• Design, implement, and scale Praxis’s commercial compliance program in advance of first launch, including policies, SOPs, governance, risk assessment, monitoring and training. • Establish launch-ready corporate compliance controls supporting commercial operations. • Serve as a standing MLR member, providing regulatory, legal, and compliance review of promotional materials. • Ensure alignment with FDA regulations, OPDP guidance, and company standards. • Partner with Commercial and Medical teams to enable efficient, compliant review and messaging. • Define MLR processes, timelines, precedents, and escalation pathways. • Train internal stakeholders on promotional compliance, scientific exchange, and appropriate data use. • Advise on compliant use of clinical, safety, and real-world data across promotional and non-promotional channels. • Conduct launch-focused compliance risk assessments and implement monitoring activities. • Support investigation and remediation of commercial compliance issues in partnership with Legal and HR.