- 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 ... to include development of standard written and verbal responses, including Clinical Dossiers, Letters and Frequently Asked Questions (FAQs), and periodic review… 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
- Sanofi Group (Cambridge, MA)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of...The incumbent will work closely with key stakeholders including clinical , medical affairs , Industrial Affairs … more
- Sanofi Group (Cambridge, MA)
- …dotted-line management toward all GPT members, including eg project management, clinical operations, regulatory , safety, translational medicine, statistics, CMC, ... The GPH will be delegated such responsibilities as interaction with regulatory /health authorities (HA), approval of documents and product label, as appropriate.… more
- Takeda Pharmaceuticals (Boston, MA)
- …the employee also works closely with various key stakeholder functions (eg. Clinical , Clinical Operations, Medical Affairs , Commercial, Medical Writing) ... discovery, nonclinical and clinical programs. + Partners with Clinical , Pharmaceutical Sciences, Computational Biology, Medical Affairs , Commercial, Business… more
- Bristol Myers Squibb (Cambridge, MA)
- …the relationship to clinical trial design + In partnership with Medical Affairs , supports development of KOL plans and engagements, and leverages KOL input in ... along with expertise in one or more of the relevant areas (eg, clinical , regulatory , project planning and management, medical, commercial development) + Prior… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …strategies and tactical plans. + Thorough understanding of legal, compliance, and regulatory guidelines related to medical affairs in the pharmaceutical ... Collaborate with relevant Global functions to highlight US-specific needs to influence clinical study endpoint decisions to ensure US needs are represented in… more
- Chiesi (Boston, MA)
- …trends into impactful narratives for global stakeholders. + Partner with R&D, clinical development, regulatory , and commercial teams to ensure seamless, ... global early access and compassionate use programs, ensuring compliance with varied regulatory frameworks (eg, FDA, EMA, and other health authorities). + Leverage AI… more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... global submission plans and Health Authority interaction plans. + Provide strategic regulatory input to key development documents, including clinical protocols, … more
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