Legal Counsel, Therapeutic Area Product Support

Genentech; San Francisco (CA); Sur place; USD 182 000 - 338 000; Plein temps

Résumé du poste

Genentech, located at the South San Francisco campus, seeks a Legal Counsel for Therapeutic Area Product Support to provide US and global legal advice across the lifecycle of biotech products, including regulatory submissions, product strategy, and commercial support. You will work with commercial, medical affairs, market access and government affairs teams on regulatory, privacy, and compliance issues.

The role requires a JD and bar admission with at least 5 years of biotech/pharma experience,

Qualifications

• JD degree and active U.S. bar license in good standing.
• Licensed to practice in at least one U.S. state and eligible as Registered In-House Counsel in California.
• 5+ years of legal counseling experience in biotech/pharma therapeutic area products.
• Strong knowledge of enforcement trends, FDA/FDCA and False Claims Act.

Responsabilités

• Provide legal advice on healthcare fraud and abuse laws, pricing, FDA labeling, and promotional matters.
• Lead as lead or co-lead legal counsel for product lifecycle and cross-functional therapeutic area teams.
• Advise on business strategies, risk mitigation, and development of legal assessments.
• Advise on transactions to support external collaborations and partnerships.
• Advise regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy/data use.
• Counsel on relationships with healthcare professionals, clinics, societies, patients and advocacy groups.
• Develop and implement training on key policies, procedures and compliance trends for internal clients and partners.
• Liaise with co-promotion partners’ counsel to enable successful partnership outcomes.
• Participate in and present to company committees or leadership teams.

Connaissances

Healthcare law

FDA regulations

Enforcement trends

Legal counseling

Formation

JD / Doctor of Law

Description du poste

The Position

Genentech is hiring a Legal Counsel for Therapeutic Area Product Support, based on the Genentech campus, a member of the Roche Global Legal Pharma group. As a key partner and business strategist, this position will provide US and global legal advice and support across the lifecycle of Roche/Genentech’s growing portfolio of innovative medicines, including commercial, medical affairs, market access, and government affairs. Supported business teams include global product strategy teams, product sales and marketing, commercial strategic and operational functions, regulatory, market access (patient access, pricing, contracting and distribution), U.S. medical affairs, and certain global teams.

THE OPPORTUNITY

Key Responsibilities:

Key responsibilities of this individual contributor role includes the following:

• 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; and

• Participating in, leading and/or presenting to various Company committees or other advisory, project or work teams.

WHO YOU ARE

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.

The expected salary range for this position based on the primary location of California is$181,800 to $337,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.