- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Boston, MA)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific oversight… more
- CSL Behring (Waltham, MA)
- …approval in one key region (EU, US , Japan) -Experience working in Regulatory Affairs with agency interaction responsibility with at least 1 health authority. ... (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA… more
- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek...cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities… more
- Sumitomo Pharma (Boston, MA)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US ....I-IV Research & Development Activities + As a Regional Regulatory Lead, manage regional ( United States… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US ....mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional ( United States… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs...different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic ... and operational oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer… more
- Takeda Pharmaceuticals (Boston, MA)
- …area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products as ... GRA CMC Product Lead. + Represents and contributes to Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical development and… more
- Beth Israel Lahey Health (Boston, MA)
- …Summary: The Regulatory and Accreditation Program Manager reports to the Director , Regulatory Affairs . Manages the accreditation/ regulatory program ... management support. Coordinates the dissemination of performance assessment and regulatory updates to appropriate medical center staff. + Ensures that… more
- Cardinal Health (Boston, MA)
- …joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across ... medical discipline in applicable field highly preferred + Current working knowledge of US legal, regulatory , and compliance regulations & guidelines to industry… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …best of my knowledge. **Job Description** **About the role:** Join Takeda as the Senior Director , US Medical Affairs - Head of Rheumatology in Cambridge, MA. ... This is a critical role within the US Medical Affairs (USMA) organization that reports...coaching/mentorship to team managers, as appropriate. Further, the Senior Director will contribute to the medical unit insights, including… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as the Medical Affairs Senior Director , Oncology - Colorectal Cancer. You will champion new ... products and on Takeda therapeutics positioned in the disease states . Maintain and continue to build the highest level...to Takeda. You will report to the Head of US OBU Medical Affairs and the role… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us :** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...address highest unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs (GMA) based… more
- Merck (Boston, MA)
- …as a resource for the PM MAD-HSO Team Lead, HSO Executive Director Medical Affairs , and other members of US Medical Affairs on other relevant strategic ... **Job Description** + The Precision Medicine - Medical Affairs Director - Health Systems Oncology...in a balanced and credible manner consistent with the regulatory environment and the company's ethical standards. This role… more
- Takeda Pharmaceuticals (Boston, MA)
- …and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Hematology. ... development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead, Hematology** proactively defines and drives… more
- Wolters Kluwer (Waltham, MA)
- …nurses, accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. We help professionals deliver deep impact when it matters ... our key internal and external stakeholders, is seeking a Director , Executive Communications, to support the health division, based...Communications, to support the health division, based in the US This position will report to the Vice President,… more
