Job Details

Health Care Attorney in Santa Monica CA

Organization Type

In-House

Job Type

Attorney

Posted on

Sep 11,2019

Years of Experience

Min 6 yrs required

Location

Santa Monica, CA, United States
Practice Area
Health Care >> Health Care
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Senior Counsel II, Commercial Legal/Business Conduct
The candidate will report to the Senior Counsel II. Will act as designated brand attorney for one of company's marketed or investigational products, providing a full range of healthcare compliance advice and support to the company's Marketing and field-based teams and cross-functionally. Provide senior management with effective legal advice on all healthcare compliance matters, contribute to the management of the Commercial Legal/Business Conduct team and the larger company Legal function, and instruct and oversee the work of outside counsel when needed. Participate in strategic decision making with a broad range of functional groups within the company. Provide advice, guidance and counsel to Commercial, Medical, Regulatory and other relevant functions on management and marketing strategies, programs, policies, practices and initiatives (including review of slide decks and other internal and external communications) 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 the cross-functional therapeutic area Promotional Review Committee for one marketed or investigational product and to provide legal advice and guidance on advertising, promotional and educational materials submitted for review. Attend as Legal representative external scientific congresses and internal company meetings and provide legal and compliance training to field and home office 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. Act as primary legal advisor to such teams or functions as the Executive Director shall direct from time to time. Support the development and implementation of a robust healthcare compliance program within company, including creation and enforcement of Business Conduct policies and procedures, risk assessments and ongoing monitoring.

Qualification and Experience

The candidate should have a J.D. degree from a nationally recognized law school and be admitted to practice, preferably in California. BS in life sciences or related field is preferred. Must have 6+ years of experience in a law firm and/or in-house in the biotechnology or pharmaceutical industry advising clients on both business and legal issues. Prior experience with or exposure to regulatory processes for pharmaceutical products and laws, and regulations governing pharmaceutical/biological products is required. Should have in-depth experience with the biotech or pharmaceutical industries, including business operations and regulatory framework. Must have willingness and ability to work with and coordinate activities across a large number of individuals across various departments, throughout the company's domestic and international subsidiaries in Europe, Latin America and Asia.

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