Job Summary

The Director, Healthcare Compliance is responsible for leading and operating the Company's healthcare compliance program and promoting a culture of ethics, integrity, and compliance across the organization. Reporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions.

The Director is responsible for designing, implementing, monitoring, and continuously improving an effective healthcare compliance program consistent with OIG Compliance Program Guidance, applicable federal and state healthcare laws, FDA regulations, industry codes, and Company policies. This is a highly visible, hands-on leadership role responsible for executing key aspects of the compliance program, including risk assessment, training, monitoring, investigations, transparency reporting, and compliance governance. The Director will partner closely with business leaders across the organization and may oversee compliance personnel and external resources as the function evolves.

The Director will work closely with the Associate General Counsel on healthcare regulatory matters, investigations, policy development, compliance monitoring activities, and legal-compliance risk assessments.

Core Responsibilities

Program Leadership
• Lead all aspects of the healthcare compliance program.
• Develop and execute annual healthcare compliance strategy and work plan.
• Conduct enterprise healthcare compliance risk assessments.
• Maintain compliance policies, standards, procedures, and controls.
• Develop compliance metrics and key performance indicators.

Compliance Governance
• Administer Healthcare Compliance Committee activities.
• Prepare reports for Executive Leadership, Compliance Committee, and Board committees.
• Escalate significant compliance risks and investigations.
• Serve as the primary compliance advisor to the Chief Compliance Officer and provide regular updates regarding compliance program effectiveness, emerging risks, investigations, and remediation activities.

Commercial and Medical Compliance
• Serve as a core member of the MLR review process.
• Advise on promotional materials and promotional claims.
• Support launch and lifecycle compliance activities.
• Provide guidance regarding speaker programs, advisory boards, consultants, grants, charitable contributions, sponsorships, and other healthcare professional engagement activities.

HCP/HCO Interactions

Provide oversight of:
• Anti-Kickback Statute compliance
• False Claims Act risk mitigation
• Sunshine/Open Payments reporting
• State transparency laws
• Fair Market Value (FMV) assessments
• Needs assessments
• Engagement documentation and controls

Monitoring and Auditing
• Develop annual monitoring plan.
• Conduct and oversee monitoring reviews.
• Recommend and track corrective action plans.
• Analyze trends and emerging compliance risks.

Investigations
• Lead healthcare compliance investigations.
• Partner with Human Resources and Legal, when appropriate.
• Ensure appropriate documentation, remediation, and CAPAs.

Training and Communications
• Create risk-based compliance training programs.
• Deliver live training to commercial, medical, and cross-functional teams.
• Maintain compliance communications and awareness initiatives.

Compliance Leadership & Execution
• Serve as a hands-on compliance leader responsible for both strategy development and program execution.
• Personally conduct and oversee key compliance activities, including risk assessments, monitoring, investigations, training, and governance reporting.
• Influence and lead cross-functional stakeholders without direct reporting authority.
• Coordinate external advisors and consultants to support specialized compliance initiatives.
• Build and scale the healthcare compliance function and team as business needs evolve.

Qualifications
• Bachelor's degree required.
• JD, MBA, PharmD, MSN, or equivalent advanced degree preferred.
• 10+ years of pharmaceutical, biotechnology, healthcare, or healthcare compliance experience.
• 5+ years leading healthcare compliance programs, initiatives, or teams in a pharmaceutical, biotechnology, or healthcare organization.
• Deep expertise in:

o FDA promotional regulations

o Anti-Kickback Statute

o False Claims Act

o Sunshine/Open Payments

o OIG Compliance Program Guidance

o PhRMA Code

o State healthcare compliance requirements
• Experience leading audits, investigations, training, monitoring, and compliance risk management programs.
• Significant MLR review experience.
• Demonstrated ability to independently build, implement, and operate healthcare compliance programs in a pharmaceutical, biotechnology, or healthcare environment.
• Strong business partnering, communication, and influencing skills with demonstrated ability to engage effectively with executive leadership and cross-functional stakeholders.
• Proven ability to manage multiple priorities in a dynamic growth environment.

Reporting Relationship
• Solid-Line Reporting: Chief Legal Officer & Chief Compliance Officer
• Dotted-Line Reporting: Vice President, Associate General Counsel
• Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership
• Direct Reports: None initially; future compliance personnel may be added as the compliance function evolves.

Position Profile

This role is designed to be the Company's senior healthcare compliance leader and primary compliance subject matter expert. The position combines strategic oversight with direct operational responsibility and requires a professional who can independently build, implement, monitor, and continuously improve an effective healthcare compliance program. Success in the role will depend on sound judgment, strong cross-functional influence, deep healthcare compliance expertise, and a willingness to operate as a hands-on leader while helping scale the compliance function as the organization grows.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.