- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA ... with the following requirements: Master's degree in Regulatory Affairs or related field plus 2...working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs , Marketed Products in ... EU, Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery… more
- 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)
- As a Regulatory Affairs Program Manager ,...minimum of 5 years' experience in regulatory affairs within the FDA regulated, global medical ... you will be an important member of the Philips Regulatory Affairs Centralized Services Team, committed to improving billions of lives worldwide. **Your role:** +… more
- ThermoFisher Scientific (Waltham, MA)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Edwards Lifesciences (Boston, MA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... international regulatory environments....us and be part of our inspiring journey. The Manager , Medical Writing will provide guidance, develop, and 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)
- …+ Participates in strategic and operating planning activities in partnership with the Global Head of Clinical Affairs , in translating corporate and divisional ... are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + As a… 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 (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager , Global Regulatory Labeling Strategy where you will be ... issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk...the Labeling cross functional teams including clinical, safety, medical affairs , and commercial, to ensure highly effective communication of… more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... Administration Position Description: The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …more of the following Clinical Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations, ... The Business Analysis & Operations Senior Manager will drive consistency across the Global...Quality. Experience working within and knowledge of GXP/GCP and regulatory ICH 6 guidelines. Strong knowledge of technologies such… more
- Pfizer (Cambridge, MA)
- …and flu vaccines, antivirals, and diagnostic assets. The Global Scientific Affairs COVID & Flu Senior Manager will deliver timely feasibility assessments, ... evolve, standards and procedures. The Global Scientific Affairs COVID & Flu Senior Manager will...and other Vaccines-relevant experience is highly desired. + Understanding global regulatory guidance for appropriate use 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) ... The training specialist will support the management of the global training process by collaborating with global ...development and use of reports in support of audits, manager accountability, and business partner requirements. + Organize and… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Senior Manager , Medical Congress and Ad Board Innovation is responsible for operational execution of key logistical tasks for major medical ... addition, this role supports the design and implementation of an innovative Medical Affairs Ad Board Channel strategy across Pfizer Business Units. In this role, you… 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)
- …the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and ... Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- embecta (Andover, MA)
- …components - is designed to support the varying needs of our diverse and global employees. The Senior Manager , Systems Engineering will provide leadership to ... embecta is a global diabetes care company that is leveraging its...peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory… more
- ThermoFisher Scientific (Waltham, MA)
- …on US and Canada + Ensure strategic pharmacovigilance support in the region to Regulatory Affairs , Medical Affairs , US Commercial function, and the broader ... the region. Assess current processes to ensure adherence to US safety regulatory requirements and where needed enhance and/or develop new processes while assuring… more
- Philips (Cambridge, MA)
- …Reimbursement Department. **In this role you will be responsible for:** + Partner with Global Clinical and Medical Affairs , Marketing, and Market Access teams to ... within clinical trials to enable negotiations, reimbursement, and patient access with global payers and regulatory decision makers. + Support the development… more