- Cardinal Health (Boston, MA)
- …hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas, ... of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs. **Responsibilities:** + Collaborate across multiple functions and… more
- Charles River Laboratories (Shrewsbury, MA)
- …and assignments meet client needs. o Maintain the scientific, safety, and regulatory compliance integrity of the entire bioanalytical process. o Provide hands on ... skills. Demonstrated independent analytical and problem-solving abilities. Full understanding of regulatory requirements of study types assigned, as well as Testing… more
- Takeda Pharmaceuticals (Lexington, MA)
- …CMO and vendors, works closely with drug product, quality, regulatory , program leadership, etc. and establish strategic working relationships. **Responsibilities:** ... plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus +...**Competencies:** + A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Leading and executing Human Factors strategy in compliance with regional regulatory guidance. + Driving and overseeing User Research strategy in compliance with ... Human Factors, Industrial Design, and User Research vendors. + Supporting regulatory Human Factors Information Requests. + Developing Human Factors Summary Reports… more
- Baystate Health (Springfield, MA)
- …in matters of corporate law, business transactions, financing, medical staff, regulatory compliance, health law, legal aspects of drug diversion detection, ... of Trustees and physicians on state, federal and other regulatory agency guidelines in matters relating to corporate business...by state/federal agencies such as Attorney General's office, federal FDA or DEA, HCFA, State Board of Registration in… more
- J&J Family of Companies (Danvers, MA)
- …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,...medical device platforms + Experience supporting regulated product development ( FDA , ISO, IEC standards) + Strong problem-solving, communication, and… more
- Pfizer (Cambridge, MA)
- …analysis, providing data interpretation, and contributing to clinical publication and regulatory submissions. + Provides statistical input to study designs and can ... collaborate on the reporting of clinical trial results to regulatory authorities and the scientific community by contributing to...of experience in clinical trials. High aptitude in: * FDA /EMA and other regulations * ICH GCP guidelines *… more
- Philips (Cambridge, MA)
- …dissemination of evidence derived from clinical development endeavors, engaging with regulatory bodies and influential stakeholders to shape policy and industry ... ensuring prompt and thorough resolution in accordance with agreed-upon timelines and regulatory requirements. **You're the right fit if:** + You have a minimum… more
- Norstella (Boston, MA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… 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 ... pharmaceutical companies in maintaining contamination control, product quality, and regulatory compliance-helping ensure safe, effective therapies reach patients faster.… more