Senior Manager, REMS Advisor Lead
Core
Lead a high-performing team of REMS Advisors to deliver regulatory education to certified prescribers and healthcare professionals, optimizing operational excellence and compliance.
Role type
Senior Manager, REMS Program Operations
Builds
REMS education programs, operational workflows, and team capabilities
Domain
Pharmaceutical / Regulatory Compliance (FDA REMS)
Required skills
Team leadership, operational strategy, performance management, regulatory compliance (FDA REMS), data analytics, stakeholder engagement, budget management, process improvement
Preferred skills
Conflict resolution, public speaking, strategic planning, cross-functional collaboration
Technologies
REMS application systems, web-conferencing tools
Responsibilities
Develop and execute operational strategies for team management and scalability; lead the full employee lifecycle including recruitment and development; oversee creation and analysis of KPI reports to drive prescriber outreach; conduct field observations of Advisors to ensure effective education delivery; maintain compliance with FDA REMS regulations and support internal audits; manage financial planning and departmental budget; partner with cross-functional teams to promote operational excellence.
Seniority
Senior, hands-on IC with management responsibilities
