Legal Counsel, Therapeutic Area Product Support

Genentech • Daly City, CA

1d • $181,800 - $337,600 • Onsite

About The Position

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

The position advises on healthcare fraud and abuse, pricing, access, FDA labeling and promotion, cGMP compliance, product liability, antitrust, privacy, and other laws affecting biotechnology product commercialization. It may serve as lead counsel to product lifecycle and cross-functional teams; advise on business strategies, transactions, regulatory submissions, label negotiations, privacy and data use, and relationships with healthcare and other stakeholders; and develop and deliver compliance training. The role also works with co-promotion partners, advises senior leaders, helps create efficient client processes, and participates in or leads company committees and project teams.

The role is located at Roche’s Genentech campus in South San Francisco, California. It is not eligible for a fully remote working arrangement. Relocation benefits are unavailable. The stated California salary range is $181,800 to $337,600, with actual pay dependent on experience, qualifications, location, and other permitted factors. A discretionary annual bonus may be available based on individual and company performance. The position qualifies for benefits referenced in the posting.

Requirements

• Juris Doctor (JD) degree.
• Currently licensed to practice law in good standing in at least one U.S. state.
• Registered or currently eligible as Registered In-House Counsel in California.
• At least 5 years of experience in legal counseling for therapeutic area product support of biotechnology or pharmaceutical clients.
• Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws concerning fraud and abuse in the life sciences, biotechnology, or pharmaceutical industries.
• Excellent oral and written communication skills.
• Ability to collaborate as a team player in global, matrixed environments.
• Ability to influence without authority and present complex information to senior leaders.
• Adaptability to possible early-morning or late-evening calls to accommodate global time zones.
• Willingness to undertake necessary international travel for global support and alignment.

Responsibilities

• Provide legal advice, education, training, and direction on healthcare fraud and abuse laws, pricing, access, FDA labeling and promotional matters, cGMP compliance, product liability, antitrust, privacy, and other laws affecting commercialization of biotechnology products.
• Serve, as applicable, as lead legal counsel for product lifecycle and cross-functional product- or therapeutic-area-focused teams and initiatives.
• Advise on business strategies, tactical plans, implementation, business issues, legal assessments, and 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 relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, organized customers, and government entities.
• Develop and deliver training to internal clients, partners, and stakeholders on relevant compliance policies, procedures, practices, requirements, and enforcement trends.
• Liaise and negotiate with co-promotion partners’ legal counsel to support successful partnership outcomes.
• Identify opportunities to create value and manage legal issues; build strong relationships with client groups and Legal colleagues; develop effective processes; advise senior business leaders; and serve on business or leadership teams.
• Participate in, lead, or present to company committees and 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 detailed through a link in the posting; specific benefits are not listed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior