Senior Corporate Compliance Manager Monitoring, Auditing & Investigations

Compliance Monitoring And Risk Assessment Specialist

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq : UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

You are both strategic and tactical when it comes to back end monitoring (BEM) and risk assessment and mitigation (RAMP). You are a compliance subject matter expert with a working understanding of FDA regulations, fraud and abuse laws, and industry codes. You have exceptional attention to detail when it comes to ensuring monitoring activities, trackers, and corrective actions are completed accurately, consistently, and in alignment with compliance department objectives. You understand the importance of this role and how it will contribute directly to the effectiveness of UT's compliance program by maintaining critical compliance systems, coordinating monitoring activities, and supporting risk management processes. You thrive in an environment that is collaborative and fast paced and are excited to be part of a company that is forward thinking and innovative, like United Therapeutics.

Monitoring and Oversight

• Lead and oversee the strategy, development and execution of ongoing Back-End Monitoring (BEM) activities.
• Manage, coordinate, and conduct live monitoring activities.
• Maintain all related Compliance trackers.
• Perform root cause analysis of noted compliance issues.
• Facilitate data collection efforts and analyses related to ad hoc requests.
• Oversee and review the work of contractors and temporary associates.
• Investigations & Audits
• Provide investigation support.
• Manage the coordination of compliance audits.

Risk Assessment & Mitigation (RAMP)

Minimum Requirements

Preferred Qualifications

This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.