Associate Corporate Compliance Director - Commercial & Medical Affairs

at United Therapeutics in Augusta, Maine, United States

California, US residents click here ( UNITHER %20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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 daughters 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 Associate Corporate Compliance Director reports to the Senior Corporate Compliance Director and serves as a key compliance business partner to Commercial and Medical Affairs, including Sales, Marketing, Commercial Training and Development, Patient Advocacy, and Medical Affairs. This role partners closely with senior leadership to drive the development and execution of the Commercial and Medical Affairs compliance strategy, ensuring alignment with evolving regulatory expectations and business objectives. The Associate Director is responsible for overseeing day-to-day compliance activities while shaping proactive, risk-based approaches to support the business. The role provides strategic and operational leadership across core compliance activities, including guidance and advisory support, role-based training, monitoring, and issue resolution. The Associate Director is expected to influence business decision-making, identify emerging risks, and implement solutions that enable compliant growth. This role influences strategy to address internal and external business and regulatory dynamics, with direct impact on the companys strategic direction and alignment with its therapeutic focus areas.

COMPLIANCE BUSINESS PARTNERING & SUPPORT

Serve as a Compliance business partner supporting Commercial and Medical Affairs activities (e.g., speaker programs, advisory boards, exhibits, educational grants, etc.), providing strategic and day-to-day advisory support

Provide timely, solutions-oriented guidance to Commercial and Medical stakeholders on complex and nuanced compliance matters

Drive implementation and evolution of the Commercial and Medical Affairs compliance strategy in alignment with senior Compliance leadership

Anticipate and proactively identify internal and external business challenges and regulatory risks, developing and recommending practical, risk-based solutions

Build and maintain strong, trusted relationships with cross-functional stakeholders, promoting a proactive, partnership-driven approach to Compliance

Serve as a recognized subject matter expert, providing guidance across the organization and influencing decision-making

Assess and escalate high-risk, novel, or complex compliance issues to senior Compliance leadership, as appropriate, with clear recommendations

Actively contribute to and influence cross-functional teams and business discussions to ensure Compliance perspectives are integrated into decision-making

Foster stakeholder engagement and visibility across Commercial and Medical Affairs through active partnership (e.g., field engagement, meetings, and business interactions)

POLICIES & PROCEDURES

Partner with the Training, Policy, and Communications team to support the development, implementation, and ongoing enhancement of Compliance policies, procedures, and related resources supporting Commercial and Medical Affairs

Ensure policies are aligned with evolving regulatory requirements and business needs, proactively identifying gaps and driving updates as appropriate

Translate policy requirements into clear, practical guidance to enable consistent and compliant execution by business stakeholders

Drive awareness and adoption of policies through effective communication and integration into business processes

TRAINING & COMMUNICATION

Partner with the Compliance Training & Communications function to shape and continuously enhance training and communication strategies for Commercial and Medical Affairs

Ensure training content reflects evolving policies, emerging risks, and business priorities, providing subject matter expertise and direction to drive relevance and impact

Design and deliver role-based Compliance training, including live and virtual sessions, with a focus on practical application and business integration

Drive effective communication and reinforcement of key Compliance principles, promoting awareness, retention, and consistent application across the organization

MONITORING & AUDITING

Conduct live compliance monitoring activities for Commercial and Medical Affairs functions

Leverage monitoring insights to inform broader Compliance strategy, training, and policy improvements

Partner with the Auditing and Monitoring team to support the tracking, follow-up, and resolution of compliance findings, providing subject matter expertise and recommending appropriate remediation actions (e.g., coaching, training, policy enhancements)

RISK ASSESSMENT

Partner in the execution of risk assessment and mitigation activities for Commercial and Medical Affairs, ensuring alignment with the broader Compliance Risk Assessment framework

Provide subject matter expertise to identify, assess, and prioritize key compliance risks, contributing meaningful input to risk mitigation strategies

Identify opportunities to strengthen compliance processes and controls, and drive continuous improvement in partnership with cross-functional stakeholders

OTHER

Lead and manage complex, cross-functional projects and initiatives with significant scope, risk, and organizational impact

Provide input into the design and execution of Compliance strategy, influencing organizational practices, policies, and systems

Promote a culture of compliance and accountability by raising awareness and reinforcing expectations across the organization

Mentor and develop team members, contributing to capability building across the Compliance function

Minimum Requirements

+ Bachelors 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,

+ Masters Degree with 10+ years of relevant experience in the life sciences industry (pharmaceutical, medical device or biotech)

+ Life sciences background: pharmaceutical, medical device or biotech

+ Ability to build strong, professional relationships with internal stakeholders

+ Ability to work in a fast-paced environment while demonstrating flexibility, commitment to teamwork, and a willingness to adapt assignments to meet the Companys needs

+ Demonstrated knowledge of regulatory/compliance requirements, including the Anti-Kickback Statute, False Claims Act, Foreign Corrupt