Paralegal and Legal & Compliance Operations Manager
- Compensation
- $120K–$155K / yr
- Location
- Somerville, MA
- Work setup
- Hybrid
- Seniority
- Not specified
- Employment
- Contract
- Experience
- Not specified
- Category
- Legal
- Posted
Skills
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, including hub services, copay assistance, free goods, and independent patient assistance foundations, and the compliance considerations attached to
- Experience supporting outcomes-based agreements and the government price reporting considerations associated with them.
- Experience supporting international commercial partnerships and the associated 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.
Full description
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
Position Description:
The Paralegal and Legal & Compliance Operations Manager pairs substantive paralegal work with ownership of the operational engine behind the Legal and Compliance function. This position will manage the contract lifecycle, corporate governance records, and entity administration; execute the recurring obligations of the healthcare compliance program, including federal and state transparency reporting, engagement documentation, exclusion screening, policy administration, and training; and own the systems, calendars, metrics, and vendor relationships that allow a lean department to operate at commercial scale.
This position is well suited to an experienced in-house paralegal who is seeking a broader remit than a traditional paralegal seat, or to a compliance operations professional who brings strong transactional and governance experience. The role is an individual contributor position with significant autonomy and cross-functional visibility.
Job Duties and Responsibilities:
Contract Lifecycle and Transactional Support (approximately 30 percent)
- Serve as day-to-day administrator of the contract lifecycle management system, including intake triage, routing, template selection, version control, execution through the electronic signature platform, and post-execution filing and obligation tracking.
- Prepare first drafts of routine agreements from approved templates, including confidentiality agreements, consulting and advisory board agreements, master services agreements, statements of work, speaker agreements, data use agreements, and business associate agreements.
- Coordinate review across Legal, Compliance, Finance, Procurement, Quality, and Privacy, and escalate non-standard terms and playbook deviations to the responsible attorney.
- Maintain the contract repository, the signature authority matrix, and the renewal and expiration calendar, and give business owners advance notice of upcoming decision points.
- Support qualified treatment center agreements, payer and outcomes-based agreements, clinical trial and site agreements, and vendor onboarding documentation at the direction of the responsible attorneys.