Teams at United Therapeutics

Lead oversight and strategy for SAE and AESI handling across clinical trials, ensuring regulatory compliance, inspection readiness, process improvements, vendor and team management, training, and quality assurance to support global safety surveillance and benefit/risk assessment for developmental products.

Support the CEO and Board by coordinating board and Scientific Advisory Board activities, preparing and distributing confidential governance materials, managing executive schedules and complex travel logistics, partnering with legal and security, maintaining records, and assisting on special projects and strategic initiatives.

Ensure cGMP/QSR compliance for ExVivo Organ Perfusion services and medical device manufacturing. Review and maintain quality documentation, support material release, manage document lifecycle, perform deviation and complaint investigations, assist validation efforts, support regulatory inspections, maintain quality records, and provide occasional 24/7 remote case/data review during on-call rotations.