- Philips (Cambridge, MA)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for ... the world. **Your role:** + Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies ... Term Incentive Plan for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is committed to equality of opportunity in… more
- Harvard University (Cambridge, MA)
- …by law.Job Summary:The Senior Manager for Intergovernmental Policy and Regulatory Affairs for Harvard Public Affairs and Communications (HPAC) ... Location:USA - MA - Cambridge Business Title: Senior Manager for Intergovernmental Policy and Regulatory AffairsSub-Unit:...Senior Manager for Intergovernmental Policy and Regulatory Affairs brings significant knowledge of state… more
- Philips (Cambridge, MA)
- The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips' Ambulatory Monitoring & Diagnostics (AM&D) products are ... and regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with Internal Stakeholders and collaborate with… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Clinical Scientist (CS) - Sr . Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine ... programs. In collaboration with Scientific Affairs (SA) / Clinical Epidemiology, Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible… 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 ... role:** You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR)... regulatory bodies. + Manage the pre-fair market value (FMV)… more
- Commonwealth Care Alliance (Boston, MA)
- …duties as assigned. **Secondary Responsibilities** + Contribute towards the overall Department Regulatory Affairs and Compliance infrastructure at CCA. + Promote ... performance indicators **Additional Responsibilities** + Support Corrective Action Plan (CAP) Manager in communicating on new and existing CAPs emerging from source… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** About the role: Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will serve ... potential issues. POSITION ACCOUNTABILITIES: + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager , Aggregate Safety Reporting in Cambridge, MA, where you will be ... Safety Teams (GSTs) and with functional areas (Epidemiology, Clinical Operations, Regulatory Affairs , Finance, Safety Statistics, etc.) contributing to aggregate… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental ... to patients worldwide. **How you will contribute:** + The Senior Director, Pharmaceutical Sciences (PS) Portfolio Leader is accountable...PS / R&D and the commercial organizations + The Sr . Director, PS Portfolio Leader is a member of… 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
- AbbVie (Waltham, MA)
- …products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- ThermoFisher Scientific (Waltham, MA)
- …consultants. + Collaborate closely with other departments including eg Quality, Medical Affairs , Regulatory , Finance, and Legal on issues and potential ... completing post-marketing studies globally (excluding Japan) in compliance with regulatory requirements. Plan, coordinate, and manage the selection and operations… more
- Integra LifeSciences (Boston, MA)
- …from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed to evaluate, analyze, ... to help improve outcomes. **SUMMARY** This position reports to the Plant Manager and is responsible for manufacturing engineering at the Integra Tissue Technologies… 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
- State of Massachusetts (Boston, MA)
- …education, engagement and issue escalation. Provide assistance to AFC/GAFC senior manager on provider and constituent affairs services to resolve program ... the appropriate OLTSS internal staff. Provide assistance to AFC/GAFC senior manager during program regulation and rate...units within the MassHealth, the Executive Office of Elder Affairs , and other agencies in the state government. Conduct… 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
- Dana-Farber Cancer Institute (Boston, MA)
- …of several Phase I, II, III PI-Initiated / Multi-Center oncology trials. + Assist senior manager (s) in the development of a project plan that serves as ... The CTO PI-Initiated Research Project Manager (CTO RPM) for Waldenstrom's Macoglobulinemia Think Tank...field is preferred. + Must have strong knowledge of regulatory affairs , research ethics and the responsible… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Project Manager will work independently under general supervision of a more senior manager within their disease group. This position may be responsible for ... of success in clinical research field is preferred. + Must have knowledge of regulatory affairs , research ethics and the responsible conduct of research. At… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Project Manager I will work independently under general supervision of a more senior manager within their disease group and or the Clinical Trials Office. ... The Research Project Manager (RPM) is responsible for assigned day-to-day coordination...research field is preferred. + Must have knowledge of regulatory affairs , research ethics and the responsible… more