Legal Counsel, Therapeutic Area Products

Roche • South San Francisco, CA

8d • $181,800 - $337,600 • Onsite

About The Position

Genentech is hiring a Legal Counsel, Therapeutic Area Products, based at the Genentech campus and part of the Roche Global Legal Pharma group. As a key partner and business strategist, this individual contributor provides U.S. and global legal advice and support throughout the lifecycle of Roche/Genentech’s growing portfolio of innovative medicines. Supported teams include global product strategy, product sales and marketing, commercial strategy and operations, regulatory, market access, U.S. medical affairs, government affairs, and certain global teams.

The role advises on legal and regulatory matters affecting the commercialization of biotech products, supports product lifecycle and cross-functional initiatives, and helps develop business strategies and solutions-oriented approaches to risk. It also advises on transactions, regulatory submissions, label negotiations, privacy and data use, and relationships with healthcare professionals, patients, customers, and government entities. The position develops and delivers compliance training, works with co-promotion partners’ legal counsel, and contributes to business and Legal teams, committees, and other advisory or project groups.

The position is located at Roche’s Genentech campus in South San Francisco, California. It is not eligible for a fully remote working arrangement, and relocation benefits are not available. The role may require early morning or late evening calls to accommodate global time zones and necessary international travel.

Requirements

• Advanced law degree (JD).
• Currently licensed to practice law in good standing in at least one U.S. state.
• Registered or currently eligible as a Registered In-House Counsel in California.
• At least 5 years of legal counseling work experience in-house or at a law firm.
• 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 life sciences, biotech, or pharmaceutical industries.
• Excellent oral and written communication skills.
• Ability to work collaboratively as part of teams in global, matrixed environments.
• Ability to influence without authority and present complex information to senior leaders.
• Adaptability for possible early morning or late evening calls to accommodate global time zones.
• Willingness to undertake necessary international travel.

Nice To Haves

• Experience counseling on therapeutic-area product support for biotech or pharmaceutical clients.

Responsibilities

• Provide advice, education, training, and legal direction on healthcare fraud and abuse laws, pricing, access, FDA labeling and promotional matters, cGMP compliance, products liability, antitrust, privacy, and other laws affecting commercialization of biotech products.
• Serve, as applicable, as lead legal counsel for product lifecycle and cross-functional product- or therapeutic-area-focused business teams and initiatives.
• Advise on business strategies, tactical plan development and implementation, and other business issues, including legal assessments and solutions-oriented risk mitigation strategies.
• Advise on transactions supporting external collaborations and partnerships.
• Advise regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations, privacy, and data use.
• Counsel on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, organized customers, and government entities.
• Develop and implement training for internal clients, partners, and stakeholders on healthcare and related legal compliance policies, procedures, practices, requirements, and current enforcement trends.
• Liaise and negotiate with co-promotion partners’ legal counsel to support successful partnership outcomes.
• Identify opportunities to create value for the business and Legal colleagues, manage legal issues, foster strong client and Legal relationships, establish efficient processes, advise senior business leaders, and serve as a standing or ad hoc member of business or leadership teams.
• Participate in, lead, or present to Company committees and other advisory, project, or work teams.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits; details are provided through a linked benefits resource.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree