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ProfileDirector / Associate Director, Compliance The candidate will be responsible for developing, implementing and overseeing enterprise-wide compliance initiatives to ensure alignment with business goals and objectives, and adherence to company policies as well as applicable state and federal laws, regulations, and codes. Will report to the Head of Healthcare Law and will collaborate with leaders across all units of the organization, including the Commercial organization, Medical Affairs, IT, HR and Finance. Serve as a compliance subject matter expert responsible for ensuring effective operation of company’s Compliance Program with respect to all key elements of the program: policies and procedures; oversight; training; communication; auditing and monitoring; enforcement; and ongoing risk assessment and remediation. Oversee operations and accountabilities of the Corporate Compliance Committee in accordance with its charter, including reporting compliance updates and issues to the company CEO and Board of Directors. Work with the Head of Healthcare Law, other representatives of the Legal Department and functional leaders throughout the organization to identify and develop strategies to address key compliance risk areas. Draft and drive implementation of policies and/or procedures appropriate to support compliant behaviors. Develop and implement training programs to ensure that company personnel understand and appreciate compliance issues applicable to their roles. Build and maintain communications and access channels appropriate to ensure that all company personnel are aware of and able to use compliance resources including policies, guidances and reporting mechanisms available to raise concerns about noncompliance. Lead key compliance initiatives including auditing and monitoring activities to assess needs for corrective actions and/or additional training or resources. Implement necessary corrective action plans for resolution of problematic issues and provide guidance on how to address and prevent repetition of noncompliant behavior. Monitor external trends and educate company personnel with regard to compliance risk areas and government enforcement of laws affecting company’s business operations. Prior experience in Pharma/Biotech industry required. Should have Four-year degree plus 8-12 years of compliance/legal experience. Law Degree with core practice experience counseling clients related to healthcare, pharmaceutical or medical device industry compliance matters preferred. Experience or familiarity with general corporate compliance issues affecting a publicly-traded company operating in California (insider trading, FCPA, sexual harassment) desired. Knowledge and understanding of pharmaceutical industry regulations and guidelines for compliant product development and commercial operations (e.g. GMP, GCP, PhRMA Code, federal kickback prohibition, False Claims Act, FD&CA) preferred.
7000 Shoreline Court
South San Francisco, CA 94080