Compliance Attorney

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com

You Will:

Maintain a current working knowledge of the various laws, regulations, best practices and industry guidance relevant to the compliant commercialization of, and to interactions and relationships with healthcare organizations and professionals regarding, in vitro diagnostic devices, medical devices, and clinical laboratory services. This includes knowledge of federal and state Sunshine Acts, Federal Anti-kickback Statute, False Claims Act, the OIG and DOJ guidelines, Advanced Medical Technology Association codes, US state and local marketing compliance laws and recent government enforcement actions.

Lead the compliance function within Legal, including helping establish policies with respect to US healthcare compliance, anti-bribery and anti-corruption. Establish and operationalize compliance SOPs.

Support the commercial operations, including product launches and related activities.

Establish and periodically update policies, procedures, training, and monitoring in relation to interactions with healthcare professionals and other third parties, to ensure they appropriately reflect relevant legal and regulatory requirements; implement training in a manner that ensures understanding and applicability of requirements.

Partner closely and interact effectively with internal clients (e.g., Medical Affairs, Commercial) to understand business challenges and provide compliance guidance, counseling, and solutions to address the challenges;

Implement an internal audit, investigations and monitoring function. Coordinate the development and implementation of corrective actions as required.

Ensure the proper review of sponsored activities and donation.

Review and update Code of Conduct to ensure continuing relevance in providing guidance to management and employees.

Perform Risk Assessments to identify areas of potential compliance vulnerability and risk, develop and implement corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.

Institute and maintain an effective compliance communication program for the organization, including

promoting: (a) use of the compliance hotline; (b) heightened awareness of Code of Conduct, and (c) understanding of new and existing compliance issues and related policies and procedures.

Provide guidance on promotional and non-promotional practices under statutory and regulatory requirements as well as Grail internal policies.

Assist in the monitoring of Grail-organized or Grail-sponsored commercial and medical events and activities, as well as ensuring that the necessary documentation is produced, kept and maintained, and reviewing promotional and non-promotional materials relating to commercial and medical event.

Advise on ex-US healthcare compliance requirements.

Provide legal support and guidance on the company-wide data privacy program. Serve as a trusted resource for privacy related matters and maintain a working knowledge of data privacy and security laws in the US and abroad.

Your Background Will Include:

U.S. Law degree required

7+ years of relevant experience in-house in the life sciences industry or law firm.

Excellent verbal and written interpersonal communication and relationship management skills.

Exceptional organizational and planning skills and a meticulous attention to detail.

Ability to effectively prioritize and multi-task.

Excellent analytical and problem solving skills.

Self-motivated and able to work in a self-guided manner while exercising initiative, flexibility and good judgment.

Team player.

Strong desire to improve processes and grow.