- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This role directs and operationalizes NNI's Ethics & Compliance (E&C) risk management program by leading and managing four functional areas: ... a critical part in designing and driving the core risk management operations of the E&C team,...regulations and requirements within the pharmaceutical industry Experience with oversight of compliance training preferred Proven track record of… more
- Aequor (South San Francisco, CA)
- …strategies, provide processes and tools for oversight of the overall risk and issues management , and offer continuous knowledge sharing and improvement ... Leads and other RBQM workgroup members to develop and operationalize the integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... Partner Management responsibilities.ResponsibilitiesPV Agreements and Contracts:Leads PVA/SDEA Management and maintains oversight of PV relevant contracts.… more
- Merck & Co. (Rahway, NJ)
- …Material(s):Required Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... financial stewardship-by taking accountability for how the-Value-Team-leverages-the IT Investment Management Framework. This role will-utilize-portfolio-demand-and-fiscal management -tools to-monitor-and… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Measurement Analysis, Portfolio, Programme, and Project Support, Program Management , Risk Management , Stakeholder Relationship ... hierarchy both within and across organization.Candidate will join our Project Management Office (PMO) for one of our Company's Enterprise-wide Accelerate multiyear… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality.Support the oversight and management of CAPAs by tracking and following up on the ... for the development of relevant quality reports and outputs (JOC, QRB, QQRs, EMR).CAPA Management Support the oversight and management of QE-related CAPAs by… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …CPP/CQAs are defined and understood by engineering and incorporated into design and control functions. Risk Management - assures risk management decisions ... for overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing risk in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Lead. Responsible for safety governance/ oversight of Clinical Safety and risk management activities. Providing adequate and proper management of ... and immune disorders. Job SummaryThe position develops the global safety strategy, oversees risk management activities, and recruits and develops staffing for at… more
- Twist BioScience (South San Francisco, CA)
- …programs with the organization's objectives and execute roadmapsProvide guidance, assessment, and oversight on the governance of Change Management and System ... those relative to business technology integrationsPartner with control owners to perform management assessment of risk over internal controls and identify… more
- Merck & Co. (Rahway, NJ)
- …of-Comparator Management ensuring timely planning, sourcing and management of Non-Company Commercial Products supporting clinical trials. Oversight ... of all components sourcing activitiesClinical supply chain Expense Management & Analysis Oversight ensuring compliance with all of our company's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Support at Novo Nordisk is responsible for ensuring effective centralization and management of HR budgets, particularly for P&O initiatives. This role provides ... strategic fiscal oversight for HR events and projects, contributing to the...operations within the organization. By exercising financial prudence, identifying risk areas, and maintaining transparent reporting, the role supports… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …writing investigation reports, and facilitating corrective and preventive actions including:Provide management oversight for quality control, batch records, and ... material review board.Provide management oversight for all QMS documents and...21 CFR part 4, and all associated regulatory requirements.Drive risk management in design, validation, and ongoing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3 studies ... questions and answers safety questions (dose modifications, discontinuations, and management of adverse events)May participate in Site Initiation Visit (SIV)… more
- Genmab (Plainsboro, NJ)
- …across all clinical pharmacology and quantitative sciences operations including governance oversight , functional risk management , and resolution of ... relevant experienceProven performance in earlier role/comparable role including strategic oversight and strategic stakeholder management across levels internally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance, Medical Affairs, Translational ... level technical projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy… more
- Merck & Co. (North Wales, PA)
- …teams.Strong problem-solving and decision-making skills, with a proactive approach to risk management and issue resolution.Solid organizational and time ... a pivotal member of our Team at Animal Health Global Supplier Management (AH-GSM), where approximately 200 dedicated professionals work collaboratively to ensure the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Strategic Sourcing efforts through to final contract, including project management , supply analysis, supplier identification, risk mitigation, sourcing ... from Request for Proposal (RFP) to final contract. This position has direct oversight and accountability of Category leads to drive and execute sourcing activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …availablePerform work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and ... proceduresCoordinate, staff, prepare and support timely execution of shutdownsSupport oversight of IFM calibration outcomes; reviews CPI/KPI/GPI where applicableParticipate,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Statement of Works (SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR Organization. Additional ... of CMR strategy and industry trends to drive informed decision-making with management buy-in and timely action for optimal customer results Understands governance of… more
- Merck & Co. (Rahway, NJ)
- …and global functions such as infrastructure, engineering, system security, risk management , etc.Education Requirement:-Bachelor's degree in automation, ... support. Can learn new concepts quickly and work independently with minimal oversight and collaborate with large groups while supporting applications and systems as… more
