- Merck & Co. (Rockville, MD)
- Job DescriptionThe Global Regulatory Policy & Intelligence (GRPI) team advocates for regulatory policy that supports our company's business goals, ... the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS)...the company's enterprise policy agenda.Responsibilities of the Director , US Regulatory Policy , will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and ... USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy teamLeads day-to-day a team of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development ... Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global Customer Marketing and Commercial Execution to ensure optimized and successful… more
- Merck & Co. (Rahway, NJ)
- …engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and ... Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to...input on such activities as:target product profile (TPP) development, global regulatory filing strategy, launch readiness reviews,… more
- Merck & Co. (Rahway, NJ)
- …commercialization, including product development team, target product profile development, global regulatory filing strategy, launch readiness reviews, organized ... Job DescriptionWe have an exciting Director opportunity to join our global ... brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Oncology Communications The role of Director , Global Communications, Oncology is a unique opportunity to join our Company, a ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Merck & Co. (Washington, DC)
- …federal legislative and regulatory activities and initiatives.- The Associate Director will also represent our Company at policy -related external events ... Job DescriptionPosition Description: Associate Director , Federal Policy and Government Relations...limited to: Research and provide analysis of federal legislation, regulatory proposals, government data, third party stakeholder activities, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …side) CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in the external environment and ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …comprehensive and current understanding of relevant healthcare environment matters including policy , regulatory , health technology to identify key issues ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …endpoints including proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in ... Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director . QP2-IO team is part of the Global...methods. Experience in IND, NDA and other submissions to global regulatory agencies. Skills in experimental design,… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, develops, and ... and design history file development.Remain current in relevant worldwide regulatory guidance and standards.Proactively resolve project obstacles and challenges and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …coaching/guidance to individual contributors. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of ... our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or Late Drug Development… more
- Merck & Co. (Rahway, NJ)
- …understanding of relevant healthcare environment matters, including policy , regulatory , and health technology.Developing a global internal network of ... cancer patients globally.We are currently seeking an Oncology Competitive Intelligence Director specializing in Women's Cancers. This role is responsible for… more
- Merck & Co. (North Wales, PA)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
