- Olympus Corporation of the Americas (Westborough, MA)
- …core values by staying **True to Life.** **Job Description** The Specialist I - Regulatory Affairs will support the maintenance of EU MDR technical documentation ... and conduct other elements of sustaining Regulatory Affairs including maintaining "state of the art". In addition, this position will support the regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and ... therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the...various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support ... clinical practice, training, and education. + Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs , clinical… more
- Orchard Therapeutics (Boston, MA)
- …People manager role and responsibilities + Post-approval space Medical Affairs activities in the United States + Government and industry guidelines, regulations, ... communication, and compliance with customers Preferred experience with one or more key therapeutic areas: + Medical Affairs role within the context of clinical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to address potential issues. **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, GI... regulatory requirements. . Understand broad concepts within Regulatory Affairs and potential effects across the… 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 (Lexington, MA)
- …medical information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand ... 2) medical and scientific slides housed in the Medical Affairs slide repository, and 3) other pertinent publications in...slide repository, and 3) other pertinent publications in the therapeutic areas and serve as a resource to other… 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) ... values by staying **True to Life.** **Job Description** The Manager , Senior Global MDR Submission is responsible for managing...for managing Market Quality- COE MDR team for the regulatory assessment and submission of Medical Device Reports to… 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) ... date on the latest global regulations. + Collaborate closely with the Quality, Regulatory , R&D, Business Development, Medical & Scientific Affairs , IT, and… more
- Sanofi Group (Cambridge, MA)
- …understanding of the scientific and medical value of our products in the therapeutic area and gather new insights by b** **ringing cutting edge scientific exchange ... + Exhibit a high degree of scientific and clinical knowledge in the therapeutic field to help identify and critically assess research opportunities and to play… more
- Randstad US (Cambridge, MA)
- …+ Knowledge of pharmaceutical industry and Project management experience within Medical Affairs , Clinical Research, Regulatory , CMC, Marketing or other drug ... usa - program manager - business professional. + cambridge , massachusetts...program level budgets across multiple projects + Knowledge of regulatory and compliance guidelines governing medical affairs … more
- Takeda Pharmaceuticals (Boston, MA)
- …skills. + Demonstrated understanding of compliance, ethical, legal, and regulatory guidelines impacting the pharmaceutical industry, Medical Affairs , ... true to the best of my knowledge. **Job Description** **About the role:** The Senior Manager US Field Medical Excellence Operations will serve as a key member of the… 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) ... Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more
- J&J Family of Companies (Manchester, NH)
- Senior MSL--ME, NH- VT-MA-RI - 2406187528W **Description** Janssen Scientific Affairs , LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a ... staying abreast of current scientific and treatment landscape trends in the relevant therapeutic areas and providing research support for the company as well as… more
- Sanofi Group (Boston, MA)
- …understanding of the scientific and medical value of our products in the therapeutic area and gather new insights by bringing cutting edge scientific exchange today ... our products. + Keep abreast of medical and scientific developments in the therapeutic field to help identify and critically assess research opportunities and to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …such as Supply Chain Management (SCM), Service, Sales, Market Quality, and Regulatory Affairs to achieve organizational objectives. **Job Duties** + Develop ... Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) more
- Editas Medicine (Cambridge, MA)
- …the clinical pipeline. The incumbent is expected to have a strong clinical, regulatory and scientific foundation, and will work closely with the cross functional ... will work across a matrixed organization with Research, Clinical Operations, Regulatory , Biometrics and other functions to ensure integrated development strategies.… more
- Sanofi Group (Cambridge, MA)
- …Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' ... with external stakeholders to enhance the understanding of the therapeutic area and medical value of our products. +...plans. + Co-create/develop Country Medical Plans (with TA Medical Manager , Medical Director or MSL Head) and lead team… 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) ... projects with cross-functional teams. + Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485. + Experience in audit… more