- ThermoFisher Scientific (Waltham, MA)
- …guidelines (eg, ICH), and requirements of the FDA and other international regulatory agencies. + Attentive to detail and quality of documents, thorough and ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- Curia (Boston, MA)
- …mitigation activities for equipment. + Provide technical support to clients for regulatory filings, change control and quality impact assessments. + Develops ... transfer, qualification and validation of biologics based analytical methods using the ICH, FDA and EMA guidelines and regulatory requirements. + Multiple years… more
- Bristol Myers Squibb (Devens, MA)
- …Practices. + Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines ( FDA , EU) and the know how to work and ... manufacturing areas. **Duties/Responsibilities** + Lead and support administration of quality and laboratory applications including their software development life… more
- Philips (Cambridge, MA)
- …creating successful submission(s) of AI-enabled solutions, or evaluating AI submissions at the regulatory side ( FDA ) would be a plus. + Your skills include: ... at external events in the USA. + Monitor AI regulatory developments in the USA on state and federal...won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work… more
- Sanofi Group (Cambridge, MA)
- …and Regulatory teams to interact and respond to request from the global regulatory agencies ( FDA , EMA and other agencies) + Co-lead with the scientific ... Our Medical Affairs function serves as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- Takeda Pharmaceuticals (Boston, MA)
- …compliance metrics to identify trends and escalate emerging risks. + Support regulatory inspections and internal audits, ensuring high- quality deliverables. + ... to translate complex concepts into actionable insights. + Experience supporting regulatory inspections and managing cross-functional quality deliverables. +… more
- Philips (Cambridge, MA)
- …financing and lease arrangements. + Deliver strategic legal guidance on regulatory and compliance matters impacting healthcare technology transactions, including the ... Anti-Kickback Statute and Safe Harbors, HIPAA, UCC, FDA regulations, antitrust, and state/federal privacy laws. Partner with...won't stop until everybody everywhere has access to the quality of healthcare that we all deserve. Do the… more
- Charles River Laboratories (Wilmington, MA)
- …an experienced professional with expertise in establishing effective scientific and regulatory strategies to advance new medicines through the various stages of ... products. Successful individuals have knowledge of domestic and international regulatory expectations and requirements; and can provide intellectual input in… more
- Cytel (Cambridge, MA)
- …management, safety/pharmacovigilance, biostatistics, and medical writing teams to maintain high- quality data that meet global regulatory standards. **Medical ... Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to… more
- Pfizer (Cambridge, MA)
- …of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-Clinical, Pharmacology, Quality Assurance. ... of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results… more