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Senior Corporate Compliance Manager – Monitoring

United Therapeutics -
Remote

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Job Details

Full-time

Benefits

Paid parental leave
Employee stock purchase plan
Disability insurance
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Prescription drug insurance

Qualifications

Corporate law compliance support experience
VLOOKUP function
Statistics
Risk management compliance audits
Data visualization software proficiency
Investigations regulatory compliance
Microsoft Outlook
Medical law
Writing skills
Incident management software
Privacy law
Business intelligence report generation
Trend analysis
Audit Reporting
Documentation tools
Business intelligence tools
Bachelor's degree
Smartsheet
SharePoint
Internal compliance assessments
Data-driven problem-solving
Presentation preparation
Investigating compliance violations
Healthcare ethical conduct investigations
Data visualization projects
Project stakeholder communication
Stakeholder relationship building
FDA regulations
Data analysis software

Full Job Description

California, US residents .

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.

Apply Now

Refine Your Search

compliance monitoring manager jobs

Senior Corporate Compliance Manager – Monitoring

Manager, Privacy Compliance

Patient Access & Pre-Access Supervisor

RN Weekend Supervisor - Groves Center-3K Retention Bonus

Technical Services Manager

Mechanical Building Automation Systems Project Manager

Safety Manager, Reno Arena at GSR

NAM Technical Manager

Civil Engineering Project Manager

Clinical Operations Manager (Nurse Practitioner)

Abalone Division Manager

Nurse Manager (RN)- Night Shift

Clinical Psychologist Supervisor

SQF Manager

Maintenance Manager

Environmental Health and Safety Manager

Maintenance Manager

Family Centered Treatment (FCT) Supervisor

Home Health Quality and Education Manager

Patient Care Manager 3D/3E/Burn

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