Job Description

(Senior) Manager, REMS

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.
• 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.

For NYCCompensation Description (annually): 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 pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.

Base salary per annum: $130,000 - $180,000 USD.

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.

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