Senior Manager, REMS and Specialty Pharmacy Operations

Compass Pathways•Jersey City, NJ

1d•Hybrid

About The Position

The Senior Manager, REMS & Specialty Pharmacy Operations will support the implementation, execution, and ongoing optimization of the REMS program and specialty pharmacy operational model for COMP360 in the United States. Partnering closely with the Senior Director, this role will help translate approved regulatory requirements and business objectives into compliant, scalable, and patient-centered operational processes. This individual will oversee day-to-day REMS and specialty pharmacy operations, support vendor management and operational readiness activities, monitor program performance, and collaborate cross-functionally to ensure successful execution of approved REMS and distribution strategies. The ideal candidate brings experience in REMS, specialty pharmacy, patient services, or related pharmaceutical operations and thrives in a highly regulated environment.

Requirements

5-8 years of experience in pharmaceutical, biotechnology, specialty pharmacy, healthcare services, patient support services, market access, or a related healthcare industry
At least 2 years of experience supporting REMS programs, specialty pharmacy operations, patient services, access operations, trade and distribution operations, or other regulated healthcare programs
Experience managing operational projects and coordinating cross-functional stakeholders
Experience working with external vendors, service providers, specialty pharmacies, or healthcare partners
Working knowledge of FDA REMS programs and associated operational requirements
Understanding of specialty pharmacy, patient access, and limited distribution workflows
Strong project management, organizational, and prioritization skills, with the ability to manage multiple priorities and dependencies in a fast-paced environment
Strong analytical, problem-solving, and issue-resolution skills
Experience tracking metrics and developing operational reports
Excellent written and verbal communication skills
Proficiency with Microsoft Office applications and operational reporting tools

Nice To Haves

Advanced degree such as an MBA, MPH, PharmD, MS, or equivalent preferred
Experience supporting product launch, launch readiness, or commercialization activities
Experience developing or maintaining SOPs, training materials, operational workflows, and process documentation
Knowledge of pharmaceutical compliance requirements and healthcare operational processes

Responsibilities

Support implementation and ongoing execution of REMS operational workflows, including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting
Coordinate operational activities required to support REMS compliance and consistent execution across certified treatment sites and operational partners
Maintain REMS process documentation, standard operating procedures, training materials, job aids, and operational workflows
Monitor REMS performance metrics, reports, deviations, exceptions, and potential noncompliance indicators; coordinate intake, documentation, triage, and escalation in accordance with approved procedures
Support audit and inspection readiness activities, including documentation management, operational simulations, and response preparation
Support implementation and ongoing management of specialty pharmacy operational workflows and distribution processes
Coordinate onboarding, training, and operational readiness activities for specialty pharmacy partners
Monitor specialty pharmacy performance metrics, service levels, turnaround times, and operational compliance indicators
Partner with specialty pharmacy stakeholders to identify, troubleshoot, and resolve operational issues affecting treatment sites, healthcare providers, or patients
Support execution of distribution-related process improvements and operational initiatives
Serve as a primary day-to-day operational contact for the REMS Administrator, REMS operational vendors, and specialty pharmacy partners
Track vendor deliverables, action items, performance metrics, service-level commitments, risks, and dependencies
Support recurring business reviews and operational governance meetings with vendor partners
Coordinate follow-up and resolution of vendor-related issues and escalate operational risks, compliance concerns, or unresolved matters to appropriate stakeholders and leadership
Partner with Quality on vendor qualification, quality agreements, and supplier quality oversight activities, as applicable
Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams to support operational execution
Translate approved REMS requirements into executable workflows while maintaining alignment with established functional ownership, governance, and escalation pathways
Coordinate cross-functional activities required to support launch readiness, ongoing program operations, and operational enhancements
Participate in governance forums and provide updates on operational performance, risks, dependencies, and mitigation plans
Support change management activities resulting from regulatory updates, process improvements, vendor changes, or evolving business needs
Support launch readiness planning and execution, including operational testing, training deployment, simulation exercises, process validation, and readiness assessments
Analyze operational data and stakeholder feedback to identify trends, process constraints, and improvement opportunities
Develop routine operational reports and dashboards to support performance monitoring and decision-making
Facilitate cross-functional review of trends, coordinate approved improvements, and track implementation of corrective or preventive actions
Contribute to scalable processes that support compliant operations and an effective treatment site and patient experience