Manager, REMS

Are you ready to turn regulatory rigor into real patient impact by safeguarding access to transformative medicines? As Manager REMS, you will lead the operational execution of complex Risk Evaluation and Mitigation Strategy programs that protect patients and enable the responsible use of our therapies. Your work will ensure compliant, effective delivery across the REMS lifecycle—keeping programs inspection-ready, data-driven, and aligned with FDA expectations. You will partner closely with REMS leadership, cross-functional teams, and specialized vendors to maintain end-to-end oversight, elevate performance, and resolve risks before they become issues. This role sits at the intersection of safety, commercial execution, and regulatory excellence—where disciplined operations translate into uninterrupted patient access and business continuity. Can you turn complex data into clear decisions that keep mission-critical programs on track? Every improvement you drive—whether in data reconciliation, vendor performance, or submission quality—helps sustain reliable access to medicines for people who need them most, including those living with cancer. If you are energized by high standards, crisp execution, and measurable outcomes, this role offers the scope and responsibility to make your impact felt quickly. **Accountabilities** - FDA REMS submissions: Prepare, coordinate, and deliver high-quality REMS filings and updates on time, ensuring accuracy, completeness, and alignment with company procedures and FDA guidance. - FDA communications: Coordinate, submit, and track all communications to FDA, including information requests, formal correspondence, and submissions for REMS revisions and modifications; maintain complete submission archives. - REMS oversight and governance: Lead ongoing governance of vendor performance, including monthly monitoring of service level agreements, key performance indicators, and critical program metrics; drive remediation when performance deviates. - Compliance management and CAPA leadership: Identify, escalate, and resolve quality issues; document and track corrective and preventive actions, verifying effectiveness and preventing recurrence. - Data oversight and reconciliation: Conduct routine reconciliation across compliance, shipment, and KPI data sources to maintain robust oversight and demonstrate program compliance. - SLA and KPI monitoring and reporting: In partnership with compliance and inspection readiness experts, analyze and report agreed metrics with clear commentary and follow-through on remediation actions. - Inquiry and issue triage: Manage the REMS shared mailbox; respond to inquiries and route questions to the right team members for timely, accurate resolution. - Team operations and program control: Coordinate team meetings, maintain agendas and minutes, and track decisions, risks, and actions against the project plan to sustain program cadence and transparency. - Financial administration: Manage and reconcile invoices against contracts and purchase orders; support timely accruals and budget tracking to ensure fiscal discipline. - Process and tool improvement: Develop, enhance, and maintain reporting tools, processes, and technology solutions that increase efficiency, accuracy, and scalability, including practical integration of AI where it improves outcomes. - Audit and inspection support: Prepare evidence packages and readiness materials; participate in internal/external audits and regulatory inspections, ensuring clear, complete, and defensible documentation. - Continuous improvement and innovation: Standardize and optimize REMS practices, promoting methods that reduce risk, streamline execution, and strengthen inspection readiness across the portfolio. **Essential Skills/Experience** - Bachelor’s degree in a life science, health-related, or business discipline; advanced degree preferred. - 5+ years of experience in REMS operations, pharmacovigilance/patient safety, regulatory operations…