Sr Corporate Counsel
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position
The Senior Corporate or Corporate Counsel will work as part of the Healthcare Law Group within Genentech's Legal department.
The position will initially focus on counseling Genentech’s commercial sales and marketing clients, with opportunities to advise medical affairs and development across the lifecycle of products. The position may require counseling medical affairs and development teams with human medicines and companion diagnostics in all phases of development.
JOB/POSITION SCOPE:
- Manage outside counsel on complex or more advanced matters or projects
- Responsible for one or more key client relationships typically at Director level or higher
- May be single point of contact or represent practice group or functional area on significant projects or committees
- Provide advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
- Assist in structuring tactics and related contracts in compliance with applicable law;
- Serve as lead legal counsel for global development programs and medical affairs initiatives
- Negotiate agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and
- Draft and interpret company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.
- Act as a subject matter expert on all matters relating to healthcare law and related business operations
- Act as a standing or ad hoc member of business or leadership teams and provides legal counsel and expertise into business decisions
- Develop an in-depth understanding of assigned departments and functions in terms of their, organizational structure, processes, business goals, strategies and challenges, etc.
- Provide legal advice in matters relating to healthcare law, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of products
- Provide input and legal advice on business strategy, tactical plan development and implementation, and other business issues; including legal assessments, solutions-oriented risk mitigation strategies, messaging, and interactions with healthcare professionals, patients and other external parties
- Participate in, lead and/or present to various Company committees or other advisory, project or work teams and provides healthcare and business law expertise and guidance
- Review business materials (clinical trials, brand plans, promotions, medical plans, publications, training documents, etc.) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics
- Provide transactional support to assigned internal clients. May include drafting, negotiating, and/or reviewing contracts, creating, updating and training on contract templates, negotiating language, developing associated legal/contractual documentation and/or policies & procedures, and counseling on contract disputes
- Interact and communicate with Roche affiliates and global partners, as appropriate, to apprise them of relevant Company policies, procedures, practices, important business issues, etc. and share best practices or coordinate legal support
PEOPLE MANAGEMENT:
- May manage administrative personnel
- Where applicable, lead recruitment, hiring and on-boarding for direct report positions
- Accountable for direct reports' work to ensure on-time, on-target and within-budget results
- Ensure direct report(s) are appropriately trained, developed and coached
- Responsible for performance management of direct report(s)
DEVELOP & MAINTAIN KNOWLEDGE
- Stay abreast of evolving healthcare and related legislation and regulations and the enforcement landscape. Advises the Company and colleagues of potential implications to current or future strategies and operations and assures ongoing compliance
- Develop and implements training to educate internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance
- Attend various internal client meetings to stay apprised of business developments relevant to role
CONTRIBUTE TO HLG & THE LEGAL DEPARTMENT
- Participate in various HLG and Legal department projects and initiatives
- Assist with on-boarding and training new staff members or other partners in HLG practices, processes, systems, databases, other tools and resources, standards, key stakeholders and the like
- Share information and knowledge through group presentations and individual discussions with peers and managers
- Volunteer for additional work, as needed, such as assignments identified by functional leads and coverage for vacations, leaves, etc.
- Identify areas for improvement in HLG and/or Legal department processes (e.g. efficiencies, best practices, etc.) and culture. Develop solutions and communicate these to HLG and/or Legal department
Who You Are
The ideal candidate will have a JD with Bar admission from a top tier law school and recent relevant legal experience (at least 7 years for Senior Corporate Counsel) at a law firm with a nationally recognized FDA / Life Sciences practice or in a pharmaceutical or biotechnology company’s law department, with a focus on counseling pharmaceutical and/or clinical clients on laws and regulations related to the development, promotion, and sale of human medicines and companion diagnostics.
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 pharmaceutical and biotech industries is essential, along with excellent oral and written communications skills. You will join a team that enjoys learning and reaching increasing levels of legal and business competency.
The Healthcare Law Group, as part of the Genentech Law Department, values ongoing professional development and collegiality in support of our vision to be essential partners to our clients, driving business excellence to improve patient lives. We seek and cultivate self-motivated individuals who share this vision and consistently demonstrate excellent judgment, ethics, collaboration, and interpersonal skills.
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
