Legal Counsel, Therapeutic Area Product Support

Roche • South San Francisco, CA

1d • $181,800 - $337,600 • Onsite

About The Position

Genentech is hiring a Legal Counsel for Therapeutic Area Product Support, based at the Genentech campus in South San Francisco and part of the Roche Global Legal Pharma group. The role provides U.S. and global legal advice and support across the lifecycle of Roche/Genentech’s portfolio of innovative medicines, partnering with commercial, medical affairs, market access, government affairs, regulatory, and other business teams. Supported clients include global product strategy teams, product sales and marketing, commercial strategic and operational functions, patient access, pricing, contracting and distribution, U.S. medical affairs, and certain global teams.

This individual-contributor role advises on legal and business matters affecting biotech product commercialization, supports product lifecycle and cross-functional initiatives, and develops practical legal assessments and risk-mitigation strategies. It also advises on collaborations, regulatory submissions, label negotiations, privacy and data use, and relationships with healthcare professionals, patients, advocacy organizations, customers, and government entities. The role develops and delivers compliance training, works with co-promotion partners’ counsel, supports business and Legal colleagues, advises senior leaders, and participates in or leads company committees and project teams.

The position is located onsite at Roche’s Genentech campus in South San Francisco, California. Fully remote work is not permitted. Relocation benefits are unavailable. The role may require early-morning or late-evening calls to accommodate global time zones and necessary international travel. The expected California salary range is $181,800 to $337,600. A discretionary annual bonus may be available based on individual and Company performance. The position qualifies for benefits detailed at a link in the posting.

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 work experience in legal counseling for therapeutic area product support of biotech 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, biotech, or pharmaceutical industries.
• Excellent oral and written communication skills.
• Teamwork and strong collaboration skills 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.

Responsibilities

• Provide legal advice, education, training, and direction on healthcare fraud and abuse laws, pricing, access, FDA labeling and promotional matters, cGMP compliance, products liability, antitrust, privacy, and other laws affecting biotech product commercialization.
• Serve as lead legal counsel for product lifecycle and cross-functional product- or therapeutic-area-focused teams and initiatives, as applicable.
• Advise on business strategies, tactical plan development and implementation, and other business issues; develop 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 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 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 and manage legal issues.
• Build strong relationships with client groups and Legal colleagues, create effective processes for working with clients, 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 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 at a link in the posting; specific benefits are not listed.

What This Job Offers

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