- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical ... and regional level), as well with other relevant internal stakeholders - early development teams, commercial, CORE, Scientific affairs , Market Access, among… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...of the enterprise, especially the transition of rising star early assets to late phase development, based on the… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for… 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. (North Wales, PA)
- …Leaders; and ensure all Scientific Leader engagement activities comply with regulatory , legal, and ethical standardsCommercial lead in driving engaging presence of ... across marketing or related experiences in pharmaceutical (ie medical affairs ) or biotechnology industriesDemonstrated ability to develop and execute Scientific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... well as HCP related strategies on KOL engagement and early market education. This role is responsible for the...life cycle activities Health Systems strategy: Collaborates with medical affairs and market access teams to inform a health… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry experience (including roles in research and development (R&D), clinical trials, regulatory affairs , or medical affairs Leadership Experience: Proven ... Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… 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)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may be called ... to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical...and procedural cross-functional teams. + Assigns reports to represent early - and late-stage project teams and ensures timely and… 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
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... international standards + Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA… more
- Lilly (Indianapolis, IN)
- …for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participatein forumsthatshareregulatoryinformationacrossGRA… more
- Lilly (Madison, WI)
- …our best effort to our work, and we put people first. The Senior Director is responsible for the development and implementation of Lilly's government affairs ... - Cardiometabolic Health, Immunology, Neuroscience, and Oncology. The Senior Director requires a combination of technical expertise and cross-functional leadership… more
- Lilly (Raleigh, NC)
- …life better for people around the world. **Job Description** The Senior Director is responsible for the development and implementation of Lilly's state government ... affairs strategy with tight coordination with our Business Units....within the enterprise and with external entities. The Senior Director must have the experience to lead large-scale projects… more
