- Dana-Farber Cancer Institute (Brookline, MA)
- …partners, including other Harvard Medical School-affiliated hospitals. + Ensure the Sponsor- Investigator and study team adhere to current FDA regulations, applicable ... staff as well as research support personnel. + Must have expertise in research ethics and the responsible conduct of research. Located in Boston and the surrounding… more
- Astellas Pharma (Boston, 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 ... in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific… more
- Sanofi Group (Cambridge, MA)
- …packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of ... Plan + Writes/reviews answers to clinical questions from Health Authorities and IRB/ Ethics Committees and investigators + Reviews Key Results Memos, Clinical Study… more
- Takeda Pharmaceuticals (Boston, MA)
- …preparation of responses to safety-related inquiries from regulatory agencies and ethics committees, MAAs, NDAs, and BLAs; provide medical safety expertise, medical ... information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. Up to 10% domestic… more