- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum… more
- Sanofi Group (Cambridge, MA)
- … Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs , Patients Safety & Pharmacovigilance, Therapeutic Area Research & ... level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM...including Clinical Trial Managers and Data Managers), Regulatory Affairs , Patients Safety & Pharmacovigilance, Therapeutic… more
- Sanofi Group (Cambridge, MA)
- …regulatory , statistics, and PM) + The CRD will lead the preparation of clinical documents/reports for regulatory submission and will attend meetings with ... **Job Title:** Clinical Research Director - RBD **Location:** Cambridge, MA...collaboration with the Global Project Head (GPH) and Project Manager (PM), including the relevant components of the GCDP… more
- Takeda Pharmaceuticals (Lexington, MA)
- …/ clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) and ... knowledge. **Job Description** **About the role:** Join Takeda as a Senior Manager , US Medical Information and Review where you will deliver high-quality, balanced… more
- United Therapeutics (Boston, MA)
- …Cross functional collaboration: Partner closely with internal teams such as: marketing, clinical development, medical affairs , public policy, and compliance to ... patient partnership + Enhance patient recruitment for research including clinical trials, medical affairs studies, HEOR studies,...clinical trials and studies + Serve as project manager over assigned areas Minimum Requirements Manager :… more
- Dentsply Sirona (Waltham, MA)
- …in coordination with the respective counterparts (R&D, Operations, Clinical Affairs , Clinical Education, Regulatory , Quality, Compliance and Commercial ... a highly collaborative role and works cross-functionally with R&D, Regulatory , Clinical , Marketing, Commercial, and Regional teams...in advertising, marketing communications and PR + Partner with Clinical Education and Clinical Affairs … more
- State of Massachusetts (Boston, MA)
- …manager filings are properly reviewed and addressed within statutory and regulatory timeframes. * Coordinate Pharmacy Benefit Manager Oversight staff ... of Insurance ("DOI"), an Agency within the Office of Consumer Affairs and Business Regulation, administers the Commonwealth's insurance consumer protection laws… more
- Sanofi Group (Cambridge, MA)
- …is best accomplished through the generation, interpretation and communication of accurate clinical and scientific information. The Senior Manager plays a key ... **Job Title:** Senior Manager - Medical Reviews **Location** : Cambridge, MA...with all corporate and industry policies and legal and regulatory requirements, for all medical affairs activities… more
- Beth Israel Lahey Health (Plymouth, MA)
- …conflict resolution + Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred **Registration/Certification:** ... disclosure of an event when indicated. + The Risk Manager will lead Root Cause Analyses, Failure Mode Effects...of General Counsel as necessary. + Collaborate with our Clinical Services and Medical Staff Officers with tracking/trending of… more
- Sumitomo Pharma (Boston, MA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. **Job ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more