- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the submission dossier, where applicable, and to ensure timelines and business objectives are met. Subject matter expert ( SME ) in 2 or more focus ... (DMCs) and due diligence activities for assigned product(s), as neededActs as audit/inspection Subject Matter Expert ( SME ) for safety surveillance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …some of the requirements of this role. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to ... rather than updating or changing existing standards.Serve as the subject matter expert from Data...standards for assigned DS Program / Studies by employing subject matter expertise. Ensures modern core… more
- Merck & Co. (Rahway, NJ)
- … areas to lead the development of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug delivery and/or ... an enterprise levelStrong mentoring capabilities to build individuals and teamsRecognized as a subject matter expert in multiple drug delivery and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert ( SME ) for internal audit ... demonstrated decision-making capabilities Provides medical and scientific expertise to cross- functional DSI colleagues.Responsibilities:Medical Monitoring:For studies in which Medical Monitoring… more
- Merck & Co. (Rahway, NJ)
- …and performance management.May serve as a subject matter expert and/or participate on process improvement teams. Core SkillsDemonstrated ability to drive ... execution of Phase 1-4 clinical studies. Under the direction of the Program Lead , you will collaborate with global, cross- functional team members including… more
- Merck & Co. (Rahway, NJ)
- …and performance management.May serve as a subject matter expert and/or participate on process improvement teams. Core Skills: This position may ... 1-4 clinical studies. Under the direction of the Program Lead , you will collaborate with global, cross - functional... Lead , you will collaborate with global, cross - functional team members including clinical directors and study managers… more
- Merck & Co. (North Wales, PA)
- …launch plans while leveraging agile strategies and methods.Serve as a launch excellence subject matter expert .Bring novel ideas to launch readiness across ... plans aligns with brand strategy.Track progress and identify risks and cross- functional interdependencies across all launch workstreams. Lead scenario planning,… more
- Genmab (Plainsboro, NJ)
- …and leading the USMA team for the solid tumor portfolio. They will be the subject matter expert responsible for leading the development and execution of ... the execution of tactics, working in close collaboration with cross functional matrix colleaguesAccountable for ensuring USMA launch readiness (for solid tumor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health ... demonstrated decision-making capabilities Provides medical and scientific expertise to cross- functional DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health ... demonstrated decision-making capabilities. Provides medical and scientific expertise to cross- functional DSI colleagues.Responsibilities:Medical Monitoring:For studies in which Medical Monitoring… more
