- Children's Hospital Boston (Boston, MA)
- 77488BRJob Posting Title: Regulatory Affairs and Education Manager , Clinical Research OperationsDepartment:Research-Clinical Research Core ... ProgramsAutoReqId:77488BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:The Regulatory Affairs and Education Manager … more
- Medtronic (Woburn, MA)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Regulatory Affairs Program Manager will lead the strategic planning and ... + Bachelors degree with 5+ years of medical device regulatory affairs experience OR + An advanced...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… more
- Merck (Boston, MA)
- **Job Description** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy ... point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and...achieve optimal results with limited day-to-day direction from the manager . **Preferred Experience and Skills:** + Substantial experience in… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of...of understanding of functions. + May escalate issues to supervisor/ manager for resolution, as deemed necessary. + Mentor other… more
- Takeda Pharmaceuticals (Lexington, MA)
- …where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products as ... GRA CMC Product Lead. Represents and contributes to Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical development and… more
- Actalent (Boston, MA)
- …deliverables including MW, regulatory and PV * Serve as point of contact/alliance manager for selected regulatory vendor(s) * Plan and execute regulatory ... Reg Dev and CMC leads, create content plans and submission timeline for regulatory submissions o Plan kick-off meetings and comment resolution meetings for major… more
- ICON Clinical Research (Boston, MA)
- …societies. * Provide scientific expertise and support to cross-functional teams, including medical affairs , marketing, and regulatory affairs . * Stay abreast ... Manager , Scientific Affairs - Hybrid ICON plc... Manager , Scientific Affairs - Hybrid ICON plc is a world-leading healthcare...future of clinical development. We are currently seeking a Manager , Scientific Affairs to join our diverse… 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)
- …and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Evidence Generation, Global Medical ... Affairs Oncology. You will work cross-functionally with but not...cross-functionally with but not limited to Clinical Operations, Legal, Regulatory , Procurement, Patient Value Access and Safety. + Provides… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. As Manager Regulatory Lead you will be accountable for recommending and ... responsibilities. + Serves as the lead interface between PDT global regulatory affairs , global subject matter experts, international LOCs, EU & Canada strategy,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical trials start-up, active and close out phases. + Proficient knowledge of regulatory affairs , research ethics and the responsible conduct of research + ... The Assistant Regulatory Operations Manager (AROM) is a newly created position and will be responsible for aiding in oversight of the Leukemia disease group's … more
- Olympus Corporation of the Americas (Westborough, MA)
- …you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs ... it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Respiratory (GLMAR) is a board-certified, fellowship trained pulmonary medicine… more
- Olympus Corporation of the Americas (Westborough, MA)
- …you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs ... is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist… more
- Actalent (Cambridge, MA)
- … regulatory vendors. The ideal candidate will have a strong background in regulatory affairs and experience with IND and BLA submissions. Responsibilities + ... (PV) tasks. + Serve as the point of contact and alliance manager for selected regulatory vendors, ensuring timely execution of regulatory submissions. +… 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) ... team to investigate and develop responses to additional information requests from regulatory agencies worldwide. The position will be responsible for reviewing and… more
- Microsoft Corporation (Burlington, MA)
- …the European Union + Experience working on radiology and imaging devices + Regulatory Affairs Certification (RAC) Devices, lead ISO13485 auditor, or equivalent + ... with a technical background and a customer-driven passion for regulatory work, to join our team. This is an...you. We are looking to hire a Senior Program Manager to join our team. Microsoft's mission is to… more
- AbbVie (Worcester, MA)
- …product development, Quality Systems, Product QA, Quality Control, Information Systems and Regulatory Affairs and must demonstrate sound judgment in evaluating ... on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Manager , Quality provides leadership and direction to the Quality Function they are… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Takeda Pharmaceuticals (Boston, MA)
- …Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate ... therapies to patients worldwide. Join Takeda as a Senior Manager , Aggregate Safety Reporting in Cambridge, MA, where you...and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate… more
- State of Massachusetts (Boston, MA)
- …of Banks is currently accepting applications for the position of IT/Cybersecurity/FinTech Manager . This role will be responsible for overseeing a team of examiners ... To learn more about the Division of Banks, clickhere. *As an IT/Cybersecurity/FinTech Manager , you can expect to: * * Manage the supervisory activities associated… more