- Takeda Pharmaceuticals (Lexington, MA)
- …and Global functional groups such as Medical, Publications, Medical Information, Regulatory , Statistics, and Legal. * Provide support to respective Product Medical ... as a liaison between USM Scientific Communications, USM and Global Medical Affairs , Global Publications, and external stakeholders. * Oversee the implementation and… more
- Bristol Myers Squibb (Cambridge, MA)
- …plan (IDP) in partnership with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops strategy for orphan drug ... maximize program impact + Actively supports Investor Relations and Public Affairs in managing external BMS communications **Integrates commercialization inputs and… more
- Astrix Technology (Boston, MA)
- …Collaboration: Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that ... decisions. + Compliance and Reporting: Ensure all activities comply with regulatory standards and company policies, and accurately document interactions and insights… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners, such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory ... (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with...AND SKILLS:** **Education & Experience** + Pharm D. or PhD with 8+ years of working experience in a… more
- Genentech (Boston, MA)
- …best practices + Partner closely with senior leadership across PD-DSA, clinical development, regulatory affairs , and data science teams to shape the future of ... primary liaison between the Biostatistics function and key stakeholders across Clinical, Regulatory , and Data Science teams to drive alignment and shape outcomes for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …* Strong partnership with Quality Business Units Heads, R&D Quality, BioLife, DD&T, Regulatory Affairs , Site Quality Heads, Site QC Heads, and other global ... Operational, and Process Qualifications at Takeda to ensure compliance with GxP regulatory and quality standards while maintaining the integrity of data * Oversees… more
- Takeda Pharmaceuticals (Boston, MA)
- …assessment document + Engages with partner global functions (eg Clinical Science, Med Affairs , Regulatory Affairs , Biostats) to ensure alignment of global ... procedures or requested by supervisor. Minimum Requirements/Qualifications: + Associate Director: PhD /PharmD/DO/MD + 3 years; OR Masters + 5 years; OR Bachelors… more
- Astrix Technology (Boston, MA)
- …+ Collaborate with cross-functional teams, including preclinical, clinical operations, and regulatory affairs , to integrate and execute clinical strategy. + ... programs worldwide. + Ensure adherence to international clinical development and regulatory standards. **Qualifications:** + MD or MD/ PhD with specialization… more