- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA , EMA, ICH). + Prepare documentation and ... outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs, and Technical Operations to ensure supplier quality… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- Lilly (Boston, MA)
- …studies from planning to close-out, ensuring adherence to timelines, budgets, and regulatory guidelines ( FDA , EMA, GCP, ICH) using a risk-based approach. ... alignment with company goals. + Partner with cross-functional teams (eg, Clinical, Regulatory , Supply Chain) to support the strategic development and execution of… more
- Element Materials Technology (Acton, MA)
- **Overview** Join Element's Acton laboratory, a cGMP-certified, FDA - and DEA-registered facility specializing in microbiology, environmental monitoring, and ... compliance testing for sterile compounding and drug manufacturing environments. Our Acton team supports home infusion centers, hospital pharmacies, and… more
- Parexel (Boston, MA)
- …experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be ... adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE… more
- Charles River Laboratories (Shrewsbury, MA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and… more
- Charles River Laboratories (Wilmington, MA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on… more
- Sanofi Group (Cambridge, MA)
- …+ Experience with vendor management and contract coordination + Knowledge of FDA /EMA regulatory requirements **WHAT WE OFFER** **Professional Growth** + ... to make a significant impact on Sanofi's digital transformation in drug discovery and translational research. **Key Responsibilities** Product Ownership & Execution… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... into actionable user stories and system requirements. + Integrate input from regulatory , marketing, and implementation teams to maintain compliance and accuracy in… more
- Pfizer (Cambridge, MA)
- …solutions into business workflows, ensuring alignment with standardized processes, regulatory requirements, and enterprise architecture principles. + Develop and ... that fully comply with Industry regulations and quality standards ( FDA , GxP). + 5+ years of experience leading the...medical leave, and health benefits to include medical, prescription drug , dental and vision coverage. Learn more at Pfizer… more