Health Care Attorney in Hayward, CA

Profile

Corporate Healthcare Compliance Officer Duties: Oversees the Corporate and Healthcare Compliance Programs, functioning as an independent and objective entity that reviews, evaluates, mitigates and audits compliance issues/concerns within the organization. Reporting to the General Counsel (with a dotted line to the CEO), the position ensures that appropriate compliance measures and controls are in place to align with and support the requirements of industry laws, rules, regulations and guidance. 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. Establishing, maintaining and leading an effective compliance program 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, identify potential areas of compliance vulnerability and risk, provide guidance and advice on compliance issues and mitigation of compliance risks. Collaborate with other departments to ensure compliance issues are identified, evaluated and addressed. Liaise with counsel and other consulting resources as necessary to help ensure the company maintains an effective compliance program. Prepare and submit federal and state reports regarding company's healthcare compliance and marketing activities in a timely manner.

Qualification and Experience

Qualifications: J.D. / MBA or healthcare specialty is a plus. 4 year college degree required. 10 years or more) with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry required. Knowledge and understanding of the required elements of a compliance program as outlined in the US Federal Sentencing Guidelines, the Anti-Kickback Statute, the False Claims Act, FDA rules and regulations, OIG and other industry guidance, and other issues affecting the development, sales and marketing of pharmaceutical products. Must have served in a compliance leadership role and demonstrated experience in building a compliance program.

Company info