- Sanofi Group (Bridgewater, NJ)
- …and Maintenance of** ** PV Operating &** **Safety Management System** In compliance with PV regulatory requirements and company procedures/guidelines, + ... activities in the assigned country are performed in compliance with the Global PV policies, as...CSH + PV Zone Leads + Regional PV Head + Country Medical/ Regulatory /Quality Teams and… more
- Sanofi Group (Bridgewater, NJ)
- …and other functions in compliance with global procedures and local regulatory PV requirements + To systematically evaluate the availability of resources ... Responsibilities** This is a Leadership member of the CHC PV Operations team and reports to the CHC ...procedures and systems in line with changes in the regulatory environment and best industry practices. + He/She is… more
- Sanofi Group (Bridgewater, NJ)
- …Consumer Health PV organization including Consumer Healthcare PV Operations, PV Affiliates, PV Compliance , Safety Signal & Risk Management, Global ... **CHC PV Data Strategy and Management Head** + _Location:...+ Conduct regular access management reviews to remain in compliance with corporate security policies. + Responsible for supporting… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …establish in-built controls in relevant process steps to ensure adherence to regulatory compliance . + Monitor effectiveness of implementation of applicable ... 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …development and maintenance, regulatory operations and filings-related activities including regulatory submissions, regulatory compliance , regulatory ... and review submission packages, labeling revisions, and promotional materials for regulatory compliance including supporting launch and market growth for… more
- US Tech Solutions (Raritan, NJ)
- …2 years of experience in pharmacovigilance case processing, aggregate reporting, and/or PV compliance monitoring. **About US Tech Solutions:** US Tech Solutions ... Sr. Associate, Aggregate Report Compliance Role can be 100% REMOTE - May...Working within the Global Environment / Global Teams - Regulatory Affairs experience - MAIN ASPECT OF ROLE: Support… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the data reporting requirement in accordance with SOPs, client requirements, and regulatory guidelines. This position will be responsible for development of SDTM, ... medical safety evaluation team, pharmacovigilance operation, case processing, quality, and compliance team to collect the requirement and improve the deliverables.… more
- Sanofi Group (Bridgewater, NJ)
- …of functional areas such as marketing, clinical development, pharmacovigilance and regulatory in compliance with law, ethical/scientific principles, and Group ... external partnership with communicable diseases experts/ health care agencies/ regulatory agencies/ institutions and medical/ scientific organizations. In addition,… more
- Sanofi Group (Bridgewater, NJ)
- …with other CRDs in the project, Global Project Head, Translational Medicine, PV , Regulatory and other key functional representatives **Key responsibilities ... management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well… more
- J&J Family of Companies (Raritan, NJ)
- …(QPPV) Pharma, Senior Management, Health Authorities (HA), Prescribers and/or Patients. In compliance with legal and regulatory requirements, the MSO will also ... 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and maintains the DSUR, PBRER and RMP development project schedules in compliance with global procedures and assigns deliverables to key identified stakeholders. + ... used to review and finalize key safety documents. + Mentors junior pharmacovigilance ( PV ) personnel in their functions. + Participate in the development of global… 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