- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** ... a key member of the Global Quality Management team, the Audit Manager will collaborate with cross-functional stakeholders to identify risks, drive continuous… more
- Datavant (San Juan, PR)
- …data to power better evidence and improve patient outcomes. As a **CRO Channel Manager ** , you will play a pivotal role in expanding Datavant's impact across the ... our partnerships with Clinical Research Organizations (CROs). The **CRO Channel Manager ** will be responsible for driving commercial outcomes through Datavant's… more
- ThermoFisher Scientific (Wilmington, NC)
- …communities depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is highly preferred **Position Summary** The ... Regulatory Intelligence Manager will play a pivotal role in monitoring, analyzing,...+ **Stakeholder Alignment:** Interact with Regulatory Affairs, Clinical, Quality, Pharmacovigilance and Legal teams to ensure alignment and awareness… more
- Regeneron Pharmaceuticals (Warren, NJ)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing ... relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …your best self. Become a **maker of possible** with us. **Medical Affairs Manager , Infusion Preparation & Delivery (IPD)** **Scope:** In this role under the Director ... marketing for key products. + Continuously develop knowledge of regulatory, pharmacovigilance , and quality assurance requirements in alignment with BD Practice… more
- System One (East Windsor, NJ)
- …Sterile Injectable Products Responsibilities: + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will be responsible ... establishing the internal QA review system to supervise the Pharmacovigilance Group (PVG) function, which is handled by a...the FDA of illegitimate products. + Assist the Associate Manager of QA Compliance in notifying the FDA of… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …(GPS) Operations. This role is pivotal in shaping the delivery of pharmacovigilance (PV) governance to ensure operational requirements are met within a growing ... you can/have:** + This enablement role is accountable for demonstrating pharmacovigilance (PV) technical expertise and leadership, working collaboratively with key… more
- Sanofi Group (Morristown, NJ)
- …for the clinical studies on activities pertaining to the Study Medical Manager (SMM) responsibilities eg: leading or contributing to key study documents and ... opportunities in the therapeutic area. + Under the guidance of his/her manager in the Therapeutic Area department, he/she collaborates with the Coding specialist,… more
- Sanofi Group (Morristown, NJ)
- …Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance , Therapeutic Area Research & Development Groups. + External contacts: ... clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM principal duties and responsibilities… more
- Bristol Myers Squibb (Madison, NJ)
- …management. + Strong knowledge of processes and global regulations for pharmacovigilance and benefit-risk management. + Demonstrated success in navigating a highly ... + US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to...160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays… more