Legal Counsel, Therapeutic Area Product Support

Key Responsibilities

• Providing 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 impacting the commercialization of biotech products
• May serve 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 on transactions to support external collaborations and partnerships
• Advising 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, organized customers, 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
• Liaising and negotiating with co-promotion partners' legal counsel to enable and drive for successful partnership outcomes
• Identifying opportunities to create value to the business and Legal colleagues and manage legal issues, fostering strong relationships with client groups and Legal colleagues, creating efficient and effective processes for working with clients, advising senior business leaders, and acting as a standing or ad hoc member of business or leadership teams
• Participating in, leading and/or presenting to various Company committees or other advisory, project or work teams

Required Education, Experience and Competencies

• Education & Legal Bar License: Must have an advanced law degree (i.e. JD) and must be currently licensed to practice law, in good standing, in at least one U.S. state, and must be registered or currently eligible as a Registered In-House Counsel in California.
• Experience: 5+ years of work experience in the legal counseling of therapeutic area product support of biotech/pharma clients.
• Subject Matter Expertise: 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 science/biotech/pharma industries.
• General Competencies: Excellent and effective oral and written communications skills. Team player and strong collaboration skills for global, matrixed environments. Ability to influence without authority and present complex information to senior leaders.
• Global Operating Model and Travel: Requires adaptability for possible early morning/late evening calls to accommodate global time zones and a willingness to undertake necessary international travel to ensure effective global support and alignment.

Location

• This role is located at Roche's Genentech campus in South San Francisco, California.
• Relocation benefits are not available for this position.
• This role is not allowable for a fully remote working arrangement.