Our client, a private, rapidly growing global biopharmaceutical company, is seeking to add an experienced healthcare attorney to its legal team. Under the direction of the Global Chief Legal Officer, the Associate General Counsel, Healthcare Law will provide a broad range of legal services and guidance, primarily providing advice and support to the commercial and medical affairs organization. The Associate General Counsel will be a partner to the organization providing seasoned advice on a variety of matters related to all stages of drug development, including regulatory issues, advertising and promotion, privacy, healthcare fraud and abuse, and general legal liability. This position requires a self-motivated attorney who consistently demonstrates excellent judgment and ethics when delivering solutions-oriented, proactive, and strategic legal advice.
Responsibilities will include:
- Providing seasoned, risk-based advice on a variety of matters related to all stages of drug development, including, regulatory issues, advertising and promotion, healthcare fraud and abuse, and general legal liability.
- Providing advice, education, and legal direction on, healthcare fraud and abuse laws, contracting and pricing, FDA labeling and promotional matters, patient support programs, managed markets, government pricing, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products.
- Counseling on appropriate relationships with healthcare professionals, clinics and societies, patients and advocacy organizations, and government entities.
- Serving as the brand attorney in support of key customer-focused groups; regularly interacts with team members in the commercial, medical affairs, and policy and payer departments.
- Participating in the multidisciplinary committee reviewing promotional, marketing and advertising materials.
- Participating in the multidisciplinary committee reviewing medical affairs materials.
- Collaborating with the compliance department to assure that appropriate policies and training programs for employees are implemented to support and sustain the company’s strong commitment to compliance with governing laws and regulations.
- Providing advice on and assistance in negotiating and documenting commercial relationships, compliance and business matters over a broad range of business relationships including vendors, collaborators, clinicians and business partners.
- Proactively identifying and seizing opportunity 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, acting as a standing or ad hoc member of business or leadership teams.
The ideal candidate will have:
- 12+ years of recent relevant experience counseling on matters related to the sales, marketing, and commercialization of bio/pharmaceutical products (preference of at least 10 years experience serving as in house counsel).
- JD degree with admission to the California Bar or Registered in House Counsel.
- Excellent current understanding of the U.S. Food, Drug and Cosmetic Act and related regulations, and U.S. healthcare fraud and abuse laws, including the federal False Claims Act and the Anti-Kickback Statute, as well as up-to-date familiarity with guidance and enforcement priorities of government enforcement and regulatory agencies.
- Substantial previous experience applying U.S. Healthcare laws in the context of real-world bio/pharmaceutical business scenarios, and expertise in developing and implementing innovative solutions for complex legal matters.
- Excellent oral and written communications skills.
- Demonstrated leadership and organizational savvy necessary to lead and collaborate effectively with cross-functional client teams.
- Strong ability to influence and present complex information to senior leaders and tackle challenging issues beyond the practice area.
- Proven ability to assess, calibrate, and effectively communicate legal risk.
- Demonstrated success in proactively and independently driving for and delivering results with high impact.
- Ability to thrive in a fast-paced, quickly evolving and growing environment and enjoy working on a variety of items each day.
- Ability to operate independently with autonomy and limited supervision.
The company offers comprehensive medical benefits, generous vacation/holiday time off, competitive 401(k) matching, a super cool team and a Bay Area office with great views within walking distance of Caltrain.
The company offers an attractive compensation package that includes a competitive base salary (estimated range of $224,000-285,000/year), incentive bonus and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location and other job-related factors permitted by law.
The company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Solutus has been selected as the exclusive representative for this search. Interested candidates may contact us at firstname.lastname@example.org for consideration. Candidates applying directly to our client will be redirected to Solutus for consideration.