- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory ... to be a part of our Global Regulatory Affairs organization.In this role, you will work in...role, you will work in close collaboration with the Global Regulatory Lead(s) on a compound in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT)… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Merck & Co. (Rahway, NJ)
- …competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized ... to customers worldwide. We are seeking a talented individual to join the team as Global Marketing Director to focus on expanding and growing our product, the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Associate Principal Scientist/ Associate Director , Outcomes ResearchRole SummaryUnder the guidance of a senior leader, an Associate ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- …relationships with contract manufacturing organizations, Negotiation of site and global Technical and Quality Agreements, Participating in contractor GMP audits ... the resolution of issues affecting quality and efficiency. Interpreting complex regulatory requirements for various audiences, including source area management, and… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key of our company's functions.Lead the… more
- Merck & Co. (Rahway, NJ)
- …breakthrough science that radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology ... Job DescriptionOur company is a global health care leader with a diversified portfolio...of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. --Specifically, the Director … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research ... Laboratories portfolio of clinical trials.- Global Clinical Supply is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... while improving and protecting patient access to care. Reporting to the Associate Vice President, Human Health and Manufacturing Communications, the Executive … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …reputation while ensuring effective internal and external stakeholder engagement. The Executive Director will report to the Associate Vice President, Human ... Job DescriptionThe Executive Director , our Company's Manufacturing Division Communications, is responsible...for the company's worldwide manufacturing organization, which spans a global network of sites for pharmaceuticals, vaccines, biologics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing Group to identify process… more
- Merck & Co. (Rahway, NJ)
- …(Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing ... the indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
