- Pfizer (Andover, MA)
- …ofexperience; OR a master's degree with at least 2 years of experience; ORa PhD with 0+ years of experience; OR as associate's degree with 8 yearsof experience; ... in industrial/professional organization focused on advancing biopharmaceutical development, manufacturing, regulatory practices + Demonstrated leadership in a matrix organization… more
- IQVIA (Boston, MA)
- …of client strategy and objectives. + on technical documents to ensure regulatory compliance in all content created + Identifies, develops, recommends and/or ... as a resource for content development. + Reviews clinical regulatory documents and comms + Understands trends in the...success. **Knowledge, Skills, and Abilities:** + PharmD, MD, or PhD , in a relevant field + At least 5-8… more
- ThermoFisher Scientific (Boston, MA)
- …technical documents, including method SOP, study protocol, technical report, and other regulatory agency facing documents + Be a key Subject Matter Expertise (SME) ... deviation, CAPA and change control + Perform data trending analysis + Perform in-lab experiments as applicable **Education and...to perform the job **(comparable 6+ years')** + OR PhD and previous experience that provides the knowledge, skills,… more
- Amgen (Cambridge, MA)
- …matter expert to support and advise design of characterization studies, data analysis and investigations. + Provide analytical testing support to functions including ... reports, analytical method descriptions and analytical CMC sections in regulatory documents + Lead project teams and/or project sub-teams...5 years of Scientific experience; Or + Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where… more
- Cytel (Cambridge, MA)
- …An experienced Principal Biostatistician with a passion for clinical development and analysis , adept at utilizing advanced statistical methods. In your career you ... with key safety related activities in drug development, including regulatory submission/ISS, periodic safety reporting, Data Monitoring Committees, Health Authority… more
- Sanofi Group (Framingham, MA)
- …for internal documentation and preparation of technical reports required for regulatory documents. May support authoring of regulatory filings. **About ... You** **Education & Experience** : + PhD with 0 years, or Master with 3 years,...to expand and broaden skills + Experience with statistical analysis software **Languages** : + English **Why Choose Us?**… more
- Sanofi Group (Framingham, MA)
- …Responsible for internal documentation and preparation of technical reports required for regulatory documents. May support authoring of regulatory filings + ... technical lead in cross-site, cross-functional teams **About You** **Education and Experience** : + PhD with 2 years, or Master with 5 years, or Bachelor with 7… more
- Takeda Pharmaceuticals (Boston, MA)
- …Access, Global Evidence and Outcomes, Medica Affairs, Clinical Development, Regulatory Affairs, Biostatistics, Global Emerging Markets (GEM; eg, China), Project ... Global Evidence and Outcomes, Medical Affairs, Clinical Science, Legal, Regulatory + OBU 10, EUCAN, GEM **Minimum Qualifications/Requirements:** + Advanced… more
- Sanofi Group (Cambridge, MA)
- …role will act as a thought partner and consultant by presenting scope analysis , strategic options and recommendations ensuring the strategy for formulary access and ... payers. + Lead efforts to anticipate and adapt to changes in the regulatory and reimbursement landscape, ensuring compliance and sustained market access. + Identify… more
- Tufts Medicine (Boston, MA)
- …research skills in a healthcare setting. **Job Description** **Minimum Qualifications** **:** 1. PHD in a relevant field of study **OR** MD 2. Prior experience in ... studies, including experimental protocols, data collection methods, and statistical analysis plans. 3. Analyzes and interprets research data, using appropriate… more