Title: Corporate Compliance Counsel
Location: San Rafael, CA
- The purpose of the Temp Compliance Counsel position is to assist the Executive Director, Global Compliance & Ethics in implementing, updating, monitoring, and enforcing the compliance policies and processes of client. and its subsidiaries’ (collectively referred to as ) as part of the Global Compliance Program
- Support the development, implementation, and maintenance of GCP activities, including counseling and training on compliance policies, advertising/promotion and anti-bribery/anti-corruption laws, healthcare compliance regulations, privacy, and transparency/aggregate spend regulatory requirements.
Draft memoranda providing legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, and false claims act statutes) implicated by proposed or existing business strategies.
- Assist the Executive Director in counseling internal brand teams regarding the aforementioned compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA ) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations.
- Assist with the review and analysis of advertising and promotional initiatives, pipeline products/clinical trial recruitment materials, grants/donations and sponsorships, government price reporting and related research on FDA/OIG enforcement activities.
Work with internal functional areas to provide advice and counsel, ensure appropriate/adequate training, engage in monitoring, and support adherence to policies/procedures relating to compliance matters.
- Assist with memorializing and communicating regulatory intelligence regarding new enforcement and emerging laws and regulations applicable to pharmaceutical/biotechnology compliance, along with recent industry trends and changes.
- Minimum of 3 years of experience practicing law or working in the pharmaceutical/healthcare compliance field.
- Experience with and/or understanding of compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
- Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in OIG Guidance and the Federal Sentencing Guidelines.
- Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues, OIG and other industry guidance documents, FDA regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act.
- Demonstrated effectiveness operating in complex organizational and regulatory environments.