- ICP Group (Andover, MA)
- …and the Asia Pacific region. ICP Group is looking to identify a Product Safety & Regulatory Affairs Specialist. The PSRA Specialist ensures that all ... credential portfolios. + Review all printed materials, including product labels, for compliance with regulatory requirements,... product compliance, regulatory compliance and/or product stewardship experience. + BS in Safety ,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …lives healthier, safer, and more fulfilling.** **Job Description** The Specialist, I - Regulatory Affairs will support the maintenance of EU MDR technical ... documentation and conduct other elements of sustaining Regulatory Affairs including maintaining "state of the... support on the creation and maintenance of master product data. + Provide support in the maintenance and… more
- Merck (Boston, MA)
- …, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- J&J Family of Companies (Raynham, MA)
- …* Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... product development and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential… more
- J&J Family of Companies (Raynham, MA)
- …* Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... product development and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential… more
- AbbVie (Waltham, MA)
- …at the regional/local level. + Participation in design and execution of clinical trial safety , product safety and risk management plans. Responsible for ... specialist medical/scientific strategic and operational input into core medical affairs activities within their TA inclusive of healthcare professional/provider...routine and adhoc safety monitoring reports to regulatory agencies. May… more
- Philips (Cambridge, MA)
- **Senior Director of Clinical Affairs ** Delivers clinical knowledge, experience and expertise across the whole value chain from ideation to end-of-life. Focus in ... topics to support strategy development and strategy execution. + Build Clinical Affairs , Market Access and outcomes research capability and governance (together with… more
- Takeda Pharmaceuticals (Boston, MA)
- …among functions represented at the Labeling cross functional teams including clinical, safety , medical affairs , and commercial, to ensure highly effective ... executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority...and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. +… more
- Abbott (Westford, MA)
- …engineering, safety management quality, environmental science, scientific discipline or regulatory affairs + Technical experience in chemical, mechanical or ... is accurately tracked in database + Work with Corporate Regulatory / Product Stewardship team and provide updates as...We offer: + **A fast-paced work environment** where your safety is our priority (Manufacturing roles only) + Production… more
- Novo Nordisk (Lexington, MA)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... with no direct reports. Essential Functions + Support establishment of the product safety profile: + Support development and updates to the minimum mandatory … more
- Olympus Corporation of the Americas (Westborough, MA)
- …Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... and our core values by staying **True to Life.** **Job Description** The Product Quality Engineer is responsible for the design, development and management of… more
- State of Massachusetts (Boston, MA)
- …of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making sure the professionals ... trades and professions. DOL also licenses and regulates the Office of Public Safety and Inspections (OPSI), and the Office of Private Occupational School Education… more
- Olympus Corporation of the Americas (Westborough, MA)
- …perspective. Matrixed relationships within Olympus will include colleagues from Quality Assurance, Regulatory Affairs , IP R&D teams, and the Infection Prevention ... providing holistic leadership for all IP functions across the product lifecycle to ensure that patient safety ...safety and IP topics for benefit/risk sections of regulatory documents and preparation for meetings with regulatory… more
- Pfizer (Cambridge, MA)
- …with an understanding of pharmaceutical business operations (including product development), products, strategic thinking skills, leadership ability, and ... clear and effective medical strategy, enabling the effective pull through by the Medical Affairs local teams to unlock the full global potential of our existing and… more
- Sanofi Group (Cambridge, MA)
- …Collaborate with colleagues in Medical Affairs , Commercial, Research and Development, Drug Safety , Sales & Marketing and Regulatory to ensure success of the ... review and approval of medical and scientific content of Regulatory , Safety , Scientific Affairs , Medical...across brands (where possible) measurable policies regarding customer and product medical education within the team to assure a… more
- J&J Family of Companies (Cambridge, MA)
- …project management, quality monitoring & compliance, data management, global medical safety , biostatistics, regulatory affairs , clinical supplies unit, ... Data Monitoring Committee (IDMC) and adjudication meetings as needed. + Assists Regulatory Affairs in determining requirements for any corrective actions or… more
- Sanofi Group (Cambridge, MA)
- …products. Collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs , and product management, to drive ... will collaborate with cross-functional teams, including software engineers, quality assurance, regulatory affairs , and product management, to drive… more
- ThermoFisher Scientific (Cambridge, MA)
- …partners within the region. Assess current processes to ensure adherence to US safety regulatory requirements and where needed enhance and/or develop new ... on US and Canada + Ensure strategic pharmacovigilance support in the region to Regulatory Affairs , Medical Affairs , US Commercial function, and the broader… more
- Takeda Pharmaceuticals (Boston, MA)
- …among functions represented at the Labeling cross functional teams including clinical, safety , medical affairs , and commercial, to ensure the highest level ... of drug development, which may include one high complexity product and updates to or creation of a new...executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority… more
- Sanofi Group (Cambridge, MA)
- …Medical function serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' needs. ... Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety and Clinical Research (Phase IIIB-IV and Investigator Sponsored Trials)… more