- Fresenius Medical Center (Waltham, MA)
- …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
- Philips (Cambridge, MA)
- ** Senior Regulatory Affairs Manager (US Hub based location)** The Senior Regulatory Affairs Manager will develop and communicate a vision for the ... strategy in the area of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and sustaining programs for Philips… more
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... 32 **Work Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory ...Center (BIDMC). The position is flexible in terms of remote versus onsite work. A part-time opportunity is available.… 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
- 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
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Orchard Therapeutics (Boston, MA)
- …Affairs Location: United States, ideally Boston or East Coast Job Summary The Senior Director, Medical Affairs will be a leadership role, accountable for ... Medical Affairs strategy, Medical Excellence, and field team execution for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT)… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …and community events either separately or in conjunction with the Public Affairs Office. Displays knowledge of Department priorities and mission statements to ... veteran organization, and community organization meetings with facility and regional senior leader staff members. Reviews and reports on policies in preparation… more
- Veterans Affairs, Veterans Health Administration (Brockton, MA)
- …The incumbent holds primary responsibility for preparing the unit for accreditation, regulatory , and safety reviews. The incumbent looks for opportunities within the ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019… more
- Merck (Boston, MA)
- **Job Description** The Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the ... with key opinion leaders of diverse expertise and backgrounds, and assist medical affairs in developing and guiding advisory boards + Represent our company's Animal… more
- Merck (Boston, MA)
- …as needed. + Works in partnership with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... **Job Description** With support of Sr CRA/CRA and/or CRA Manager, acts as primary...inputs on site selection and validation activities. + Performs remote and on-site monitoring & oversight activities using various… more
- Commonwealth Care Alliance (Boston, MA)
- …including budget development, staff resource allocation and shaping the overall Regulatory Affairs Compliance infrastructure. + Promote compliance in CCA's ... day compliance activities across the organization. + Serve as Regulatory Affairs and Compliance liaison with key...in meetings and to communicate with team members and senior leadership + Requires excellent interpersonal skills in order… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more
- Harvard University (Cambridge, MA)
- …Manager Department Office Location:USA - MA - Cambridge Business Title: Senior Director of Compliance for Strategic Research InitiativesSub-Unit:Office of the ... + Thorough understanding of a broad spectrum of the regulatory and policy requirements related to research administration and...a hybrid workplace model which will actively support some remote work. Specific days and schedules for on campus… more
- Takeda Pharmaceuticals (Boston, MA)
- …skills. + Demonstrated understanding of compliance, ethical, legal, and regulatory guidelines impacting the pharmaceutical industry, Medical Affairs , ... is 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… more
- Bristol Myers Squibb (Boston, MA)
- …child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. **\#LI- Remote , #** **BMSNEURO** _If you come across a role ... . Reporting into the Medical Value Liaison Field Director, the Senior Medical Value Liaison (MVL)/Executive MVL is a field-based role focused… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in Lexington, MA with the following requirements: Bachelor's degree in Clinical, Regulatory Affairs , Pharmacy, or related field or foreign academic equivalent ... vulnerable points in the PV domain. Up to 10% travel required. Up to 100% remote work allowed from anywhere in the US Full time. $195,458 - $223,200 per year.… more
- Takeda Pharmaceuticals (Boston, MA)
- …sales, regulatory , legal, I&A, commercial operations, patient advocacy, medical affairs , and patient value and access. + Management of the product lifecycle. ... functional alignment + Experience with representing the commercial perspective during the regulatory / legal / compliance review (USRC) of promotional materials and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …development into the launch timeframe. You will be part of US Medical Affairs and is responsible for developing and executing health economics and outcomes research ... multiple therapeutic areas and multiple timepoints of development. You will report to the Sr . Director, Outcomes Research - NPP. This is a hybrid role based in… more
- Sanofi Group (Cambridge, MA)
- …appropriate communication and collaboration among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining ... full compliance with relevant company, industry, legal and regulatory requirements + Demonstrate operational understanding and risk management by ensuring excellence… more