Paralegal and Legal & Compliance Operations Manager

The role

This individual will manage the contract lifecycle, corporate governance, and healthcare compliance operations. They will also handle legal operations, department management, and entity administration.

What you will do

• Administer the contract lifecycle management system and electronic signature platform
• Prepare first drafts of routine agreements from approved templates
• Coordinate review across Legal, Compliance, Finance, Procurement, Quality, and Privacy
• Maintain the contract repository, signature authority matrix, and renewal calendar
• Own the operational calendar for federal Open Payments reporting
• Administer state transparency and pharmaceutical marketing obligations
• Manage aggregate spend data flows and reconcile transfers of value
• Process and document engagements with healthcare professionals and organizations
• Maintain the compliance policy library and coordinate annual compliance training
• Maintain corporate minute books, board materials, and entity housekeeping

Required qualifications

• Bachelor's degree, or an American Bar Association approved paralegal certificate combined with equivalent experience
• A minimum of seven years of paralegal, legal operations, or compliance operations experience
• At least three years supporting an in-house legal or compliance function
• Demonstrated experience in the pharmaceutical, biotechnology, or medical device industry
• Working knowledge of the federal Anti-Kickback Statute, the False Claims Act, the Physician Payments Sunshine Act, the PhRMA Code, and Office of Inspector General compliance program guidance
• Hands-on experience administering a contract lifecycle management system and an electronic signature platform
• Demonstrated ownership of a recurring regulatory reporting obligation from data collection through submission

Nice to have

• Experience at a commercial-stage cell or gene therapy company, or in another rare disease or specialty therapeutic setting
• Experience serving as the responsible preparer for Open Payments submission and dispute resolution
• Familiarity with patient support program structures
• Experience supporting outcomes-based agreements and government price reporting considerations
• Experience supporting international commercial partnerships and anti-corruption due diligence
• Professional certification such as Certified Compliance and Ethics Professional, Certified in Healthcare Compliance, NALA Certified Paralegal, or NFPA Registered Paralegal
• Experience at a private equity backed company, or at a company that has recently transitioned from public to private ownership

Benefits

• comprehensive health, life and disability insurance
• employer-matched 401(k) plan
• lifestyle spending account
• flexible time-off + paid holidays and winter holiday period
• tuition reimbursement & loan repayment assistance
• paid parental leave
• paid onsite parking
• commuter subsidy

About the company

Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. They are doers, thinkers and collaborators who embrace and live by their values.