Senior Manager, REMS Advisor Lead

REMS Advisor Team Leadership & Development

• Partner with the Director, REMS Advisors to develop and execute operational strategies for daily team management, scalability planning, and geographic expansion
• Assess current team structure and forecast future operational needs to ensure the REMS Advisor Team can scale effectively based on program demands and geographic distribution
• Lead the full employee lifecycle for REMS Advisors, including recruitment, hiring, onboarding, performance management, coaching, and development planning
• Collaborate with the Director, REMS Advisors and Learning & Development Team to design and implement comprehensive, ongoing training curricula for REMS Advisors
• Direct all training activities in partnership with the REMS Training Team, ensuring REMS Advisors demonstrate required competencies before performing their roles independently
• Ensure REMS Advisor staff maintains compliance with all REMS program training and mandatory corporate training requirements
• Coach and mentor REMS Advisors to achieve performance excellence; establish Individual Development Plans (IDPs) that align short- and long-term career aspirations with business needs
• Guide goal-setting processes using SMART criteria to establish clear, measurable departmental and individual objectives
• Continuously monitor staffing levels and workload capacity; develop business justification documentation to request additional resources when needed
• Manage shared mailbox oversight and ensure equitable workload distribution across the team

Program Performance, Analytics & Continuous Improvement

• Oversee creation and analysis of KPI reports within the REMS application to drive timely, data-informed prescriber outreach and prevent undue administrative burden
• Monitor key REMS performance metrics and identify opportunities for operational improvement and stakeholder engagement enhancement
• Analyze REMS stakeholder operations and interactions to identify process improvements that reduce administrative burden, increase efficiency, and enhance user experience
• Conduct field observations of REMS Advisors during prescriber outreach and presentations; deliver constructive, actionable feedback to ensure clear and effective REMS education delivery
• Synthesize data trends and translate insights into actionable recommendations to improve business procedures, practices, and stakeholder experiences
• Provide feedback on technology enhancements to improve analytic tracking, reporting capabilities, and operational workflows; communicate recommendations to leadership
• Design and facilitate workshops to share best practices, implementation insights, and lessons learned with REMS Advisors and healthcare professionals
• Partner with cross-functional field teams (Sales, MSLs, Access) to promote REMS best practices and operational excellence initiatives that improve stakeholder efficiency
• Lead monthly REMS review meetings with leadership to present program insights, customer feedback, trends, and improvement opportunities

Regulatory Compliance & Knowledge Management

• Maintain comprehensive knowledge of Center of Excellence operations, including all Standard Operating Procedures (SOPs), work practices, and system functionalities
• Develop, maintain, and implement REMS policies, procedures, and work practices in alignment with regulatory requirements and business needs
• Stay current on FDA REMS regulations and industry trends; ensure internal teams and external stakeholders maintain compliance with regulatory requirements
• Support internal audits and health authority inspections by providing documentation, insights, and subject matter expertise as required
• Collaborate with Legal and Regulatory Strategy teams to ensure all communications and materials undergo appropriate RCR (Regulatory Content Review) process prior to distribution

Technology, Data Management & Cross-Functional Collaboration

• Ensure accurate, current data is maintained in applicable systems used by REMS Advisors
• Oversee and participate in User Acceptance Testing (UAT) for REMS technologies; report findings and recommendations to REMS IT personnel and leadership
• Collaborate with department leadership to assess operational needs, establish project timelines, monitor implementation progress, and evaluate outcomes
• Manage financial planning activities and ensure adherence to approved departmental budget
• Deliver scheduled and ad-hoc reports to leadership as required to support strategic decision-making
• Perform other duties as assigned to support departmental and organizational objectives