Remote Senior REMS & Specialty Pharmacy Operations Leader

Compass Pathways Inc.; Jersey City (NJ); Remote; USD 160,000 - 190,000; Full time

Benefits offered by this job

flexibility & generous time off

parental & reproductive support

health & medical

mental health & wellbeing

financial health

Job summary

Compass Pathways plc, a leading biotechnology company focused on advancing new treatments in mental health, seeks a Senior Manager, REMS & Specialty Pharmacy Operations to implement and optimize REMS programs and distribution for COMP360 in the United States.

This remote-East Coast role will oversee REMS and specialty pharmacy workflow, train partners, and monitor performance in a highly regulated environment.

Qualifications

• 5–8 years in pharmaceutical, biotechnology, specialty pharmacy, healthcare services or a related field
• Experience supporting REMS programs, specialty pharmacy operations, patient services, access operations, or trade and distribution in regulated settings
• Experience managing operational projects and coordinating cross-functional stakeholders
• Experience working with external vendors and healthcare partners

Responsibilities

• Support implementation and ongoing execution of REMS workflows, including site certification, training, patient enrollment, documentation, monitoring and reporting
• Coordinate activities to ensure REMS compliance and consistent execution across sites and partners
• Maintain REMS SOPs, training materials, job aids, and workflows
• Monitor REMS performance metrics, deviations, and noncompliance indicators; coordinate intake, triage, and escalation
• Support audit readiness, documentation management and interactive response preparation
• Support specialty pharmacy operational workflows and distribution processes
• Coordinate onboarding, training, and readiness for specialty pharmacy partners
• Monitor performance metrics, service levels, turnaround times, and compliance indicators
• Identify and resolve operational issues with stakeholders
• Support distribution-related process improvements and initiatives
• Serve as primary operational contact for REMS Administrator and partners
• Track vendor deliverables, metrics, risks, and dependencies
• Support governance meetings and issue resolution with vendors
• Coordinate escalation of compliance concerns to leadership
• Partner with Quality on vendor qualification and SOPs
• Collaborate with Regulatory, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams
• Translate REMS requirements into executable workflows
• Coordinate cross-functional activities for launch readiness and ongoing operations
• Provide updates on performance, risks and mitigation
• Support change management due to regulatory updates or vendor changes
• Support launch readiness planning and execution, testing, training, and readiness assessments
• Analyze data and feedback to identify trends and improvements
• Develop routine operational reports and dashboards
• Facilitate cross-functional reviews of trends and improvements
• Contribute to scalable compliant processes

Skills

FDA REMS programs

Specialty pharmacy ops

Project management

Analytical skills

Operational reporting

Cross-functional collaboration

Communication

MS Office

Education

MBA, MPH, PharmD, MS or equivalent

Tools

MS Office Suite

Job description

Compass Pathways plc, a leading biotechnology company focused on advancing new treatments in mental health, seeks a Senior Manager, REMS & Specialty Pharmacy Operations to implement and optimize REMS programs and distribution for COMP360 in the United States.

This remote-East Coast role will oversee REMS and specialty pharmacy workflow, train partners, and monitor performance in a highly regulated environment.