- Takeda Pharmaceuticals (Lexington, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management ... requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on and/or lead… more
- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... patients around the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and… more
- Philips (Cambridge, MA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... compliant by preparing comprehensive global regulatory strategies for new devices and...regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Operations; resolves a wide range of issues in creative ways. +… more
- Olympus Corporation of the Americas (Westborough, MA)
- …entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Respiratory (GLMAR) is a board-certified, ... as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the...Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs… more
- Olympus Corporation of the Americas (Westborough, MA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, ... as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the...Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs… more
- ICON Clinical Research (Boston, MA)
- …to support scientific communication, medical education, and knowledge dissemination across global markets. ** Manager , Scientific Affairs - Hybrid** We ... Manager , Scientific Affairs - Hybrid ICON plc...scientific expertise and support to cross-functional teams, including medical affairs , marketing, and regulatory affairs .… more
- Google (Cambridge, MA)
- … Affairs and Public Policy team, you'll be part of a diverse global government affairs team, working across regions, product areas, and functions. You'll ... them. Preferred qualifications: + Experience in government relations, political campaigns, public affairs , external affairs in the northeast region. + Experience… more
- Boston University (Boston, MA)
- …documents, serving as an expert on tax compliance matters, maintaining currency on regulatory changes, leading special projects related to tax and regulatory ... with key departments such as the Investment Office and the Office of Global Programs Pay Rage: Minimum $78,000, Midpoint $117,000, Maximum $156,000. Salary is based… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs SOPs and processes. + Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external ... **About the role:** You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR) and Externally… more
- Olympus Corporation of the Americas (Westborough, MA)
- …an entity other than @Olympus.com, it is likely not legitimate. **Job Description** The Global Lead of Respiratory Clinical Affairs reports directly to the ... + Participates in strategic and operating planning activities in partnership with the Global Head of Clinical Affairs , in translating corporate and divisional… more
- AbbVie (Waltham, MA)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards....to 5-year time horizon, and is accountable to the Global Head of Clinical Affairs . + Other… more
- Pfizer (Cambridge, MA)
- …matrix organization and interacts with Epidemiologists, Biostatisticians, Clinical Operations, Global and Regional Medical/Scientific Affairs , Pfizer Research ... **ROLE SUMMARY** The Clinical Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …purchasers, payers and policy makers + Coordinate with Medical & Clinical Affairs , Regulatory to ensure appropriate support and guidance when addressing ... it is likely not legitimate._ **Job Description** The Director, Global Health Economics & Market Access is part of...Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate...prioritize individual and teamwork loads. + Expert knowledge of Global regulatory requirements. + Experience in vendor… more
- Abbott (Burlington, MA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... get on with their lives. **THE OPPORTUNITY** **Scientific Communications Manager ** We have an exciting opportunity for the right...for the right candidate to join our growing clinical affairs team within Abbott Heart Failure. The job purpose… more
- Olympus Corporation of the Americas (Westborough, MA)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... applicable Customer Quality commitments to US FDA, and other Regulatory Authorities as applicable. + Leads cross site /...of the team. + Participates in the implementation of Global Customer Quality initiatives and programs as required. +… more
- Fresenius Medical Center (Waltham, MA)
- …device manufacturing industry or pharmaceutical industry. Experience in quality assurance, regulatory affairs , compliance preferred. + 3+ years of experience ... Ensure the quality measurement system is consistently applied across global sites and validated/verified per regulatory requirements....as a Manager preferred. Strong project management skills. + Demonstrated ability… more