Job overview:
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.
Location: Hybrid in our Jersey City office or remote in the East Coast, United States.
Reports to:Senior Director, REMS & Specialty Pharmacy Operations.
Roles and Responsibilities(include but not limited to):
REMS Operations- 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
Specialty Pharmacy Operations- 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
Vendor Management- 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
Cross-Functional Collaboration- 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
Launch Readiness and Continuous Improvement- 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
Candidate Profile:Experience- 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
Preferred Qualifications- 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
Knowledge & Skills- 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
Compensation Description (annually):Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering.
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
[Base salary per annum]:
$160,000-$190,000 USD
Benefits:For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits".
These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health.
