- 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 ... (MOC) program. + Active medical license. + Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs , clinical evidence… 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
- AbbVie (Waltham, MA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Abbott (Burlington, MA)
- …their health and get on with their lives. **THE OPPORTUNITY** **Scientific Communications Manager ** We have an exciting opportunity for the right candidate to join ... our growing clinical affairs team within Abbott Heart Failure. The job purpose...The job purpose and scope of the Scientific Communications Manager is to effectively communicate and proactively lead 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)
- … Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... timely completion of applicable Customer Quality commitments to US FDA, and other Regulatory Authorities as applicable. + Leads cross site / functional teams on… 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 ... likely not legitimate. **Job Description** The Global Lead of Respiratory Clinical Affairs reports directly to the Global Head of Clinical Research and collaborates… 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. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the...and support of audits and inspections. + Liaises with Regulatory Affairs to coordinate synchronization of aggregate… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental ... and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what… 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) ... regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements. + Responsible for reviewing complaint handling requests… 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
- 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) ... working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135,… more