Senior Corporate Compliance Manager – Monitoring

🕒 June 30

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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United Therapeutics Corporation

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

United Therapeutics Corporation is a biotechnology company focused on developing novel pharmaceutical therapies and technologies to treat chronic and life‑threatening conditions and to expand the availability of transplantable organs. Founded to address a rare disease, the company develops treatments for pulmonary arterial hypertension and other orphan and pulmonary diseases, and works on technologies related to organ transplantation and support for end‑stage organ disease. United Therapeutics is also notable for being the first publicly‑traded biotech or pharmaceutical company to adopt the public benefit corporation structure.

📋 Description

• 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. • 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

🎯 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

🏖️ Benefits

• medical / dental / vision / prescription coverage • employee wellness resources • savings plans (401k and ESPP) • paid time off & paid parental leave benefits • disability benefits