Senior Director, Healthcare Compliance
$250,000 - $280,000
Apply (opens in a new tab)Senior Director, Healthcare Compliance
Posted 40 days ago
SENIORITY
Manager
SALARY
$250,000 - $280,000
About the role
- (including, but not limited to):Define and lead the Compliance & Ethics strategy for the Commercial organization, as well as other key business areas, aligning compliance priorities with Company growth, product lifecycle, and market expansion.
- Serve as the accountable Compliance & Ethics business partner for Commercial, as well as Medical Affairs, Patient Services, and Patient Advocacy.
- Represent Compliance & Ethics in cross-functional leadership discussions, proactively embedding compliance into business planning.
- Design and help build scalable compliance processes and procedures to support future product launches and geographic expansion.
- Proactively identify, assess, and advise on mitigation of compliance risks across external-facing business activities.
- Provide clear, actionable guidance on complex topics, including: Engagements with Healthcare Professionals (HCPs), sponsorships, grants, and charitable contributions, patient support programs, patient advocacy group interactions, market access and emerging commercialization models
- Partner with Commercial leadership to design processes and procedures that enable compliance.
- Oversee the development, implementation, and effectiveness of Compliance & Ethics policies, standards, and governance for Commercial, as well as other external-facing business areas.
- Provide input into the development and implementation of a risk-based monitoring and auditing program, leveraging data and analytics.
- Ensure healthcare compliance requirements are addressed in other program activities, including but not limited to: Risk assessments, third-party due diligence, fair market value, and tiering of HCPs, and needs assessments
- Act as a visible and trusted compliance leader, fostering a "speak-up" culture.
- Provide guidance on key regulations, standards, and industry codes, including but not limited to: Anti-kickback laws, False Claims Act, Fraud & abuse laws, U.S. Department of Justice (DOJ) and U.S. Health & Human Services Office of Inspector General (OIG) Compliance Program Guidance, PhRMA Code
- Standout Skills for Impact:
- Maintain deep expertise in applicable laws and monitor external compliance developments within the pharmaceutical industry
- Drive innovation in compliance operations through technology, automation, and process improvement
- Champion a culture of transparency, ethical decision-making and accountability across Commercial, as well as other key external-facing business areas
- Together with other Compliance & Ethics team members, lead the development of role-specific, risk-based training and awareness programs that drive behavior change
- 10+ years in pharmaceutical/biotech compliance
- Experience advising or serving as a compliance business partner to the Commercial organization (e.g., Sales, Marketing, Thought Leader Liaisons).Strong knowledge of U.S. Anti-Kickback Statute, U.S. False Claims Act, PhRMA Code, OIG guidance, and applicable state regulations.
- Experience providing compliance guidance regarding HCP engagements, grants, sponsorships, and patient support programs.
- Track record of successfully building or scaling compliance and ethics programs.
- Excellent communication and prioritization skills, with an ability to work in a collaborative, cross-functional environment.
- B.A./B.S. degree required
- Willingness to travel up to 25%Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
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