- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards, processes and infrastructure in RBQM. Accountable for selection and oversight of external vendors within technical scope. Will also be responsible ... for the internalization and oversight of the RBQM model. Collaboration and partnership with...3-way model for ongoing/near term new trials.- External Vendor Oversight : Manages higher-level negotiation with external vendors. Provides … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI contracts that are PV relevant and AE reporting language ... with CROs, License Partners, and PV vendors.Assist with PV oversight of the DSI Call Center.Manage oversight ...PV oversight of the DSI Call Center.Manage oversight of ICSR processing activities including, Safety Information submission… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer ... requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document… more
- Eisai, Inc (Nutley, NJ)
- …plans of the respective compounds as well as the clinical execution and oversight of the associated studies being conducted globally. The Executive Director will ... in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) and drug development Plans (DDP)… more
- Aequor (Thousand Oaks, CA)
- …who are proactive, able to work independently with minimal oversight , and comfortable escalating issues appropriately. Candidates seeking long-term opportunities ... 's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review, documentation reviews in collaboration with the ICSR management and CRO/Vendor oversight groups for case processing activities and reports to the Director of ... case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight : Acts as subject matter expert in ICSR standards,… 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
- Merck & Co. (Durham, NC)
- …Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture, assemble, and test ... mindset. Consistently deliver On-Time and In-Full - with First Pass Quality. Oversight and presence on the production floor at External Partner site(s). Maintain… more
- Eisai, Inc (Nutley, NJ)
- …phases.The VP of Global Clinical Operations is responsible for the management, oversight , and direction of the clinical operations function in the execution of ... plans established by IPTLs.Oversee the TMF department, ensuring the management, oversight , and direction of TMF across all business functions.Provide training and… more
- Merck & Co. (North Wales, PA)
- …and employee development. Additionally, the AVP may provide strategic oversight and sponsorship of departmental initiatives.The requirements for this role ... leadership and sponsorship in large-scale strategic initiatives.Primary Responsibilities:Provides strategic oversight for late-stage development statistical support in Oncology therapeutic… more
- Genmab (NJ)
- …a solid scientific foundation existsEnsure proper documentation of work doneKeep oversight and QC essential documents/data provided by vendorsEnsure trial related ... BiostatisticsReview and provide input to protocol and amendment developmentPerform vendor oversight according to applicable SOPsGive input to eCRF setup, edit… more
- Tris Pharma (Monmouth Junction, NJ)
- …warehousing, logistics, etc.) to ensure day to day management and oversight of company's supply chain, logistics and inventory levels across organization ... supplier performance and conduct regular business reviews; Provides guidance and oversight for new sourcing, contracts, service agreements and capital equipment… more
- Merck & Co. (Rahway, NJ)
- …Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides oversight and quality management of submission data standard deliverables for ... world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and… more
- Merck & Co. (Rahway, NJ)
- …Management (PLM), Project Management, Regulatory Interactions, Regulatory Oversight , Risk Management, Scientific Leadership, Stakeholder Management, Strategic ... Leadership-Preferred Skills:Job Posting End Date:08/26/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of master data and data integrity related to US Talent Acquisition. ... Acquisition on projects related to processes, mergers and acquisitions Provides oversight and direction on processes supported in US Talent Acquisition Ensures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and launch strategy with cross-functional stakeholders and marketing leadership Provides oversight to ensure development of innovative and compelling market shaping ... for pipeline and inline assets. Accountable for the ongoing management and oversight of allocated budget from local and central funding. Maximize revenue and… more
- Eisai, Inc (Nutley, NJ)
- …Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good ... Clinical Practice (GCP) oversight , and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies,… more
- Eisai, Inc (Exton, PA)
- …sets strategic directions and project priorities, providing scientific leadership and oversight and managing individual performance and cost center budgets. The ... trends.8. Oversee design, implementation, and commissioning of new technologies for manufacturing. Oversight of other areas within the facility may be added at the… more
- Eisai, Inc (Nutley, NJ)
- …expedite approval of pending registration and answers any questions. This includes oversight , guidance, and management of GRS teams responsible for large, late stage ... staff advice and guidance on regulatory issues, especially for US. Responsible for oversight and strategic planning of the meetings with FDA, EMA, PMDA. Provide… more
- Merck & Co. (Rahway, NJ)
- …approaches strategies in support of Global, Regional, and Country plans.Provide oversight of pricing proposals to ensure alignment with the Global Pricing ... Strategy and portfolio considerations.Partner closely with the cross functional teams including Product Development (PDT), Global Commercial (GCT), Outcomes Research, Medical Affairs, as well as regional and country teams to ensure patient access objectives… more
