- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation ... will have a strong background in documentation management, process oversight , and regulatory compliance within the pharmaceutical or biotechnology industry.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position The Manager - Technical Complaints Call Center Oversight is responsible for overseeing the initial evaluation of technical complaints for ... on more complex cases that require advanced assessment / decision-making Oversight and ensure adherence to required timelines Manage escalations from Technical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …leader for the role of GxP Patient Safety, Compliance & Vendor Oversight within our Clinical, Medical & Regulatory (CMR) organization. This position combines ... functions of patient safety training, compliance curriculum management, and vendor oversight to ensure adherence to regulatory standards while enhancing our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). Provides managerial ... oversight to colleagues that they are directly line managing...meeting required study deliverables including but not limited to oversight of CROs and Vendors and (as applicable) properly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are PV relevant and AE reporting language ... with CROs, License Partners, and PV vendors. Provide PV oversight of the DSI Call Center. Provide oversight... oversight of the DSI Call Center. Provide oversight of ICSR processing activities including, Safety Information submission… more
- Genmab (NJ)
- …our sites.Additionally, the Manager may also support on-site and/or remote trial oversight activities (within a region upon request). If regional-level oversight ... issues and risks in partnership with cross-functional trial teams. Supports requested oversight reviews (as applicable), CAPA and audits / inspections for site-based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position To ensure oversight and management of all contract and vendor related activities in Patient Safety ... and corporate goals Manages Patient Safety's responsibilities and maintains oversight toward Patient Support Programs (PSP), Market Research Programs (MRP),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The role also involves ... oversight of Vendors and management of ICSR Verification teams,...in relation to department objectives. Essential Functions Leadership & Oversight Lead and manage the global Case Processing team,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for ... to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents… more
- Aequor (Thousand Oaks, CA)
- …training. The position supports commercial drug substance production and requires cleanroom oversight , batch record review, and acting as a QA liaison during ... '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)
- …to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the ... and maintain a monitoring review spreadsheet.Compile and maintain CRO Oversight Monitoring (CROOM) visit outputAnalyze study site metrics reports to… more
- BioAgilytix (Boston, MA)
- …encompass strategic management, efficient operation, and meticulous procedural oversight of the archival function, including the seamless integration ... and oversight of external vendors to optimize the archival process and maintain the highest quality standards.Essential ResponsibilitiesReviews archival submissions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of ... encountered at the department level.- Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership… more
- Eisai, Inc (Nutley, NJ)
- …Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. This role is responsible for ... role is responsible for leading the digital transformation to enhance current quality oversight capabilities and knowledge within CQA and Eisai. This is a high… more
- Merck & Co. (North Wales, PA)
- …Clinical Director is responsible for protocol development and medical/ scientific oversight of clinical research studies involving new or marketed drugs in ... all phases of the trial process, including but not limited to the design, oversight and medical monitoring of Phase I to V clinical trials, preparation of progress… more
- Aequor (Thousand Oaks, CA)
- …will support the quality management system team to provide proactive compliance oversight to processes, functional areas and partner groups within the Corporate ... (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations Manages and provides oversight of documents / records within the Quality Management System Oversight … more
- Eisai, Inc (NJ)
- …collaborations with academic institutions, consortia, and technology partners.Provide oversight of imaging core laboratory activities, including the review ... documents-including the PCS, protocol, ICF, CRFs, SAP, TLGs, and CSR.Provide oversight of scan reconciliation and issue resolution in collaboration with imaging… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports directly to Head of PV Case Management. This role involves the oversight of case handling activities across the locations. Collaborate with the other ... closely with Promotional Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team, fostering a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …roles also serves as the subject matter expert in providing guidance, oversight and project management of assigned projects in Patient Safety. Relationship Reports ... Patient Safety Case Management. This role involves the case handling and oversight of activities across the locations. Collaborate with the other departments within… more
