Life Sciences companies, especially start-ups, cannot jeopardize their hard earned successes and multi-million dollar investments with compliance failures.I protect against such failures by applying a unique blend of legal and compliance-focused experience in corporate, law firm, government, and consulting roles, coupled with my strategic perspectives and insights. Moreover, I emphasize collaborating with varied business partners to achieve clear business-minded goals. I take both a strategic and business-aligned perspective, always mindful of government enforcement and oversight. My areas of expertise include:- Health Care Fraud & Abuse/FDA Regulations/False Claims Act/Anti-Kickback Statue - Advised commercial and medical affairs functions regarding interactions with healthcare professionals (Ad Boards, Consulting Engagements, Grants, Meals, Speaker Programs, etc) - Provided oversight and governance for ad/promo review processes to address off-label promotion risks - Designed, implemented, managed and trained on policies and procedures to address primary compliance risks (e.g., healthcare professional interactions, off-label promotion) - Ensured compliance programs incorporate industry codes of conduct (e.g., PhRMA, AdvaMed), as appropriate - Compliance Program Leadership, Development, Implementation, Assessment
- Built, evolved and led compliance program structures, reporting relationships, information flows, committees, and processes - Assessed and enhanced compliance programs - Incorporated Federal Sentencing Guidelines/OIG-DOJ Compliance Guidances, as appropriate - Compliance Investigations - Conducted and resolved internal compliance investigations and recommend disciplinary actions as well as implement corrective action measures, as appropriate - Partnered with HR and Legal in conducting investigations, as appropriate - People Management -Built and led compliance teams scaled appropriately for business needs and risk profile -Developed and supported career growth paths for team members- Government Enforcement - Utilized government enforcement background to assess internal risks and build programs as well as advise organizations, accordingly - Partnering with Legal, strategized on development of internal responses
- Due Diligence/Acquisitions -Managed due diligence and integration on compliance in acquisitions for both the acquiring entity in several instances and acquired entity in two instance
Listed skills include Compliance, Ethics, Medical Devices, Life Sciences, and 19 others.