(Senior) Manager, REMS

Compass Pathways • London, NY

22h

About The Position

The (Senior) Manager, REMS plays a key leadership role in the management of our Risk Evaluation and Mitigation Strategies (REMS) Program for COMP360. The REMS manager will work closely with REMS team members to ensure REMS compliance, operational excellence and quality documentation is in place for the program.

Requirements

• Bachelor’s degree (preferably in medical or biological science) or equivalent by experience
• Relevant clinical/medical experience in the pharmaceutical industry, with experience in pharmacovigilance and/or quality assurance
• Previous demonstration of basic project management skills including tracking deliverables
• Prior REMS experience
• Strong communication skills and fluency in English
• Prior experience tracking metrics and/or compliance and safety data including trending and interpreting data
• Detail oriented and Proficient in Microsoft applications
• Broad knowledge and understanding of FDA regulations and compliance requirements in a GxP environment
• Aligned to our values and mission

Nice To Haves

• Project Management Certification a plus
• Audit or Inspection experience
• Working with third-party vendors advantageous

Responsibilities

• Support delivery of REMS activities to agreed timelines according to company quality standards and REMS procedures.
• Conduct reconciliation of various REMS data sources including compliance data, shipment data, Key performance indicator data to ensure proper oversight and compliance of the REMS program
• Manage the REMS shared mailbox, respond to REMS queries and triage questions/issues as needed for resolution amongst REMS team members
• Manage REMS specific issues and escalations, as applicable
• Coordinate regular team meetings; track outstanding action items and activities per the project plan
• Help manage and reconcile contracts, POs and invoices
• Support REMS processes and procedures with execution of key deliverables

What This Job Offers

• Job Type: Full-time
• Career Level: Manager