- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as ... and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems. Ensures the systems are appropriately configured and maintained. Manages the employee data management processes. Ensures the HR master data is ... needs of a company poised for continued growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,...clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Daiichi Sankyo Pharmacovigilance Safety systems, and fulfillment of data change requests. ResponsibilitiesChange Requests for PV Systems Collaborate cross ... Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations , while ensuring the highest level of qualityCollaborate with internal… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to Clinical Operations , Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to medical coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym list. Coordinate ... with Data Operations Team on coding dictionary set...company specific synonym list. Responsible for the filing of Data Management coding documentation and approval/signatures forms… more
- Merck & Co. (Rahway, NJ)
- …Position Description: The Office of General Counsel is seeking an Associate Director , Trademark Operations to provide docketing and legal operations ... building, recruiting, staff development, training, and mentorshipExperience in legal operations , including strategic planning, project management , financial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance of NNI ... in partnership with Legal, Compliance, Privacy and other critical functions. The Director will help integrate data and technological capabilities to drive… more
- Merck & Co. (Rahway, NJ)
- … Director , Insights & Analytics is responsible for leveraging data -driven insights and advanced analytics to shape communication strategies, enhance stakeholder ... support the company's overall business objectives.From our company's owned channel platform data to social conversations outside the company, there are many data… more
- Merck & Co. (Rahway, NJ)
- …complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations , will oversee laboratory compliance across multiple ... Job Description Job Description: The GMP Operations branch of Biologics Analytical Research & Development...audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well as… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …degree or equivalent required, MBA-preferred 10+ years of progressive brand management /marketing and/or sales/ operations experience required 5+ years of ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …areas through team of business partners. This includes ownership of P&L management and strategic resource allocation, on-going operations /reporting and for ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Qualifications Bachelor's degree or equivalent experience required 8+ years of operations , quality assurance, call center, compliance, project management , ... organization to guide enterprise-wide resource allocations, investment choices, drive core operations and develop insights to drive growth and operational excellence… more
- Genmab (Plainsboro, NJ)
- …equivalent.Experience in handling integration management , process and continuous improvement management , digital or data technology, operations , supply ... internal and external stakeholders, including GCDS Operations , GCDS Systems, Development Operations , Portfolio & Project Management , and CMC. You are skilled… more
