● Providing advice, education, training and legal direction on, healthcare fraud and abuse laws, pricing, FDA labeling and promotional matters, cGMP compliance, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
● Serving 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; and
● Liaising and negotiating with co-promotion partners’ legal counsel to enable and drive for successful partnership outcomes.
● Proactively identifying and seizing opportunities to create value and manage legal issues, fostering strong relationships with client groups, creating efficient and effective processes for working with clients, advising senior leaders in the commercial and medical affairs organizations, 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
● Licensed to practice law in one or more jurisdictions.
● 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 industries.
● Excellent oral and written communications skills.
● Demonstrated leadership on cross-functional teams.
● Team player and strong collaboration skills.
● Strong ability to influence and present complex information to senior leaders.
● Demonstrated success in proactively and independently driving for and delivering results with high impact.
● Demonstrated enterprise and growth mindset.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 and ethics while delivering solutions-oriented, proactive, and strategic legal advice.