- 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
- J&J Family of Companies (Danvers, MA)
- …product features, technical requirements, and specifications aligned with business needs. ** Regulatory & Quality Support:** + Ensure engineering activities align ... with regulatory requirements and internal quality standards. + Support documentation, validation, and verification activities to maintain compliance **Process… more
- Editas Medicine (Cambridge, MA)
- …monitoring and reporting to ensure scientific rigor, meeting timelines, budgets, and regulatory compliance + Deliver high- quality safety reports to support ... through nonclinical development including managing GLP and non-GLP studies, and regulatory submissions + Familiarity with FDA /EMA/ICH guidelines and proven… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …regulatory requirements, operational efficiency, and alignment with corporate quality objectives. The position drives governance, technology enablement, and ... within the Learning Center of Excellence (CoE) under Global Quality . This role is responsible for overseeing the end-to-end...teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.).… more
- Element Materials Technology (Acton, MA)
- …pharmacies, and pharmaceutical companies in maintaining contamination control, product quality , and regulatory compliance-helping ensure safe, effective ... **Overview** Join Element's Acton laboratory, a cGMP-certified, FDA - and DEA-registered facility specializing in microbiology, environmental monitoring, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …commercial products and lifecycle management activities. + Work closely with R&D, Quality , Regulatory , Procurement, and external suppliers to ensure seamless ... products and device manufacturing. + Active engagement with Product Operations Lead, Quality , Regulatory , and External CMO Operations & Supply groups to… more