Paralegal and Legal & Compliance Operations Manager

Genetix Biotherapeutics•Somerville, MA

4d•Hybrid

About The Position

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.

Requirements

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, including at least three years supporting an in-house legal or compliance function.
Demonstrated experience in the pharmaceutical, biotechnology, or medical device industry, with 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.
Exceptional attention to detail and document discipline, with the ability to manage multiple concurrent deadlines without close supervision.
Sound judgment regarding privilege, confidentiality, and when a matter must be escalated to counsel.

Nice To Haves

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 each.
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.

Responsibilities

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.
Own the operational calendar for federal Open Payments reporting under the Physician Payments Sunshine Act, including data collection, validation, dispute resolution, attestation, and submission.
Administer state transparency and pharmaceutical marketing obligations, including the Massachusetts pharmaceutical and medical device manufacturer code of conduct filing, the California comprehensive compliance program declaration, and Vermont, Connecticut, Nevada, and District of Columbia requirements, together with pharmaceutical representative licensing and registration where applicable.
Manage aggregate spend data flows across Finance, travel and expense, Medical Affairs, and third-party vendors, and reconcile reported transfers of value to source records.
Process and document engagements with healthcare professionals and healthcare organizations, including needs assessments, fair market value determinations, exclusion and debarment screening, conflict-of-interest disclosures, and verification of post-engagement deliverables.
Support the intake and review workflow for grants, charitable contributions, medical education support, and investigator-initiated study requests through the applicable review committees.
Maintain the compliance policy library, including version control, scheduled periodic review, attestation tracking, and archiving of superseded versions.
Coordinate the onboarding and annual compliance training curriculum in the learning management system, and track completion, escalation, and remediation.
Prepare agendas, materials, and minutes for the Compliance Committee, and support periodic reporting to executive leadership and the Board of Directors.
Support monitoring and auditing activities, including field ride-along documentation, speaker program monitoring logistics, expense report review, and corrective action tracking.
Provide intake and administrative support for hotline reports and internal investigations under attorney direction, maintaining strict confidentiality and an accurate investigation log.
Maintain corporate minute books, board and committee materials, written consents, resolutions, and officer and director records for the parent company and each subsidiary.
Manage entity housekeeping, including annual reports, franchise tax filings, foreign qualifications, registered agent relationships, certificates of good standing, and secretary certificates.
Support equity administration and capitalization recordkeeping in coordination with Finance and outside counsel.
Coordinate corporate authorizations, notarizations, apostilles, and signature packets for domestic and international transactions, including partnership and distribution arrangements outside the United States.
Administer the matter management system, outside counsel guidelines, engagement letters, conflict waivers, rate approvals, electronic billing, invoice review, and accrual reporting.
Track department budget and spend against plan, and prepare periodic reporting for the General Counsel.
Administer legal holds and the records retention schedule, coordinate document collection and preservation, and support litigation, subpoena, and government inquiry responses under attorney direction.
Coordinate intellectual property docketing and annuity deadlines with outside patent counsel.
Support privacy operations, including data subject access requests, records of processing activities, and vendor privacy due diligence.
Evaluate, implement, and administer department technology, and build the process documentation, dashboards, and metrics that improve cycle time and visibility.