- AbbVie (Florham Park, NJ)
- …responses and discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly… more
- Adecco US, Inc. (Clark, NJ)
- …preferred. + 3-5+ years of relevant experience in post-market safety, pharmacovigilance , cosmetovigilance, or related data-processing roles. + Experience with MedDRA ... terminology strongly preferred. + Understanding of US Post-Marketing Safety regulations (OTC and Cosmetic) is a plus. + Strong communication skills (written, verbal). + Highly organized with the ability to manage multiple tasks and deadlines simultaneously. +… more
- Ascendis Pharma (Princeton, NJ)
- …Legal, Regulatory, Clinical Development, Clinical Operations, Compliance, Pharmacovigilance , Biometrics, Global Communications, and other functional group ... contributors to support the US Medical Director in successful management of Medical Affairs projects. + Support the US Medical Director in the design and implement medical strategies and tactical plans while providing thought leadership for medical publication… more
- Datavant (Trenton, NJ)
- …CRO ecosystem. 19. Stay current on trends in clinical operations, pharmacovigilance , and commercialization to inform CRO partnership priorities. 20. Identify ... emerging CROs or adjacent partners to expand Datavant's ecosystem reach. **What You Need to Succeed** + 10+ years of experience in channel management, partnerships, or business development. + Experience in **healthcare technology** , **clinical research** ,… more
- Sanofi Group (Morristown, NJ)
- …(eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, Procurement etc ), ... responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …at all levels of the organization + Demonstrates an awareness of pharmacovigilance regulations and methodology + Demonstrates a solid understanding of scientific ... methodology in the design, conduct, interpretation and reporting of clinical research projects with emphasis on safety monitoring + History of working seamlessly with Clinical Operations Physical Requirements: + Some limited travel required Approximately 15%.… more
- Sanofi Group (Morristown, NJ)
- …benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team + Implements strategies to identify, ... monitor and resolve clinical program/trial issues. + Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data. + Provide appropriate medical input & support for all activities related to clinical studies… more
- Sanofi Group (Morristown, NJ)
- …(eg clinical operations, project management, Patient Safety and Pharmacovigilance , regulatory, Finance, Scientific External Engagement, Procurement etc.), ... responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures… more
- Sumitomo Pharma (Trenton, NJ)
- …for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of ... clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming ... regulatory meetings/workshops/conferences remains current. **Qualifications** + Master's degree in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more