- 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
- ThermoFisher Scientific (Waltham, MA)
- …will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as ... services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and… 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
- Medtronic (Boston, MA)
- …to innovation in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Program Manager will manage implementation regulatory ... Robotics Surgical Technologies (RST) portfolio. The mission of Global Regulatory Affairs is to influence the ...computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions… 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
- Sumitomo Pharma (Boston, MA)
- …our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Senior Manager , Medical Strategy (Oncology) will be a key member ... of the Medical Affairs team reporting to the Executive Director, Medical ...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Commonwealth Care Alliance (Boston, MA)
- **Why This Role is Important to Us:** Under direction of the Sr . Director of Regulatory & External Audits, the primary focus areas of this position includes ... and resulting Corrective Action Plan (CAP). This includes audits from external regulatory agencies including but limited to Centers for Medicare & Medicaid Services… more
- Elevance Health (Woburn, MA)
- …and tactical issues. + Work collaboratively with other teams, including legal, compliance, regulatory affairs , in supporting the business. + In a complex and ... General Counsel Sr . - Pharmacy** will serve as an Associate General Counsel Sr . to CarelonRx, a pharmacy benefits manager (PBM) owned by Elevance Health.… more
- Commonwealth Care Alliance (Boston, MA)
- …Healthcare Compliance (CHC) preferred. + 5 or more years direct work experience in regulatory affairs and/or compliance in Medicare or Medicaid required + 5 or ... to regulators + Submit materials to regulators + Coordinate attestations from Senior Leadership for submission **Compliance Regulatory Guidance Distribution** +… 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
- Fresenius Medical Center (Waltham, MA)
- …policies and standards. Collaborates with other departments including the medical office, regulatory affairs , quality, and education as they assist in ... measures throughout the organization according to accepted standards and regulatory requirements. Responsible for maintaining records and preparing reports related… more
- Fresenius Medical Center (Waltham, MA)
- …can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… 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
- J&J Family of Companies (Cambridge, MA)
- Manager , Regulatory Program Manager ... Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, ... a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related discipline. Advanced degree preferred.… more
- GE Vernova (Cambridge, MA)
- …serve as a lead assessor of environmental risk for key strategic initiatives. This senior manager will work closely with team members from Environmental & ... serve as a lead assessor of environmental risk for key strategic initiatives. This senior manager will work closely with team members from Environmental &… more
- GE Vernova (Cambridge, MA)
- …operations manager for GE Vernova's portfolio of 100+ remedial projects. This senior manager will work closely with team members from Environmental & ... operations manager for GE Vernova's portfolio of 100+ remedial projects. This senior manager will work closely with team members from Environmental &… more
- Edwards Lifesciences (Boston, MA)
- …longer and healthier lives. Join us and be part of our inspiring journey. As ** Senior Manager , Biostatistics** , you are responsible for leading a team of ... products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion...prevention of pollution under their span of influence/control The Sr Manager , Biostatistics Level is lateral to… more
- embecta (Andover, MA)
- …to support the varying needs of our diverse and global employees. The Senior Manager , Systems Engineering will provide leadership to System Engineering ... R&D organization with a focus on architecture development. The Senior Manager will lead System Engineering team...peer leaders across R&D, Quality, Marketing, Clinical and Scientific Affairs , Operations, Medical Affairs and Regulatory… more