- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stages of commercialization.- For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs ... Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... supports oversight and management of integrations solution design, implementation strategy and requirements gathering, and technical feasibility and delivery. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, ... disciplines within the Daiichi Sankyo organization to obtain and/or provide information/ data for regulatory filings.Strategize and plan for FDA meetings for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable, ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …demographics, enrollment, retention and protocol compliance for consistency with study strategy ; reviews emerging clinical data regularly; performs quality ... Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy Strategy : Drafts development plan under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree requiredCoding Certification - Certified MedDRA Coder (CMC) or equivalent preferred Experience :4+ years of clinical data management medical coding ... preferredMust have a strong understanding and utilization of medical terminology; experience in coding medical data (adverse events and concomitant medications)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic direction to Biostats Data Mgmt ... & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan;...patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …facilitation, and post-inspection-related activities under the supervision of the IMT Lead .Management Review: Collect the data and information needed to ... perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are...the delivery and execution of the Global R&D QA strategy , activities, and deliverables against the R&D Oncology and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are ... partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal Department and PV… more
- Merck & Co. (Rahway, NJ)
- …ideal candidate will lead a cross functional insights team that spans data science, market research, data strategy , and measurement.The preferred ... Job DescriptionThe Associate Director Data Science will be responsible for developing and...be an independent contributor as well as be a lead partner in helping to scope, design, and deliver… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Job SummaryThe position develops the global safety strategy , oversees risk management activities, and recruits and develops staffing for ... stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy : Provides input to multiple aspects of the ... May participate in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally … more
- Merck & Co. (Rahway, NJ)
- …with regional and local teams to support development and implementation of a sourcing strategy at a global level, leveraging a Supply Strategy Council (SSC) ... key initiative.In addition, the candidate will be responsible to establish and lead cross-functional teams through the sourcing process and to provide strategy… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company's Digital Strategy is founded on the need for efficient, reusable, and user-friendly technology solutions. The Enterprise Architecture ... (EA) team is helping to lead this transformation. Our vision is to provide strategic...the management and direction of our IT and business Strategy .- Develop strategies that maximize success in risky/complex projects.Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …strategy realization office to ensure a consistent engagement experience for HHDDA key stakeholders.Responsibilities will include:Stakeholder Analysis: identify ... lead the digital evolution, within their respective areas.Engagement strategy development: develop and implement stakeholder engagement strategies and plans… more
- Merck & Co. (Rahway, NJ)
- …Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications ... Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has primary responsibility for the… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include ... lead by example through past scientific / technical expertise). Experience in budget planning & management, establishing development strategies, and managing… more
- Merck & Co. (Rahway, NJ)
- …the development of new molecules and new technologies that shape drug delivery strategy across our companyExtensive experience with conventional and novel drug ... of the drug development processDemonstrated ability to independently design, execute and lead complex experiments and data analysisTrack record of working… more
