Senior Director, US Risk Management & Product Safety (REMS)

Role: Senior Director, US Risk Management & Product Safety, leading US safety strategies for complex medicines, ensuring FDA compliance and risk mitigation. Responsibilities include developing and overseeing REMS programs, managing vendor performance, and leading safety-related labeling and reporting. The role also involves regulatory compliance, inspection readiness, and engaging with health authorities. Qualifications: Bachelor's in Healthcare/Life Sciences required; advanced degree (PharmD, PhD, MD) preferred; 10+ years PV leadership with at least 8 years industry experience; deep knowledge of FDA REMS requirements, pharmacovigilance, and risk management. Skills include strategic leadership, communication, influencing, decision-making, and familiarity with safety databases and analytics tools. High-value specifics: focus on US REMS strategy, FDA interactions, risk management for high-profile medicines, and overseeing safety operations. The position is based in East Hanover, NJ, with a requirement for onsite presence and no relocation support.