- 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
- J&J Family of Companies (Boston, MA)
- …to project teams and responds to product information requests. * Provide Regulatory Affairs support during internal and external audits. * Assists in the ... Regulatory Affairs Specialist II (Wound Closure... labeling requirements specifications for modified products, and reviews product labeling to ensure compliance. * Provides regulatory… more
- Merck (Boston, MA)
- … Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... **Job Description** Our Regulatory Affairs team bring new medical...Associate Vice President, Therapeutic Area Lead. + Develops worldwide product regulatory strategy to optimize label and… more
- Philips (Cambridge, MA)
- …Insights (CII) business unit._ + _Lead project teams for end-to-end Regulatory Affairs input and deliverables for new product introductions and product ... **Principal Regulatory Affairs Specialist, Software (US Hub...and provides the opportunity to work closely with Clinical Affairs , Product Management and R&D to ensure… more
- Olympus Corporation of the Americas (Westborough, MA)
- …staying **True to Life.** **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist ... proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management… more
- ConvaTec (Lexington, MA)
- …and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business Development and ... medical affairs activities, including, but not limited to new product development, evidence generation and review, risk management, and other activities as… more
- Veterans Affairs, Veterans Health Administration (Brockton, MA)
- …administrative activities are in compliance with agency, accrediting, and regulatory requirements. - Establishes and maintains performance improvement requirements ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus...an area in a social work service, in a care/ product line, or across multiple sites, (eg, multi-division facilities… more
- Pfizer (Cambridge, MA)
- … Regulatory and medical strategies + Proactive benefit: risk assessment, product safety and risk-mitigation activities + Market development/disease awareness ... **ROLE SUMMARY** The Global Product Counsel ("GPC") will serve as counsel for...of the relevant commercial, medical, HEOR, communications, or corporate affairs teams and develop creative and thoughtful solutions to… 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
- Pfizer (Cambridge, MA)
- …leaders from other CMAO functions, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, HV&E , Legal/Compliance, ... + Timely escalation of any quality, human resource, environmental, safety or product issues. + Is accountable...Medical affairs , Pharma QMS Development and Management, Regulatory Affairs , Clinical Quality, GCP audit readiness… 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
- J&J Family of Companies (Boston, MA)
- …UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party ... **Other Locations** NA-United States **Organization** ABIOMED Inc.(6942) **Job Function** Drug & Product Safety Operations **Req ID:** 2406185254W 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
- 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
- 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)
- …development. + Builds and maintains relationships with key stake holders in global regulatory affairs , other R&D and commercial functions to ensure alignment on ... labeling for these products is based on study results, safety data, literature data or other information relevant to...of 10 years' experience in the pharmaceutical industry including regulatory affairs and labeling, 12 or more… more
- Sanofi Group (Boston, MA)
- … Regulatory , etc. to facilitate diligence reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance ... Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining… 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
- Pfizer (Cambridge, MA)
- …Global Clinical Team towards the common goal of approvable worldwide regulatory submissions that meet customer (patient, payer, prescriber) needs, ensuring alignment ... indication-specific input for efficient clinical trial development and response to regulatory authorities + May identify and maximize synergies across indications… more