Note: The job is a remote job and is open to candidates in USA. United Therapeutics Corporation is a publicly-traded biotech company focused on developing novel pharmaceutical therapies and technologies for transplantable organs. The Associate Director, Corporate Compliance - Operations will lead compliance systems, process governance, and reporting enablement to support a modern Corporate Compliance program, while also developing a third-party risk management program.
Responsibilities
- Lead the design and optimization of compliance systems, workflows, and governance structures that support key operational processes such as HCP engagement, external funding, and fair market value
- Responsible for advancing a compliance systems and data roadmap, overseeing enhancements and release readiness, and ensuring that processes remain well controlled, sustainable, and aligned with business and regulatory expectations
- Provide leadership for data governance across compliance-owned systems and datasets by establishing quality standards, definitions, documentation, and control expectations
- Enable more effective reporting and analytics by improving data completeness, accuracy, and usability and by partnering with stakeholders to define business requirements for dashboards, extracts, and other reporting outputs
- Play a leadership role in building and maintaining a third-party risk management program for healthcare compliance risk, including risk-based intake, due diligence, governance, onboarding, renewal, and termination processes
- Partner across functions to embed appropriate compliance controls into vendor lifecycle activities and helps ensure that operational design keeps pace with evolving business needs and regulatory expectations
- Work across functions and levels of the organization to influence decisions, align priorities, and move initiatives forward
Skills
- Bachelor's Degree in business, finance, life sciences, healthcare, information systems or related field with 12+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech) or
- Master's Degree with 10+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech)
- 7+ years of experience leading compliance systems and process governance, requirements definition, testing/UAT, implementation and continuous improvement and making decisions and recommendations regarding organizational practices, policies and systems
- 7+ years of experience with data governance and operational reporting/analytics (e.g., dashboards, KPIs, data quality)
- Ability to build and maintain professional relationships with internal stakeholders
- Demonstrated experience leading highly complex initiatives with significant risk and complexity, leveraging strong cross-functional relationships and influencing skills
- Ability to manage multiple priorities in a fast-paced environment with flexibility, commitment to teamwork, and willingness to adapt assignments to meet the Company's needs
- Ability to partner cross-functionally with IT, Finance, Legal, and business stakeholders to drive adoption and timely delivery of system/process enhancements, including communicating with senior/executive leaders as a functional area expert
- Strong project/program management experience, including managing scope, timelines, risk/issues, and cross functional stakeholders
- Strong analytical and problem-solving skills with strong attention to detail and accuracy; ability to translate complex data/process topics into clear insights and recommendations
- Strong presentation and communication skills (written and verbal), including creation of executive-ready materials and facilitation of working sessions
- Manages sensitive and confidential matters with discretion and sound judgment
- Proficiency with Microsoft Office (Word, Excel, PowerPoint) and familiarity with analytics and work management tools (e.g., Power BI, Smartsheet, Microsoft Project)
- Demonstrated knowledge of regulatory/compliance requirements applicable to corporate compliance (e.g., Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practice Act, and state price transparency laws and regulations)
- Demonstrated ability to design and govern compliance systems and system-enabled processes, including defining controls, translating requirements into system/process configurations, and ensuring sustainable operating procedures
- Strong understanding of data governance concepts and ability to establish data quality standards, definitions, and reporting requirements to support reliable analytics and decision-making
- Learning agility: ability to quickly learn new subject areas and support emerging priorities as directed
- Produces high quality work with minimal oversight from manager
- Ability to travel up to 20%
- Master's Degree in business, finance, life sciences, healthcare, information systems or related field
- 7+ years of experience designing, developing, and leading third-party risk management programs and/or embedding compliance controls into vendor/procurement processes
- CHC - Certified Healthcare Compliance or equivalent healthcare compliance certification
- Working knowledge of artificial intelligence concepts and governance considerations, and ability to use AI tools at a basic level to support productivity and analysis in a professional environment
Benefits
- Medical / dental / vision / prescription coverage
- Employee wellness resources
- Savings plans (401k and ESPP)
- Paid time off & paid parental leave benefits
- Disability benefits
Company Overview
Founded to find a cure for a daughter’s rare disease, United Therapeutics is a biotechnology company transforming care for people with chronic and life-threatening conditions. It was founded in 1996, and is headquartered in Silver Spring, Maryland, USA, with a workforce of 1001-5000 employees. Its website is http://www.unither.com.