- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Lab Oversight Specialist role is an exempt level position with...an exempt level position with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for… more
- Fidelity Investments (Merrimack, NH)
- …TitleDirector, Asset Management Treasurers Office - Digital Asset Policy and Product Oversight The RoleAs the Director of Digital Asset Product Oversight , ... skillsKnowledge of operational risk management and internal controls, governance and oversight processesAbility to apply sound judgment to identify issues and risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quality Lead(s) (EPQLs), who are responsible for delivering and executing Quality Oversight aspects of our vendors and partners based on the outsourcing models ... Quality Lead(s) (BPQLs), who are responsible for delivering and executing Quality Oversight aspects of our internal (DSG) GQA and R&D business functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories in ... be responsible for the management of the QA Lab Oversight team and will oversee the reviewing and approving...validation / qualification/ transfers, and general compliance / quality oversight for the laboratories. This role will have direct… more
- Genmab (NJ)
- …Role:An Associate Director, Data Management is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning, ... and reliable clinical trial data. The Associate Director DM will provide oversight to ensure end-to-end data management consistency across the portfolio. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …potential risks to the study and propose mitigation plans. CRO and Quality Oversight :Responsible for oversight of all CROs utilized within their therapeutic ... Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling...and best-in-class procedures and SOP's related to clinical study oversight and execution.Work with TMF Operations to ensure a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Microsoft Project or equivalent.Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and ... of study team plan and milestones (eg protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.). The study team leader will ensure meeting logistics, agenda and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resources and will have responsibility for training, mentoring, work assignment and oversight of the group. This position reports to the Associate Director Data ... partnership with the study data managers. Ensure effective quality oversight on the requests submitted by DM and authorized...Expertise: Serve as a subject matter expert and provide oversight and technical support in the planning, setup, and… more
- Genmab (Plainsboro, NJ)
- …data ethics regulations and policies; and (ii) the implementation and oversight of Genmab's third-party privacy risk compliance function. Successful candidates will ... Genmab's third-party partners.Partner with cross-functional team to establish third-party oversight strategy and support ongoing management of third-party data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Job Summary: This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the ... the RBQM processes across Daiichi Sankyo compounds with a focus on oversight , lessons learned and inspection readiness.Lead assessment of training needs and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities Prior TMF experience required!- Reconcile the TMF document ... and maintain a monitoring review spreadsheet.Compile and maintain CRO Oversight Monitoring (CROOM) visit outputAnalyze study site metrics reports to… more
- Genmab (Plainsboro, NJ)
- …the US Sales & Marketing teams. Key areas include Congress management & oversight ; Speakers Bureau management & oversight ; Processing of commercial displays, ... responsibilities related to marketing & sales executionVendor management & oversight , performance evaluations & optimizationFinancial tracking & budget managementIdentify… more
- Merck & Co. (Rahway, NJ)
- …for serving as the quality representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of ... contractor performance reviews as the quality lead for the oversight platform,Supporting product development teams in outsourcing activities to enable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Direction, and Strategy: Is accountable for the management and oversight of all DM programming, reporting, and external data acquisition ... is available for use by clinical study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …needs of special projects or implementation of new programs. Provide oversight for cross-organizational working groups to ensure alignment. Essential Functions ... all POA and regional meetings Responsible for the continuous management and oversight of the Marketing budget, including vendors and suppliers, ensuring that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level technical projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and ... and Global IT functions at Daiichi Sankyo. As a trusted partner, provide oversight of technical and solutions architecture and design for the R&D IT portfolio… more
- Merck & Co. (Rahway, NJ)
- …to the executive team and leadership teams of business groups.Project Management Oversight : Provide oversight on project management efforts defined by the ... Associate Director, ensuring comprehensive project plans and timely updates to management.Monitoring and Evaluation of Initiatives: Evaluate the progress of strategic initiatives and facilitate alignment by providing insights and adjustments as… more
- Insmed Incorporated (San Diego, CA)
- …Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of manufacturing build up and operations at Insmed's gene therapy ... activitiesPerform ongoing review of batch records as part of product release, oversight of deviations and CAPAs, and ensuring appropriate communication of issues,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Operational Excellence provides strategic planning and operational management oversight of GOMA projects, activities, and budgets.The Director, Program Management ... communication Escalating issues in a timely manner Budget management and oversight of contract-to-purchase order (PO) process Facilitating key meetings (internal… more
- Merck & Co. (Rahway, NJ)
- …Chief of Staff. The Executive Director will also be responsible for the oversight of our company's Creative Studios, which supports creative activities across the ... for the Chief Communications and Public Affairs Officer.Manage and provide oversight of and insight into cross Corporate Affairs budgets; identify synergies… more
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