- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The … 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... RA strategy into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as a… 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)
- …Animal Health Sites.Leads site EHS leaders and influences site, region, and global business partners to drive prioritization of regulatory compliance, continuous ... Job DescriptionOur Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global...with Market Research, Competitive Intelligence, Marketing, MA, R&D, Finance, Regulatory and Market Access internally across global … more
- Merck & Co. (Rahway, NJ)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director for the Integrated Logistics Procurement & Sourcing Organization will oversee a portfolio exceeding $750 million at a global ... supply of critical medicines through our supplier network while navigating diverse regulatory landscapes and country-specific routes to market.As a member of the… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. --Specifically, the Director may ... Job DescriptionOur company is a global health care leader with a diversified portfolio...radically changes the way we approach serious diseases. --The Director will report to an Associate Vice President in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... 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)
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Vaccines Communications is responsible for leading, developing and executing US and global communications strategies and ... Vice President, Human Health and Manufacturing Communications, the Executive Director , Vaccines Communications is responsible for the development of strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Associate Principal Scientist/Associate Director , Outcomes ResearchRole SummaryUnder the guidance of a senior leader, an Associate Principal ... Scientist/Associate Director , has primary responsibility for planning/managing real world and...Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be responsible for Evaluating pre-clinical and translational work for ... Job DescriptionOur company is a global health care leader with a diversified portfolio...while developing and expanding your career. - The Senior Director (Senior Principal Scientist) has primary responsibility for the… more
- Merck & Co. (Rahway, NJ)
- …modeling of tumor size and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... 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)
- …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
- Merck & Co. (Rahway, NJ)
- …endpoints including proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in ... - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global...Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin us as an Executive Director of Tax Planning to lead our tax strategy for the US and navigate the ever-evolving global tax landscape. This ... efforts, responsible for guiding our strategic vision, ensuring compliance with regulatory developments, and positioning the company for sustained growth and… more
