Senior Manager, REMS Operations

Role: Senior Manager, REMS Operations, responsible for overseeing the operational management and execution of FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) programs in the U.S. The role ensures compliance, drives governance, mitigates operational risks, and collaborates with internal teams and external vendors to support REMS objectives. Responsibilities include managing day-to-day operations, coordinating governance meetings, monitoring program health, and maintaining documentation for audits and inspections. Requirements: 4-6 years of pharmaceutical industry experience, with 2+ years in project or program management; proficiency in Microsoft Office; strong communication and organizational skills; bachelor's degree in a relevant field. Preferred experience includes REMS and vendor management. HighValue: focus on REMS programs, regulatory compliance, vendor oversight, cross-functional stakeholder engagement, and remote work capability. The role is based in the U.S. with an emphasis on operational excellence within biopharma regulatory frameworks.