- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... Project Teams Provide cross-functional strategic direction and project leadership Secure line management input and alignment from Executive Director and Vice… more
- Merck & Co. (Rahway, NJ)
- …standards of reference data and chemical nomenclatureLeading nomenclature and reference data projects or other data management tasksFacilitating timely ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data... data standards (US and/or international)Experience with master data management systems, content, and processesExperience in… more
- Merck & Co. (NC)
- Job DescriptionRole SummaryThe Cardiovascular & Metabolism Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease ... Scientific Leaders (SLs). The role provides balanced, factual, scientific information about non- product areas of interest to the Company and replies to scientific… more
- Merck & Co. (Rahway, NJ)
- …Global Marketing Director to focus on expanding and growing our product , the first-and-only HIF2 inhibitor, as an impactful approach to cancer treatment.- ... commercial leadership and input in various settings such as product /asset development teams, Key Opinion Leader engagement execution, competitive strategy,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... will interface with Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer… more
- Merck & Co. (Rahway, NJ)
- …Summary Under the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... in their HTA submissions. The incumbent is expected to contribute to product development and marketing strategies throughout the lifecycle to ensure that … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Strategic ForecastingThe Associate Director , Strategic Forecasting Insights, will be responsible for developing strategic ... role will work extremely closely with other DD&A functions, including Market Research, Data Science, and Payer Analytics to build a strong perspective on the market… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Merck & Co. (Rahway, NJ)
- …and data governance.- Mature the company's delivery of information assets, leveraging product management practices to offer " Data Products" Contribute to ... our company's investments in digital. Reporting to the Senior Director of Information Architecture, this role will be a...a master data management strategy, including entity definition and ongoing sustainment.Collaborate with… more
- Merck & Co. (Rahway, NJ)
- …Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …these Information Architecture focus areas: Data Governance- Metadata, Master and Reference data management and strategy- Data Architecture- Data ... value capture and acceleration. It will collaborate closely with Data Management Services and Data ...Experience in at least two of the Core Information Management Domains ( Product , Research, Manufacturing).- Experience in… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areaProven ability to effectively influence company life cycle management and data generationUnderstanding of resourcing and budgetingCurrent ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...leaders and key decision makers. The EDMA partners with Product Development Team leaders and Global Brand leaders. They… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads...support of business objectives.Responsibilities:Preparation of new and updated Core Data Sheets, EU and US Documentation: As the project… more
- Merck & Co. (Rahway, NJ)
- …Expert, Conduct of contractor "deep dive" quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality ... lead for the oversight platform, Supporting product development teams in outsourcing activities to enable our diverse pipeline Serving as the bridge for quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are PV relevant and AE… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary: The Global Senior Director Medical Affairs (Sr GDMA), Hematology is responsible for driving the development and execution of the ... (Hematology) in key countries and regions. They are impactful members of Product Development Team (PDT) and sub-teams, and Global Human Health commercialization… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is ... for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an… more
- Genmab (Plainsboro, NJ)
- …Sheet and US Prescribing Information depending on the role for the assigned product Consult with senior management to develop and communicate regulatory ... and maintenance of US/global regulatory strategies (in line with Target Product Profile). For approved products, ensure that regulatory strategies throughout… more
