/ Hiring

Senior Corporate Counsel or Assistant General Counsel

South San Francisco, California

Job ID: 00413256

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

The Senior Corporate Counsel or Assistant General Counsel (Specialist) 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, development and manufacturing functions. Supported teams include brand sales and marketing teams, commercial strategic and operational functions, and medical affairs and development teams that have human medicines and companion diagnostics in all phases of development, and manufacturing. Specific activities may include the following:

• Providing advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;

• Assisting in structuring tactics and related contracts in compliance with applicable law;
• Serving as lead legal counsel for global development programs and medical affairs initiatives;

• Advising clinical, product development, regulatory, medical affairs, and other clients on good clinical practice, human subject protection, research on human tissue samples, conflict of interest policies, FDA regulatory submissions, label negotiations and privacy and data use;

• Counseling on appropriate relationships with healthcare professionals, patients, managed care entities, academic institutions, and government entities;

• Negotiating agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and

• Drafting and interpreting company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.

Who You Are

The ideal candidate will have a JD with Bar admission from a top tier law school, and Sr Corporate Counsel will have between 7-15 years in practice, including 5+ 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, with a focus on counseling pharmaceutical and/or clinical clients on U.S. and international rules related to the promotion, clinical development, and manufacture of human medicines and companion diagnostics. Eligibility for the Assistant General Counsel (Specialist) title will require a minimum of 15 years of legal practice, with 10+ years of specialized practice in the above areas of law. 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, along with excellent oral and written communications skills. You will join a team that enjoys learning and reaching increasing levels of legal and business competency.

The Healthcare Law Group, as part of the Genentech Law Department, values ongoing professional development and collegiality in support of our vision to be essential partners to our clients, driving business excellence to improve patient lives. We seek and cultivate self-motivated individuals who share this vision and consistently demonstrate excellent judgment, ethics, collaboration, and interpersonal skills.

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.

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Job Facts

Job Function: Management Legal
Location: United States - California
South San Francisco
Company/Division: Pharmaceuticals
Schedule: Full-time
Job type: Regular Employee
Job Level: Experienced