- Kelly Services (Boston, MA)
- …assurance protocols and procedures. + Collaborate with cross-functional teams to ensure compliance with regulatory standards. + Analyze quality data and trends ... Biotechnology). + Proven experience in quality assurance within the biotechnology or pharmaceutical industry. + Strong knowledge of regulatory requirements and… more
- Bristol Myers Squibb (Devens, MA)
- …production. + Provide investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements. + ... cause analysis and CAPAs). + Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations. + Review and… more
- Sanofi Group (Cambridge, MA)
- …well as contracting. Candidates should have experience advising global pharmaceutical companies on marketing, distribution, promotion, scientific exchange, and ... furthers the company's strategic goals while effectively managing legal and regulatory risks and upholding the company's integrity and reputation. Additionally, the… more
- ThermoFisher Scientific (Boston, MA)
- …employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-time benefits. **Key ... ensure accuracy and completeness of information presented in analytical documents and regulatory filings. Assist with comment resolution if needed + Support internal… more
- Integra LifeSciences (Braintree, MA)
- …The role works closely with Product Development, Project Management, Regulatory , Marketing and Medical Affairs. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + ... development and sustaining/remediation projects. + Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements. + Identify and… more
- ICON Clinical Research (Boston, MA)
- …Offering expert medical and scientific consultation throughout project lifecycles. + Ensuring compliance with ethical, legal, and regulatory standards in medical ... Pulmonologist + A minimum of 2 years Clinical Research experience within Academia, Pharmaceutical , Biotech or other CRO industry. + Understanding of regulatory … more
- Sanofi Group (Cambridge, MA)
- …Our Medical function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to support patients' needs. ... countries + Work effectively within the established corporate and industry compliance guidelines **About You** **Education:** Advanced degree in a scientific… more
- Sanofi Group (Cambridge, MA)
- …including medical science, clinical trials, marketing strategies, and key publications. + ** Regulatory and Compliance Oversight** : Oversee the medical review ... and approval of regulatory documents, ensuring adherence to company standards and government/industry...At least 5 years of progressive experience in the pharmaceutical or biotech industry working in Medical Affairs and/or… more
- Takeda Pharmaceuticals (Boston, MA)
- …for all applications and systems to support future maintenance, upgrades, and regulatory compliance . + Follow secure coding practices that align with ... is at the forefront of digital transformation in the pharmaceutical industry-identifying capability gaps, designing and deploying digital solutions,...ethical data use, regulatory requirements, and industry standards. + Collaborate closely with… more
- Boston University (Boston, MA)
- …of IRB-approved research studies to ensure that research is conducted in compliance with applicable regulations, policies, and guidance. These include both for-cause ... the QA role, this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the… more