(Senior) Manager, REMS

Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: 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. Location: East Coast, United States (proximity to New York City preferred). Reports to: Sr. Director, Clinical Safety and Pharmacovigilance. Role and Responsibilities: (include but not limited to)

• 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

Candidate Profile:

• 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
• Project Management Certification a plus
• Audit or Inspection experience Working with third-party vendors advantageous
• Aligned to our values and mission

Benefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.