- 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
- Merck (Boston, MA)
- **Job Description** **Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director of Medical Affairs (GDMA) for ... edge of therapeutic and patient care advances. + The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… 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
- Danaher Corporation (Boston, MA)
- …reimagine healthcare, one diagnosis at a time. You will be a part of the CCIA Clinical Affairs team and report to the Senior Manager Clinical Affairs who is ... tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly managing… 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
- J&J Family of Companies (Boston, MA)
- …team members for completeness, accuracy, and structure + Work closely with Regulatory Affairs , Analytical Development, API Process Development, Drug Product ... Senior Scientific Integrator, Regulatory CMC Dossier...CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a case-by-case… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The ** Senior Clinical Director ( Sr . Principal Scientist)**...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... ** Regulatory Strategist** + Location: Cambridge, MA + Remote Work: Hybrid + Job Type: Full Time **About...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. + May lead Health Authority… 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
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… 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
- 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
- Bristol Myers Squibb (Cambridge, MA)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. The Heme Translational Medicine ... translational development process * Proven track record of drug submissions, approvals, regulatory interactions and label negotiations + Proven ability to work with… more
- AbbVie (Cambridge, MA)
- …of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs . Must possess solid foundation of generally accepted ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Immunology and BD… more