Senior Manager, REMS and Specialty Pharmacy Operations (Fully Remote)

Compass Pathways plc; United States; Remote; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

Compass Pathways plc is seeking a REMS/regulated operations professional to support the implementation, optimization, and daily execution of U.S. REMS and specialty pharmacy operations for COMP360.

The role involves partnering with senior leadership to translate regulatory requirements into scalable, patient-centered workflows, overseeing vendor management and audits, and collaborating cross-functionally to drive continuous improvement.

Qualifikationen

• 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.

Aufgaben

• Oversees vendor management, compliance metrics, audits, and launch readiness.
• Collaborates cross-functionally to resolve issues and drive continuous improvement.

Kenntnisse

Project management

Analytical skills

Communication skills

FDA REMS knowledge

Jobbeschreibung

• 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.