Senior Corporate Compliance Manager – Monitoring, Auditing & Investigations

United Therapeutics Corporation • NC

89d

About The Position

United Therapeutics is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies to expand the availability of transplantable organs. Founded in 1996, the company has six FDA-approved therapies and is working on additional treatments for pulmonary arterial hypertension (PAH) and pulmonary fibrosis (PF). The role involves overseeing back-end monitoring (BEM) and risk assessment and mitigation (RAMP) activities, ensuring compliance with FDA regulations and industry codes, and contributing to the effectiveness of the compliance program.

Requirements

• Bachelor’s Degree in health science or related field with 10+ years of compliance experience in the life sciences industry, or Master's degree with 8+ years of compliance experience.
• 6+ years of experience in corporate compliance monitoring, auditing, and investigations roles.
• Full knowledge of healthcare laws and regulations under the FDA, fraud and abuse laws, and industry codes.
• Excellent analytical and problem-solving skills.
• Understanding of simple statistical sampling methods.
• Skilled at effectively communicating findings and recommendations.
• Demonstrated expertise in compliance monitoring, auditing, and issue remediation.
• Proficiency with Microsoft Office Suite, especially advanced skills in Excel and PowerPoint.
• Ability to build professional relationships with internal customers and partners.
• Ability to travel up to 30%.

Nice To Haves

• Master’s Degree in health science or related field.
• 6+ years of experience with aggregating and analyzing structured and unstructured data.
• Certified Compliance Professional (CCEP) or equivalent.
• Data management & analytics and finance/accounting background.

Responsibilities

• 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 to ensure completeness, accuracy, and timely follow-up.
• Perform root cause analysis of noted compliance issues and track remediation.
• Facilitate data collection efforts and analyses related to ad hoc requests from senior members of the Compliance team.
• Provide investigation support, including information gathering and documentation.
• Manage the coordination of compliance audits.
• Support UT’s Risk Assessment and Mitigation Process (RAMP).
• Maintain UT’s Compliance incident management and reporting system.
• Collaborate across Compliance functions to ensure alignment and consistency.

Benefits

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off & paid parental leave benefits.
• Disability benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees