Provide legal counsel on the design, implementation, and oversight of patient support programs, including copay assistance, HUB services, reimbursement support, and services for high-cost and biologic therapies.
Advise on Fraud & Abuse risk management (including Anti-Kickback Statute, FCA, and related laws) as applied to patient support and access programs.
Review and assess program structures, vendor arrangements, and patient-facing services (e.g., injection support, access services) to ensure compliance with applicable federal and state requirements.
Partner cross-functionally with Commercial, Market Access, Compliance, and Patient Services teams to support compliant execution of patient access initiatives.
Requirements
Direct, hands-on experience advising on patient support programs within a pharmaceutical or biotech company.
Strong background in Fraud & Abuse laws and their application to copay assistance, HUB services, and reimbursement support programs.
Experience working within large pharmaceutical manufacturer infrastructures or similarly complex patient support environments.
Actively licensed and in good standing in a U.S. state.