Senior Counsel/Assistant General Counsel, Healthcare Law Group

South San Francisco, CA
Full Time
04-21-2019
Job #: 201904-112031 Exp.: 5 - 15 Years
Description:
The Sr. Counsel/Assistant General Counsel will work as part of the Healthcare Law Group within Genentech's Legal department. The position will have the opportunity to provide legal advice and support across the lifecycle of Genentech's products, including commercial, medical affairs, managed care, government affairs and clinical development functions. Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and regulatory, managed care (patient access, pricing and distribution), medical affairs and development teams that have human medicines and companion diagnostics in all phases of development.

Specific activities may include the following:
  • Providing advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, pricing, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
  • Serving as lead legal counsel for product lifecycle and cross-functional product or therapeutic area-focused business teams and initiatives;
  • Advising on business strategies, tactical plan development and implementation, and other business issues, including development of legal assessments and solutions-oriented risk mitigation strategies;
  • Advising clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use;
  • Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, managed care entities, and government entities;
  • Developing and implementing training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance, and on current enforcement trends; and
  • Liaising and negotiating with co-promotion partner’s legal counsel to enable and drive for successful partnership outcomes.

Qualifications:
  • 8-15 years in practice, including 5-7 years of recent relevant legal experience at a law firm with a nationally-recognized FDA/Life Sciences practice or in a pharmaceutical or biotechnology company’s law department
  • Working experience with a focus on counseling pharmaceutical and/or clinical clients on U.S. rules related to the promotion and clinical development of, and post-approval activities related to, human medicines and companion diagnostics.
  • A United States law degree (JD) with Bar admission from a top-tier law school
  • Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries is essential
  • Excellent oral and written communications skills.
  • Demonstrated leadership on cross-functional teams and the ability to be accurate and influential in presenting complex information to all levels of management are also expected of the candidate to be successful in the role.

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