Senior Corporate Compliance Manager – Monitoring

California, US residents click here.

The job details are as follows:

Who We Are

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.
Who You Are

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).

• Monitoring and Oversight:
• 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
• Investigations & Audits:
• 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
• Risk Assessment & Mitigation (RAMP):
• 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
• Compliance Program Support:
• 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

Minimum 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

Preferred Qualifications

• 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)

This is a home-based position for any location in the Continental US and will require 35% travel nationally.

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.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.