- Merck & Co. (Rahway, NJ)
- …and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory ... Job DescriptionOur Regulatory Affairs team bring new medical...committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... for someone with a growth mindset.Position Description: The Senior Director , Global Regulatory Lead, is responsible for... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Title - Principal ScientistDepartment- Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious DiseaseBrief Description of ... PositionThe Regulatory Affairs Headquarters Principal Scientist is responsible...charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.Conducts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.- Partner and collaborate with Clinical Operations, Biostatistics and Data Management, Regulatory Affairs and other RD functions to ensure effective ... within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and size… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... visible expert leader, he/she will engage the clinical, Medical Affairs and commercial organization and drive the product evidence...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,)...to deliver on GLP/GCLP commitments that are pivotal to early phase submissions.Collaborate with Global QMS to build a… more
- Merck & Co. (Rahway, NJ)
- …internal partners including HH, our Research & Development Division , Medical Affairs , Market Access, Regulatory Affairs , Legal & Compliance, ... and pharma?Then you could be our new Global Marketing Director , Precision Medicine.The position: We are currently recruiting for...to support our growing portfolio of Oncology Medicines across early stage of the diseases.- The development of tumor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key… more
- Merck & Co. (Rahway, NJ)
- …studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs ( Early Development) provides strategic ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical ( Early Development), may be called upon ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...+ procedural cross-functional teams. + Assigns reports to represent early - and late-stage project teams and ensures timely and… more
- AbbVie (North Chicago, IL)
- …defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical Affairs Quality Standards ... responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs...assurance excellence mindset. The role reports to the Senior Director of Safety, Vigilance and Medical Affairs … more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader (General ... time for a career you can be proud of. ** Regulatory Affairs Director - Global...ambiguity + Negotiation skills + Global Regulatory Affairs experience + Biological product experience + Early… more
- Schrodinger (Cambridge, MA)
- We're seeking an **Associate Director of Regulatory Affairs ** with expertise in hematology and oncology to join our Early Clinical Development team in ... or Cambridge, MA. This hire will report to the Director of Regulatory Affairs and... and will play an essential role in the regulatory activities of global oncology trials in early… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make a ... expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where...years of pharmaceutical industry experience in developing and implementing regulatory submissions strategy for early and late… more
- Merck (North Wales, PA)
- …and solutions to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing ... **Job Description** Our Regulatory Affairs team bring new medical...committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early… more
- Merck (North Wales, PA)
- **Job Description** **Position Title** - Principal Scientist **Department** - Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease ... **Brief Description of Position** The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global … more
- Merck (Rahway, NJ)
- **Job Description** Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, ... someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and… more
