- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. **Management of Local Exceptions and LOC Interactions** + Manages… more
- Sanofi Group (Cambridge, MA)
- …cross-functional teams to ensure the successful planning and execution of medical affairs activities, clinical trials, and product support. This position will be ... Oncology portfolio, including products at various stages of development. + **Medical Affairs Expertise** : Provide medical affairs expertise for solid tumor… more
- Cardinal Health (Boston, MA)
- …medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across multiple functions ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch… more
- Takeda Pharmaceuticals (Lexington, MA)
- …information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) ... 2) medical and scientific slides housed in the Medical Affairs slide repository, and 3) other relevant publications in...and issues at sales meetings to assure legal and regulatory compliance. + Conduct strategic assessment (gap analysis) of… more
- Sanofi Group (Cambridge, MA)
- …effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining ... full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by ensuring excellence… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of regulatory guidelines and compliance requirements relevant to medical affairs activities. + Proven leadership and people management skills and the ability ... and strategic partners, and advance digital innovation and data analytics in medical affairs . Under the direction of this role, the teams will ensure the timely… more
- Chiesi (Boston, MA)
- …narratives for global stakeholders. + Partner with R&D, clinical development, regulatory , and commercial teams to ensure seamless, consistent messaging across all ... global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA, EMA, and other health authorities). + Leverage AI… more
- Takeda Pharmaceuticals (Boston, MA)
- …with Pharmaceutical Sciences team to generate preclinical data package for regulatory filings (IND) and translatable biomarker strategies for patient stratification. ... various key stakeholder functions (eg. Clinical, Clinical Operations, Medical Affairs , Commercial, Medical Writing) and represents Nonclinical and Translational… more
- Takeda Pharmaceuticals (Lexington, MA)
- …strategies and tactical plans. + Thorough understanding of legal, compliance, and regulatory guidelines related to medical affairs in the pharmaceutical ... Medical Alliances group on external partnership, as appropriate (eg, external affairs /government affairs ). + Develop strategic medical education plan to… more