Supports implementation, optimization, and daily execution of U.S. REMS and specialty pharmacy operations for COMP360.
Partners with senior leadership to turn regulatory requirements into scalable patient-centered workflows.
Responsibilities:
Oversees vendor management, compliance metrics, audits, and launch readiness.
Collaborates cross-functionally to resolve issues and drive continuous improvement.
Qualifications:
Requires 5-8 years in pharma/biotech/specialty pharmacy and 2+ years in REMS or regulated operations.
Strong project management, analytical, and communication skills with FDA REMS knowledge.
Compass Pathways plc
Compass Pathways is a biotech developing COMP360 psilocybin for treatment-resistant depression and PTSD, with FDA Breakthrough Therapy designation. Headquartered in London with a U.S. office in New Jersey, it focuses on patient-centered mental health innovation.
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Senior Manager, REMS and Specialty Pharmacy Operations (Fully Remote) • workfromhome, United States