Director, US Compliance
Revolution Medicines · San Francisco Bay Area · 2 wk ago
HybridManagement$267k–$306k/yrFull-time
Key Responsibilities
- Provide timely, practical, and risk-based compliance advice and counsel on healthcare compliance and policy requirements related to Revolution Medicines interactions with the healthcare community, including disease education programs, promotional and non-promotional activities, consulting engagements, advisory boards, external funding, patient assistance programs, patient advocacy group interactions, payer interactions, and other similar activities.
- Support the review and approval of promotional and non-promotional materials and patient engagement programs to ensure regulatory compliance.
- Advise on compliance with False Claims Act, Anti-Kickback Statute (AKS), Foreign Corrupt Practices Act (FCPA), and state/federal transparency laws.
- Collaborate with Healthcare Law Partner closely to ensure consistency between legal interpretation and compliance operations.
- Maintain a clear functional separation of responsibilities between Compliance and Healthcare Law.
- Collaborate to deliver integrated, practical, and risk-appropriate guidance to internal clients – particularly within Commercial, Medical Affairs, Clinical Development, and Market Access functions.
Compliance Risk Assessments, Investigations, and Mitigation
- Identify and escalate compliance risks, and support development of mitigation strategies.
- Conduct compliance risk assessments related to commercial and medical activities, external stakeholder engagements, and other business activities.
- Lead investigations into potential compliance violations, ensuring timely, thorough resolution and corrective actions.
- Support implementation of corrective and preventive actions resulting from monitoring or audit activities.
Training, Communications, and Compliance Program Support
- Support operational execution of healthcare compliance policies and processes.
- Develop and implement risk-based compliance training tailored to various business functions and levels within the organization.
- Promote a culture of ethics and compliance through ongoing communications and awareness initiatives.
- Collaborate with internal stakeholders to identify process improvements and enhance operational efficiency.
- Participate in compliance monitoring, auditing, and remediation activities, as needed.
Governance & Reporting
- Assist in preparation of materials and reporting for Compliance Committee and senior leadership.
- Support development and implementation of policies, procedures, and controls designed to mitigate compliance risk while supporting business needs.
- Absorb data analytics to manage compliance risks.
- Contribute to the development of annual compliance work plans and strategic priorities.
- Monitor evolving regulatory and industry developments and assess impact on company policies and practices.