VP, Corporate Compliance
Legal and Intellectual Property
- The VP, Head of Compliance oversees the Corporate and Healthcare Compliance Programs, as an independent and objective function that reviews, evaluates, mitigates and audits compliance issues/concerns within the organization. Such corporate compliance function does not include QA/manufacturing or SOX compliance which are handled by those separate functions. Reporting to the Sr. VP, General Counsel, the position ensures that appropriate compliance measures and controls such as policies, procedures, training, monitoring and auditing are in place to align with and support the requirements of industry laws, rules, regulations and guidance, and also has responsible for overseeing and coordinating state licensing, manufacturing/wholesale distribution licensing and state price reporting. The position is also responsible for communicating with and advising the Board of Directors, management and employees as needed to help ensure compliance with all applicable laws, rules and regulations that govern the company's business. The position also manages and oversees a team of direct reports responsible for the above areas.
- Establishing, maintaining and leading an effective compliance program and department in accordance with federal, state and industry regulations.
- Act as independent review and evaluation body to ensure compliance issues/concerns with the company are being appropriately evaluated, investigated, and resolved.
- Assessing and reporting on the current state of compliance of the company to senior management and the Board of Directors, identify potential areas of compliance vulnerability and risk, provide guidance and advice on compliance issues and mitigation of compliance risks.
- Collaborating with other departments to ensure compliance issues are identified, evaluated and addressed. Liaising with counsel and other consulting resources as necessary to help ensure the company maintains an effective compliance program.
- Preparing and submitting federal and state reports regarding company's healthcare compliance and marketing activities in a timely manner. Overseeing and coordinating state licensing, manufacturing/wholesale distribution licensing and state price reporting.
- Managing direct reports who are primarily responsible for reporting, training, monitoring and licensing functions
- Bachelors Degree (BA/BS) four year college degree - Required
- Master Degree (MS/MA) Advanced degree (such as JD or MBA) or healthcare specialty - Preferred
- 12 years or more in Significant experience (12 years or more) with a large to mid-size branded pharmaceutical company with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry, handling corporate and sales force promotional compliance.
- 1 year or more in 1 to 5 years served in a compliance leadership role and demonstrated experience in building a compliance program.
- Excellent written, oral and presentation skills. - Advanced
- Demonstrated ability to work with effectively and collaboratively with all levels of management; strong influencing skills and sound business judgement. - Advanced
- Strong problem solving skills and ability to operate successfully in a cmplex, constantly changing, fast-paced environment. - Advanced
- Demonstrated initiative, proactive approaches, ability to manage a diverse and demanding workload and appropriately prioritize issues. - Advanced
- Communication—Listening and Speaking: Listening • Receive, attend to, interpret, understand, and respond to verbal messages and other cues • Apply active listening skills using reflection, restatement, questioning, and clarification • Pick out important information in verbal messages • Understand complex instructions Speaking/Presenting • Speak clearly and confidently using common English conventions including proper grammar, tone, and pace • Express information to individuals or groups taking into account the audience and the nature of the information (e.g., explain technical concepts to non-technical audiences) • Present ideas in a persuasive manner - Advanced
- Critical and Analytical Thinking: Using logic, reasoning, and analysis to address problems. • Use interdisciplinary skills to integrate knowledge of various academic disciplines to solve problems • Use logic and reasoning to identify strengths and weaknesses of alternative solutions, conclusions, or approaches to problems • Use inductive and deductive reasoning to analyze, synthesize, compare, and interpret information • Draw conclusions from relevant or missing information • Understand the underlying relationship among facts and connections between issues • Organize problems into manageable parts - Advanced
- Demonstrated knowledge and understanding of the required elements of a compliance program as outlined in the US Federal Sentencing Guidelines, the Anti-Kickback Statutue, the False Claims Act, FDA rules and regulations, OIG and other industry guidance, and other issues affecting the development, sales and marketing of pharmaceutcal products.