TL;DR
(Senior) Manager, REMS (Biotech): Managing the Risk Evaluation and Mitigation Strategies (REMS) program for COMP360 with an accent on compliance, operational oversight, and safety data reconciliation. Focus on ensuring adherence to FDA regulations, coordinating cross-functional team activities, and managing vendor-related safety deliverables.
Location: Must be based in the East Coast, US (preference for NYC) or the UK.
Salary: $130,000 – $180,000 USD
Company
A biotechnology company pioneering evidence-based mental health treatments and synthetic psilocybin therapy.
What you will do
- Oversee the delivery of REMS activities according to established quality standards and procedures.
- Conduct reconciliation of REMS data sources, including compliance, shipment, and KPI metrics.
- Serve as the primary point of contact for the REMS mailbox and triage queries for resolution.
- Manage specific REMS issues and escalations within the program.
- Coordinate team meetings and track action items according to the project plan.
- Support the execution of REMS deliverables and reconcile vendor contracts, POs, and invoices.
Requirements
- Must have employment rights in the UK or the US.
- Bachelor’s degree in medical or biological science or equivalent experience.
- Relevant experience in the pharmaceutical industry within pharmacovigilance or quality assurance.
- Proven project management skills including deliverable tracking.
- Prior experience with REMS programs and GxP compliance requirements.
- Detail-oriented approach with proficiency in tracking metrics and safety data.
Nice to have
- Project Management Certification.
- Experience with audits or regulatory inspections.
- Experience working with third-party vendors.
Culture & Benefits
- Competitive base salary with eligibility for discretionary bonuses and equity.
- Commitment to an inclusive workplace with equal opportunity employment.
- Support for professional development in a pioneering medical field.
- Focus on employee wellbeing and reasonable accommodations.