Manager/Sr. Manager, US Compliance

Role: Build and lead the US healthcare compliance program from the ground up ahead of first commercial launch, ensuring readiness across legal, regulatory, and operational domains. Responsibilities: develop policies, controls, training, and frameworks supporting compliance with the Anti-Kickback Statute, False Claims Act, FDA advertising regulations, PhRMA Code, and OIG guidance; prepare for launch with assessments of promotional activities; establish processes for HCP engagement, transparency, aggregate spend reporting, and risk monitoring; serve as a day-to-day advisor to US commercial and medical teams. Requirements: Bachelor's degree, 3-5+ years pharma/biotech compliance experience supporting US product launches; practical knowledge of speaker programs, advisory boards, fair market value, grants, and promotional regulations; familiarity with relevant US healthcare laws and reporting obligations; strong communication skills and stakeholder influence. Preferred: compliance certifications (e.g., CCEP, CHC). HighValue: US compliance, pre-launch readiness, biotech/pharma industry, smaller/scaling organization experience, remote work with some travel, responsibilities spanning policy design, risk assessment, training, and cross-functional collaboration.