- 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
- 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
- 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
- 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
- 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
- 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
- Olympus Corporation of the Americas (Westborough, MA)
- …are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + As a ... you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs more
- Bristol Myers Squibb (Devens, MA)
- …or product quality. + Collaborate with stakeholders, such as quality assurance, regulatory affairs , and site personnel, to gather additional information, discuss ... for efficiency improvements and resource optimization. Inspection Readiness and Regulatory Surveillance: + Review vendor inspection reports received from … more
- Takeda Pharmaceuticals (Lexington, MA)
- …with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC- regulatory Affairs , while serving as an important point of ... experience in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs . + Experience managing technical capabilities in a … more
- Olympus Corporation of the Americas (Westborough, MA)
- …activities centered around professional development and business acumen. Quality Assurance and Regulatory Affairs is responsible for ensuring our products and ... will consist of rotations in the following areas: + Regulatory Affairs : During the regulatory ...for a new product and support the submissions to global regulatory authorities. + Sustaining Design Quality… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Belt preferred. + Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred. + Must be self-motivated with a strong ... seamless quality system integration. Act as an ambassador of global quality harmonization to share, develop, deploy and integrate...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs … more