United Therapeutics Corporation

Senior Corporate Compliance Manager - Monitoring

United Therapeutics Corporation$120K — $150K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in health science or related field
  • 10+ years of compliance experience in life sciences industry or 8+ years with a Master's Degree
  • 6+ years in compliance monitoring, auditing, and investigations
  • Comprehensive knowledge of healthcare laws and regulations (FDA, fraud and abuse, privacy laws)
  • Proficient in Microsoft Office Suite, especially Excel and Power BI, for data analysis and visualization
  • Strong analytical and problem-solving skills with data interpretation capabilities
  • Effective communication skills for reporting trends and findings to stakeholders

Responsibilities

  • Lead the execution of Back-End Monitoring (BEM) activities including oversight and tracking
  • Manage live monitoring processes to document and resolve compliance issues
  • Maintain comprehensive compliance trackers for timely follow-up and accurate reporting
  • Conduct root cause analyses on compliance issues and track remediation efforts
  • Support internal investigations and audits, coordinating with stakeholders
  • Facilitate data collection and analysis for compliance assessments
  • Collaborate with compliance functions to ensure process alignment

Benefits

  • Medical, dental, and vision coverage
  • Employee wellness resources
  • 401k savings plan and Employee Stock Purchase Plan (ESPP)
  • Paid time off and paid parental leave benefits
  • Disability benefits and other wellness programs
Full Job Description
California, US residents click here.

The job details are as follows:

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.

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

About United Therapeutics Corporation

United Therapeutics Corporation is a biotechnology company that develops and commercializes innovative products to address the unmet medical needs of patients with chronic and life-threatening diseases. The company was founded in 1996 and is headquartered in Silver Spring, Maryland. United Therapeutics has a portfolio of products that includes treatments for pulmonary arterial hypertension, neuroblastoma, and other diseases. The company's mission is to improve the lives of patients by developing and commercializing innovative therapies. United Therapeutics has received numerous awards for its contributions to the biotechnology industry.
Learn more about United Therapeutics Corporation
Size
965 employees
Market Cap
$12.4 billion
Industry
Net Income
$514.8 million
5 Year Trend
+1.1%
Revenue
$1.4 billion
NASDAQ

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