- Philips (Cambridge, MA)
- …role you have the opportunity to** Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory ... US and EU submissions, and ensuring timely and high-quality execution of all regulatory deliverables. **Your role:** + Serve as RA Representative on project teams,… more
- Philips (Cambridge, MA)
- …Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… 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 ... of regulatory submissions. You will manage a Regulatory Affairs team supporting various new and...to participate in our comprehensive Philips Total Rewards benefits program , which includes a generous PTO, 401k (up to… more
- Sanofi Group (Cambridge, MA)
- **Global Regulatory Affairs Lead (GRL)** **Mission statements** + The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for ... of relevant pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global), in early and… 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 strategies for supported clinical programs. This role also ensures Medical Affairs representation on cross-functional program teams, contributes to the… more
- ConvaTec (Lexington, MA)
- …constantly learn and grow while honing your strategic thinking skills Our successful Director/ Senior Manager Medical Affairs will be involved in all aspects of ... of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing &...technologies + Develop and lead a medical science liaison program in US and EU geographies + Close collaboration… 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
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- Summary Serves as a Graduate Healthcare Administrative Training Program (GHATP) Trainee functioning as a Health System Specialist in the Office of the Director at ... the coordination of daily office activities. This position is responsible for all program matters under the direction of the Medical Center Director that are… more
- Veterans Affairs, Veterans Health Administration (Brockton, MA)
- …an advanced level. Senior social workers typically practice in a major program area such as but not limited to: Polytrauma Rehabilitation Center or Polytrauma ... or other program areas of equivalent scope and complexity. The senior social worker may be assigned administrative responsibility for clinical program … more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** Specialty I&I Medical Affairs colleagues are experts with a deep knowledge of I&I medicines and the Inflammation & Immunology therapeutic area. I&I ... and I&I colleagues as partners. In Specialty I&I Medical Affairs , we provide our customers with accurate and clinically...benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead will report… more
- State of Massachusetts (Boston, MA)
- …for this role. **Job:** **Administrative Services* **Organization:** **Office of Consumer Affairs and Business Regulation* **Title:** * Senior Director of ... *_About the Organization:_* The Office of Consumer Affairs and Business Regulation (OCABR) is a state...oversees and supports the following: the Lemon Law Arbitration Program ; the Home Improvement Contractor (HIC) Program … more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed + May lead Health Authority...initiation + Ensure that regulatory messaging for regulatory submission documents is aligned with program … more
- Eversource Energy (Westwood, MA)
- …including Rate and Revenue Requirement staff in all regulated jurisdictions, Legal, Regulatory Affairs , Accounting, Engineering, etc\.\. + Handles preparation of ... Regulatory Projects with secondary direction from Directors and senior leadership withinthe Rates and Revenue Requirements organization based on projects… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... staying **True to Life.** **Job Description** Leads and directs regulatory compliance communications to ensure compliance of the Global...areas of compliance risk and present these risks to senior leadership at Olympus in a clear and concise… more
- Eversource Energy (Westwood, MA)
- …the first three months in the office\. Eversource is looking for a ** Senior Program Manager, Strategic Project Development, Transmission** located in **Hartford, ... and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop… more
- Eversource Energy (Westwood, MA)
- **Our Team** Eversource is looking for a ** Senior Program Manager, Strategic Project Development** located in **Hartford, CT** or **Westwood, MA** or **Hooksett, ... and budgets in the conceptual phase prior to execution + Interacts regularly with Regulatory Affairs , Environmental Affairs , and Energy Efficiency to develop… 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 (Lexington, MA)
- …information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) ... 2) medical and scientific slides housed in the Medical Affairs slide repository, and 3) other pertinent publications in...and issues at sales meetings to assure legal and regulatory compliance. + Conducts strategic assessment (gap analysis) of… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** + Reporting to the VP, Global Gastroenterology Medical Lead, the Senior Director, Gastroenterology (GI) and Biosimilars is an integral member of the ... Care GI Global Medical team. The GI and Biosimilaers Senior Medical Director will serve as an expert in...and Country medical teams, Global Clinical Development, Medical information, Regulatory , Safety, etc.) to develop and execute an effective… more
- Sanofi Group (Cambridge, MA)
- …management. + Significant experience in Medical Governance, Medical Quality, Pharmacovigilance, Regulatory Affairs , Medical Operations (at global and affiliate ... to patients with specific illnesses where treatment access is limited. **Global Senior Manager - Governance & Risk Management** sits within Specialty Care MAP… more