- Sanofi Group (Cambridge, MA)
- …of what you thought was possible. Ready to get started? **Main Responsibilities:** ** Internal & External Safety Expert:** + Provide PV and risk management expertise ... to internal and external customers + Safety expert for product...development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary… more
- Sanofi Group (Cambridge, MA)
- …trials, analyzing trial data, interacting with regulatory agencies, and participating in internal decision making. CRD will work closely with the Global Project ... greater the chance we can produce life-changing therapies. Sanofi has a large internal research team including the Genomic Medicine Unit (GMU), which are committed… more
- Astellas Pharma (Cambridge, MA)
- …Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the ... processes, SOPs, training and quality control, to the highest level of compliance with ICH, GCP and Astellas policies. -Development, mentorship and retention of… more
- Takeda Pharmaceuticals (Boston, MA)
- …program team as a product safety profile and risk mitigation expert for internal (eg, Takeda Safety Board) and external (eg, Independent Data Monitoring Committee) ... lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety information that may… more
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