Senior Corporate Compliance Manager – Monitoring

United Therapeutics Corporation•RTP, NC, NC

3d•Remote

About The Position

The Senior Corporate Compliance Manager will have primary responsibility for Back-End Monitoring (BEM) and related oversight activities at both the strategic and tactical level. This role will manage, coordinate, and conduct live monitoring, support internal investigations and audits, and provide support in managing associated tasks for UT's Risk Assessment and Mitigation Process (RAMP).

Requirements

Bachelor’s Degree in health science or related field
10+ years of compliance experience in the life sciences industry (pharmaceutical, medical or biotechnology) with a Bachelor's Degree or 8+ years of compliance experience in the life sciences industry (pharmaceutical, medical or biotechnology) with a Master's Degree
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, privacy laws, industry codes
Excellent analytical and problem-solving skills with the ability to organize and interpret complex data and identify trends to facilitate understanding of key information and provide actionable insights and recommendations
Understanding of simple statistical sampling methods to facilitate risk-based sampling
Skilled at effectively communicating findings, trends/patterns, and recommendations both verbally and in writing to leadership and stakeholders through comprehensive reports
Demonstrated expertise in compliance monitoring, auditing, and issue remediation
Demonstrated knowledge of regulatory and compliance requirements including Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, Sunshine Act, and other relevant regulations
Proficiency with Microsoft Office Suite of products; intermediate to advanced level skills in Word, Outlook.
Advanced skills in Excel and Power BI (e.g., V-Lookups, Pivot Tables, data queries, visualization, data import and format conversions), PowerPoint (e.g. development of slide decks including text and graphics), and Smartsheet (e.g. case tracking)
Ability to build professional relationships with internal customers and partners
Acts with a sense of urgency; high motivation and ability to take initiative, follow through, and complete projects in a professional and expeditious manner
Proficiency with and/or ability to learn varied industry software products, such as Veeva, Smart Sheets, Sharepoint, Centris, and similar systems supporting day-to-day compliance operations

Nice To Haves

Master’s Degree in health science or related field
6+ years of experience with aggregating and analyzing structured and unstructured data including reporting and visualizing key risk/performance indicators
Certified Compliance & Ethics Professional (CCEP) CCEP, or equivalent
Certified Fraud Examiner (CFE)-ACFE CFE, or equivalent
Certified Internal Auditor (CIA) CIA, or equivalent
Data management & analytics background
Prior experience in field roles (e.g., commercial, medical)

Responsibilities

Lead and oversee the strategy, development and execution of ongoing Back-End Monitoring (BEM) activities, including document collection, review, oversight, tracking, and follow-up corrective actions. Areas will include activities such as HCP engagements, patient interactions, meals and other transfers of value, and Concur expense data.
Ensure achievement of strategic goals.
Manage, coordinate, and conduct live monitoring activities, ensuring issues are documented, escalated, and resolved appropriately
Maintain all related Compliance trackers (e.g., Issue Tracker, Management Action Plans, monitoring logs, and other oversight tools) to ensure completeness, accuracy, and timely follow-up
Perform root cause analysis of noted compliance issues, trending of identified and emerging risks, and tracking of remediation
Facilitate data collection efforts and analyses related to ad hoc requests from senior members of the Compliance team
Oversee and review the work of contractors and temporary associates, as needed
Provide investigation support, including information gathering, documentation, and coordination with internal stakeholders
Manage the coordination of compliance audits, under the direction of Risk Management, including planning, execution, interviews, and documentation of findings and outcomes
Support UT’s Risk Assessment and Mitigation Process (RAMP), including documentation of remediation outcomes, conducting trend analyses, and preparing executive-level reports
Contribute to the development and tracking of management action plans and remediation activities
Maintain UT’s Compliance incident management and reporting system, ensuring timely documentation, follow-up, and resolution
Recognize and respond promptly to compliance issues, escalating and addressing concerns to improve processes and communications
Collaborate across Compliance functions to ensure alignment and consistency in monitoring, remediation, and reporting
Recommend and implement new and updates to existing functional practices, policies and systems
Perform other departmental duties as assigned