Director REMS Operations

Role: Director of REMS Operations responsible for developing and managing Risk Management Programs, including REMS with Elements to Assure Safe Use, ensuring regulatory compliance and stakeholder engagement. Responsibilities: oversee program development, vendor management, contract development, and collaboration with Regulatory, Medical Affairs, Pharmacovigilance, Legal, and Quality teams; serve as industry representative and internal expert on REMS; monitor program progress, risks, and costs; seek continuous improvement. Requirements: bachelor’s degree, 10+ years in regulated industries, at least 5 years working with FDA regulatory submissions; strong knowledge of FDA regulations on REMS; experience in pharmaceutical safety/regulatory domains, vendor oversight, and software systems. Preferred: master’s degree or MBA, prior experience with call center technologies. High-Value: focus on pharmaceutical safety and regulatory compliance within a regulated environment; leadership role managing a team; hybrid work setup in Parsippany, NJ, with potential industry collaboration. The role emphasizes cross-functional stakeholder coordination, vendor management, and regulatory expertise in pharmaceutical risk mitigation programs.