- Sanofi Group (Cambridge, MA)
- …for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities. + Serve as the medical expert in the Clinical Study team, ... cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project… more
- Sanofi Group (Cambridge, MA)
- …within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations + Provide strategic ... development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary… more
- Bristol Myers Squibb (Cambridge, MA)
- …with translational/biomarker strategies for early or late stage clinical trials or investigator sponsored trials in academia + The starting pay rate takes into ... then in effect and may include the following: Medical, pharmacy, dental and vision care . Wellbeing support such as the BMS Living Life Better program and employee… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Institute is a leader in life changing breakthroughs in cancer research and patient care . We are united in our mission of conquering cancer, HIV/AIDS and related ... inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote… more
- Sanofi Group (Cambridge, MA)
- …regulations + Review documents supporting clinical development such as Investigator 's brochure, regulatory documents for IND/CTA, clinical sections of integrated ... of clinical study results + Represent Clinical Development at Health Authorities and incorporating advise into development strategy +...your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide… more
- IQVIA (Boston, MA)
- …according to local requirement. Qualifications * Bachelor's Degree Degree in scientific discipline or health care preferred. Req * Requires at least 2 years of ... available for filing in the Trial Master File (TMF) and verify that the Investigator 's Site File (ISF) is maintained in accordance with GCP and local regulatory… more
- Sanofi Group (Cambridge, MA)
- …Cycle Management/marketed products. + Write nonclinical summaries for clinical Investigator Brochures, INDs, CTAs and NDAs/BLAs, Pediatric Investigation Plans, ... requirements; Writing documents for regulatory submission and interactions with health authorities. Experienced in IND and CTD submissions desired. Experience… more
- Sanofi Group (Cambridge, MA)
- …& EMA submission, filing in Japan and China and answers to questions from health authorities + Provide appropriate medical input & support for all activities related ... and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP +...your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide… more
- Sanofi Group (Cambridge, MA)
- …regulations. + Review documents supporting clinical development such as Investigator 's brochure, regulatory documents for IND/CTA, clinical sections of integrated ... of clinical study results. + Represent Clinical Development at Health Authorities and incorporating advise into development strategy. +...your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide… more
- Sanofi Group (Cambridge, MA)
- …& EMA submission, filing in Japan and China and answers to questions from health authorities + Provide appropriate medical input & support for all activities related ... and/or contribute in the the clinical section of the Investigator 's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP +...your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide… more