- Sanofi (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... Job Title: Development Scientific Director (DSD) Location: Cambridge, MA, About the Job...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… 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)
- …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)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... of all assigned programs/products as the internal expert on US Codes, guidance, and industry standards pertaining to prescription...GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,… more
- Bristol Myers Squibb (Cambridge, MA)
- …us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, ... to precision therapies. The position demands deep scientific and regulatory expertise ( US , EU, Canada, PMD, TGA...background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10… 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
- Evident Scientific (Needham, MA)
- …every day. **Let's inspire healthier lives, together.** This role bridges Clinical Affairs and US Regulatory Compliance, leading end-to-end clinical ... inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs -...supported by R&D and manufacturing centers in Japan, the United States , Germany, and China, with operations… more
- Beth Israel Lahey Health (Burlington, MA)
- …projects.** **Conduct basic observations, audits, and chart reviews under the guidance of Regulatory Affairs Director to identify areas for improvement.** ... Affairs Specialist works under the direction of the Director of Regulatory Affairs , collaborating...more, making a difference in patients' lives. Your skill and compassion can make us even stronger.** **Equal Opportunity… more
- GRAIL (Boston, MA)
- …position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, ... projects, including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs),… 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 (Framingham, 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …range or starting pay for individuals who are hired in the role to perform in the United States . Other elements may be used to determine actual pay such as the ... As a senior leader within Medical Affairs , the Executive Director will serve...organization. Serving as a key liaison across the Global, US , and Commercial ecosystem, the Executive Director … 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)
- **Job Description** The US Director of Medical Affairs (DMA) for Gynecologic Malignancies (Ovarian, Endometrial and Cervical Cancer) holds primary ... are not limited to** : + Develops and executes US Medical Affairs strategy for Gynecologic malignancies...interactions with Patient Advocacy Groups + Tracks guidelines and regulatory landscape in the US region +… 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
- CSL Behring (Waltham, MA)
- …CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director , Corporate & External Affairs , R&D Portfolio **Main ... **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager,...Responsibilities and Accountabilities:** + Support the Associate Director in serving as a business partner and advisor… more
- Chiesi (Boston, MA)
- …and tactics in the US under the guidance of the Senior Director of Global Medical Affairs HIDO. This includes initiating and maintaining relationships ... countries. More than 7,000 employees across the group are united by a singular purpose: promoting a healthier world...for Purpose The Lead role reports to the Senior Director of Global Medical Affairs HIDO and… more
