + Serve as an internal expert ... to make a real difference, there's only one choice.** ** Director , Early Clinical Leader - Cardiovascular and Kidney** The...research and development projects; + Remain responsible for a global project after PoC until after Market Authorization for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Oversee the process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process ... **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership...+ Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs , and Operations to align strategies… more
- Takeda Pharmaceuticals (Boston, MA)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more