Senior Manager, REMS and Specialty Pharmacy Operations
New
C
Compass Pathways plcBiotechnology, pharmaceuticals
Remote in the East Coast, United States.Full-TimeManager
Salary$160,000 — $190,000 USD
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Job Details
- Experience
- 5-8 years of experience; 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
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Have 5-8 years of experience in pharmaceutical, biotechnology, specialty pharmacy, healthcare services, patient support services, market access, or a related healthcare industry.
- Have 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.
- Have experience managing operational projects and coordinating cross-functional stakeholders.
- Have experience working with external vendors, service providers, specialty pharmacies, or healthcare partners.
- Have working knowledge of FDA REMS programs and associated operational requirements.
- Understand specialty pharmacy, patient access, and limited distribution workflows.
- Have experience tracking metrics and developing operational reports.
- Be proficient with Microsoft Office applications and operational reporting tools.
- Have strong project management, organizational, prioritization, analytical, problem-solving, and issue-resolution skills.
- Have excellent written and verbal communication skills.
- An advanced degree such as an MBA, MPH, PharmD, MS, or equivalent is preferred.
- Experience supporting product launch, launch readiness, or commercialization activities is preferred.
- Experience developing or maintaining SOPs, training materials, operational workflows, and process documentation is preferred.
- Knowledge of pharmaceutical compliance requirements and healthcare operational processes is preferred.
Responsibilities
- Support implementation and ongoing execution of REMS operational workflows, including site certification, user training, patient enrollment, treatment documentation, monitoring, and reporting.
- Coordinate activities that support REMS compliance across certified treatment sites and operational partners.
- Maintain REMS process documentation, standard operating procedures, training materials, job aids, and workflows.
- Monitor REMS and specialty pharmacy metrics, service levels, reports, deviations, exceptions, and compliance indicators; coordinate issue intake, documentation, triage, and escalation.
- Support specialty pharmacy onboarding, training, operational readiness, distribution workflows, and process improvements.
- Manage day-to-day operational relationships with the REMS Administrator, REMS vendors, and specialty pharmacy partners; track deliverables, performance, risks, and dependencies.
- Coordinate vendor governance meetings and follow-up, and partner with Quality on vendor qualification, quality agreements, and supplier quality oversight as applicable.
- Partner with Regulatory Affairs, Quality, Pharmacovigilance, Compliance, Medical Affairs, Patient Engagement, Market Access, Trade & Distribution, and Commercial teams on operational execution.
- Support launch readiness through operational testing, training deployment, simulations, process validation, and readiness assessments.
- Develop operational reports and dashboards, analyze performance data and stakeholder feedback, and coordinate approved improvements and corrective or preventive actions.
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