- Merck & Co. (Rahway, NJ)
- …The Executive Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls Organization (GRACS CMC), ... critical role in driving alignment and execution globally across Regulatory CMC, GRACS, our Research and Development ...across divisions/ business units and in the external business and regulatory environment to identify potential… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and China, and indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation ... these findings to relevant cross-functional stakeholders, to help inform future DS regulatory / development strategies, activities and ways of working. This role… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... for all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory… more
- Merck & Co. (North Wales, PA)
- …for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides ... of regulatory success together with risk mitigation measures.Lead the development , communication, and review of the CMC Regulatory Strategy Document… more
- Merck & Co. (North Wales, PA)
- …that meet business objectives and minimize regulatory risk-Provide regulatory consultation in the development and implementation of US marketing strategy ... Job DescriptionReports to the Director /Senior Director in the Office of...teams to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities Lead the ... advanced degree is strongly preferred Minimum of 10 years drug development /FDA/ regulatory related industry experience required Demonstrated knowledge of global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, North America Clinical Development (NACD) Clinical Medical & Regulatory (CMR), Future Business Strategy (FBS), Strategic Operations (SO, Human ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development… more
- Eisai, Inc (Nutley, NJ)
- …messaging, and execution within scope of projects. Actively contribute to the development of the annual business plan. Requirements Bachelor's degree (BS/BA) ... and oncology, with a strong emphasis on research and development . Our history includes the development of...profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the… more
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation and ... and oncology, with a strong emphasis on research and development . Our history includes the development of...profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical… more
- Merck & Co. (Rahway, NJ)
- …with cross-functional partners including research and development , medical affairs, regulatory affairs, manufacturing, business development & licensing, ... and market researchSupport forecasts for new study recommendations and/or business development activitiesDevelop Global Guidance for market forecasts… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , 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… more
- Eisai, Inc (Nutley, NJ)
- …communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development , planning, implementation, and ... and oncology, with a strong emphasis on research and development . Our history includes the development of...profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR), staying up-to-date… more
- Eisai, Inc (NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the… more
- Merck & Co. (Rahway, NJ)
- …clinical development plan and Investigational New Drug applications;Providing clinical development support of business development assessments of ... record of scientific scholarship and achievementPrior experience in working with business development to assess external assets preferredStrong interpersonal… more
- Tris Pharma (Monmouth Junction, NJ)
- …Clinical Research Organizations (CROs) and vendors across all phases of drug development ; Ensures compliance with established clinical and regulatory guidelines, ... Clinical Operations and Project Management areas ensuring ability to meet clinical, regulatory and business objectives through efficient completion of delegated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… 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
