- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight . This role fulfills the PV Oversight for NNI Patient ... Relationship Reports to head of North America Operations Quality Pharmacovigilance Oversight . Maintains positive rapport and working relationships within and across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight . This role fulfills the PV Oversight function in PV ... to ie team members. Relationships Reports to head of NAO Quality PV Oversight Vendor Assessment Team and is an individual contributor role. Maintains positive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management. This role fulfills the PV Oversight ... to ie team members. Relationships Reports to head of NAO Quality PV Oversight . Maintains positive rapport and working relationships within and across departments in… more
- 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
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …to design an overall talent strategy to achieve research goals.Resource Oversight : Manage budgets, timelines and resource allocation with precision to ensure ... Federal Government research opportunities to develop additional revenue streams.Regulatory Oversight : Uphold the highest standards of quality and compliance with… 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
- 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
- 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. (Rahway, NJ)
- …the site BAS and HVAC control systems. Manage the development and oversight of site operations through data analytics.Establish and monitor key performance ... indicators (KPIs) for HVAC system reliability, energy efficiency, and compliance.Lead root cause analysis and corrective/preventive actions (CAPA) related to HVAC system failures or deviations.Monitor and ensure environmental compliance, HVAC system… more
- Merck & Co. (Rahway, NJ)
- …robust DS strategies for successful commercialization. Provide technical oversight of cell culture process development, process characterization and ... regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.Technical leadership: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large… more
- Merck & Co. (Rahway, NJ)
- …with contract manufacturer's production plan. Materials Management (ERP transactions, Logistics) Oversight of shop floor production (determining when an ExM ... functional rep should be deployed to the contract manufacturer's facility)Continuous Improvement activitiesPartners with Procurement in the Identification/Selection of new contract manufacturers and Negotiation/Termination of Supply Agreements, as… 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
- 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
- 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