Manager, REMS Operations

Role: Support the operational management of FDA-mandated REMS programs within a biopharma setting, ensuring compliance and strategic execution. Responsibilities: oversee daily REMS activities, coordinate governance meetings, monitor program health, develop and review REMS materials, and collaborate with cross-functional teams and vendors to meet regulatory requirements. Requirements: 4-6 years of pharmaceutical industry experience, with 2+ years in project or program management; proficiency in Microsoft Office; excellent communication and organizational skills; Bachelor's degree in a relevant field. Preferred: REMS-specific experience. High-Value: pharmaceutical project management, FDA REMS compliance, cross-functional stakeholder engagement, regulatory documentation, risk mitigation. WorkSetup: remote work environment.