Director, Healthcare Compliance
Aquestive Therapeutics
August 31, 2026
Remote friendly (Warren, NJ)
United States
Corporate Functions
Responsibilities
- Lead all aspects of the healthcare compliance program; develop and execute annual compliance strategy/work plan.
- Conduct enterprise healthcare compliance risk assessments; maintain compliance policies/standards/procedures/controls.
- Develop compliance metrics/KPIs; administer Healthcare Compliance Committee activities; report to executive/committee/board.
- Escalate significant risks/investigations; advise the Chief Compliance Officer on effectiveness, emerging risks, investigations, and remediation.
- Serve as a core member of the MLR review process; advise on promotional materials/claims; support launch and lifecycle compliance.
- Provide guidance on speaker programs, advisory boards, consultants, grants, charitable contributions, sponsorships, and HCP engagement.
- Oversee: Anti-Kickback Statute compliance, False Claims Act risk mitigation, Sunshine/Open Payments reporting, state transparency laws, FMV assessments, needs assessments, and engagement documentation/controls.
- Develop and execute annual monitoring plan; conduct monitoring reviews; track corrective action plans; analyze trends/emerging risks.
- Lead healthcare compliance investigations; partner with HR/Legal as appropriate; ensure documentation, remediation, and CAPAs.
- Create and deliver risk-based compliance training; maintain compliance communications/awareness.
- Coordinate external advisors; build/scale the compliance function/team as needed.
Qualifications
- Bachelor’s degree required; JD/MBA/PharmD/MSN (or equivalent) preferred.
- 10+ years in pharma/biotech/healthcare/compliance; 5+ years leading healthcare compliance programs/initiatives/teams.
- Expertise in FDA promotional regulations, Anti-Kickback Statute, False Claims Act, Sunshine/Open Payments, OIG Compliance Program Guidance, PhRMA Code, and state healthcare compliance.
- Experience with audits, investigations, training, monitoring, and compliance risk management; significant MLR review experience.
- Strong business partnering, communication, influencing, and ability to manage multiple priorities.
Compensation
- Expected salary range: $175,000–$200,000/year.
Application Instructions
- Final candidate must complete a drug test and background check prior to employment.
- Lead all aspects of the healthcare compliance program; develop and execute annual compliance strategy/work plan.
- Conduct enterprise healthcare compliance risk assessments; maintain compliance policies/standards/procedures/controls.
- Develop compliance metrics/KPIs; administer Healthcare Compliance Committee activities; report to executive/committee/board.
- Escalate significant risks/investigations; advise the Chief Compliance Officer on effectiveness, emerging risks, investigations, and remediation.
- Serve as a core member of the MLR review process; advise on promotional materials/claims; support launch and lifecycle compliance.
- Provide guidance on speaker programs, advisory boards, consultants, grants, charitable contributions, sponsorships, and HCP engagement.
- Oversee: Anti-Kickback Statute compliance, False Claims Act risk mitigation, Sunshine/Open Payments reporting, state transparency laws, FMV assessments, needs assessments, and engagement documentation/controls.
- Develop and execute annual monitoring plan; conduct monitoring reviews; track corrective action plans; analyze trends/emerging risks.
- Lead healthcare compliance investigations; partner with HR/Legal as appropriate; ensure documentation, remediation, and CAPAs.
- Create and deliver risk-based compliance training; maintain compliance communications/awareness.
- Coordinate external advisors; build/scale the compliance function/team as needed.
Qualifications
- Bachelor’s degree required; JD/MBA/PharmD/MSN (or equivalent) preferred.
- 10+ years in pharma/biotech/healthcare/compliance; 5+ years leading healthcare compliance programs/initiatives/teams.
- Expertise in FDA promotional regulations, Anti-Kickback Statute, False Claims Act, Sunshine/Open Payments, OIG Compliance Program Guidance, PhRMA Code, and state healthcare compliance.
- Experience with audits, investigations, training, monitoring, and compliance risk management; significant MLR review experience.
- Strong business partnering, communication, influencing, and ability to manage multiple priorities.
Compensation
- Expected salary range: $175,000–$200,000/year.
Application Instructions
- Final candidate must complete a drug test and background check prior to employment.