Gilead is seeking a talented midlevel attorney to provide product and compliance counsel for Gilead's Hepatitis B therapeutic area within the U.S. as part of the Global Therapeutic Area Legal (GTAL) team. This position will support multiple client groups, including teams within Gilead's Marketing, Sales, Medical Affairs, and Public Affairs departments, providing advice on matters related to promotional and educational activities, engagements with healthcare providers and entities, and other applications of commercial law and regulatory compliance in the biotech/pharmaceutical industry. This position requires a problem-solving mindset, a high degree of collaboration with internal clients and colleagues, and the ability to exercise mature and reliable judgment while enjoying the company's enthusiastic, informal and fast-paced environment.
- Provide advice, guidance and counsel to commercial, medical and corporate teams on sales and marketing strategies, programs, policies, practices and initiatives with respect to compliance with relevant healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance Documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, OIG Advisory Opinions, FCPA, etc.).
- Serve as the legal representative on cross-functional therapeutic area Promotional Review Committees to provide legal feedback and direction on advertising, promotional and educational materials submitted for review.
- Provide legal and compliance training to field and home office Gilead personnel and external consultants, including large group public speaking.
- Review and provide legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations.
- Support execution of a robust healthcare compliance program, including creation and enforcement of Business Conduct policies and procedures, risk assessments and ongoing monitoring.
- Juris Doctorate from a nationally recognized law school.
- Be a member in good standing of the State Bar of California, or have the ability to acquire status of Registered In-House Counsel from the California Bar within 90 days.
- 4 – 6 years of experience with a law firm that has a nationally recognized FDA/Life Sciences practice and/or equivalent experience as a member of a biotechnology or pharmaceutical company's legal department.
- Experience as a commercial lawyer providing legal advice and support for FDA-approved marketed products or equivalent.
- Exceptional and demonstrated written and verbal communication skills.
- Willingness to travel periodically within the U.S.
- Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Workshare, experience with document management systems, Veeva, DocuSign, Internet).
- Demonstration of and willingness to uphold Gilead's core values: Integrity, Teamwork, Accountability, Excellence and Inclusion.
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