Lykos Therapeutics is hiring a
REMS Senior/Manager in Worldwide

Summary

The job is for a REMS Manager at Lykos Therapeutics, a company committed to developing novel therapies for mental health conditions. The role involves managing the REMS program for MDMA-assisted therapy, coordinating meetings, ensuring compliance, and managing required documents. The company values diversity and inclusion and offers a competitive benefit package.

Requirements

• Bachelor's degree (or equivalent) in relevant field
• A minimum of 4-6 years of experience in the pharmaceutical industry, with 2-3 years of experience in REMS development and administration
• Knowledge of healthcare regulations
• Ability to critically assess website content and user-interfaces with an emphasis on usability and target audience
• Excellent oral and written communication skills
• Fluent in English (oral and writing)
• Strong proficiency in Microsoft Office suite, Veeva Quality Docs and Veeva QMS Vaults
• Ability to work effectively and collaboratively in a virtual work environment

Responsibilities

• Manage REMS contractor vendors, work orders, and budgets
• Coordinate and manage all REMS meetings with internal stakeholders and REMS vendor
• Support presentation development, reporting on key data, analytics, and processes to senior leadership
• Develop and manage REMS Non-Compliance Review Committee (NCRC), including governing documents, non-compliance issue reviews, and documentation and communication of Committee meetings and decisions
• Manage and route all required REMS documents, materials(post-approval) and associated change control requests to internal stakeholders, as required
• Support daily REMS. functions as required to meet business and regulatory requirements, including audit plan compliance and REMS assessment reports to FDA

Benefits

• Paid Time Off (PTO)
• Sick Time
• Holiday Pay
• Medical, dental, vision, and life insurance
• Employer funded mental health HRA
• 401k
• FSA
• Pet Insurance
• Home Office Stipend