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 for pharmaceutical safety
Domain
Pharmaceuticals / Regulatory Compliance (FDA REMS)
Required skills
Team leadership and development, FDA REMS regulatory expertise, operational strategy, performance management, data analytics, cross-functional collaboration, budget management, process improvement, stakeholder engagement, public speaking
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and execute operational strategies for team management and scalability; Lead the full employee lifecycle including recruitment, onboarding, and performance management; Oversee creation and analysis of KPI reports to drive prescriber outreach; Conduct field observations of REMS Advisors to ensure effective education delivery; Maintain comprehensive knowledge of Center of Excellence operations and regulatory SOPs; Collaborate with Legal and Regulatory Strategy teams for content review; Manage financial planning and departmental budget; Design and facilitate workshops to share best practices with the team.
Seniority
Senior, hands-on IC
