- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV /MA Quality) and in close collaboration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to… more
- Tris Pharma (Monmouth Junction, NJ)
- …and inspection readiness of Drug Safety team at all times; Ensures internal regulatory / PV processes and procedures are well documented and support compliant ... regulatory / PV activities Reviews safety data exchange and/or ...with appropriate business partners and assumes accountability in ensuring compliance with safety data exchange activities Reviews and/or contributes… more
- Taiho Oncology (Princeton, NJ)
- …outside of Taiho (such as Business partners). + Effectively manage to ensure compliance with regulatory submissions and internal timelines. + Participate in ... Associate Director, PV Sciences Pleasanton, CA, USA * Princeton, NJ,...preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members. + Maintain… more
- Merck (North Wales, PA)
- …for CLIC. Maintains up-to-date awareness of biomedical literature, copyright compliance , adverse event reporting, and information storage and retrieval systems. ... to ensure optimum performance, reliability, data integrity, security, and copyright compliance . Directs the development, maintenance, and control activities of CLIC… more
- J&J Family of Companies (Titusville, NJ)
- …(QPPV), Senior Management, Health Authorities (HA), prescribers and/or patients. In compliance with legal and regulatory requirements, the MSO will ... the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans + Able to plan work to… more
- Sanofi Group (Trenton, NJ)
- …provide scientific support for internal functions such as commercial, market access, regulatory / PV and R&D regarding scientific trainings and updates. Training/ ... medical plan. + All MSLs comply with the local and corporate compliance frameworks for external and internal interactions and complete all global/local mandatory… more
- Sanofi Group (Trenton, NJ)
- …scientific support for internal functions such as commercial, market access, regulatory / PV and R&D regarding scientific trainings and updates **Supporting ... internal stakeholders. + All MSLs comply with the local and corporate compliance frameworks for external and internal interactions and complete all global/local… more
- J&J Family of Companies (Horsham, PA)
- …the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed ... stakeholders and minimal revisions required. * Provide input and review of key regulatory or clinical documents as appropriate. * Demonstrate leadership in the SMT… more
- Sargent & Lundy (Hamilton, NJ)
- …support industry-leading projects in power generation, plant design, environmental compliance , mid/downstream oil & gas, and multi-disciplined industrial projects. ... Our EIG teams perform detailed engineering services for photovoltaic ( PV ) solar projects and the integration of solar and...design and environmental permits from a wide variety of regulatory agencies. + Proficiency with one or more of… more
