- 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)
- …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)
- …, 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)
- …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)
- …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)
- …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
- 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
- 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)
- …This leader plays a critical part in designing and driving the core risk management operations of the E&C team, ensuring the identification, assessment, and ... to support CECO reporting to internal and external stakeholders Oversees the management and enhancement of the technology and data analytics tools/systems… more
- Genmab (Plainsboro, NJ)
- …executiveOncology sales, marketing, or consulting within the biopharmaceutical industry.Project management in commercial operations .Experience leading teams and ... and growing organization? At Genmab, we're seeking a Senior Director , Strategic Planning & Effectiveness to drive cross-functional communication, alignment… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and assign accountability for managing ethics and compliance risks throughout NNI's operations Reviews data analytics reports for risks and trends Supports ... strategic risk mitigation efforts in alignment with the E&C's risk assessment, management and mitigation program. The Business Partner is responsible for regularly… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position Reporting to the head of Clinical, medical, Regulatory (CMR) Business Operations , the Associate Director (AD) is responsible for structuring ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...(SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and foster a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and ... input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And...in compliance and meets Novo Nordisk's business standards Risk Management : Assessing and mitigating risks associated with operations… more
