The Senior Counsel, Commercial Legal position provides legal, regulatory and healthcare compliance counsel for our Immunology business unit as well as our Patient Services organization. This position advises cross-functional departments including Commercial, Medical Affairs and Regulatory Affairs. This includes counseling on a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, government reimbursement, patient support, and interactions with healthcare professionals.
- Work cross functionally with various departments to meet business objectives.
- Provide clear advice to business clients and senior legal management on U.S. laws focusing on areas of promotion, patient support, payor access, go-to-market strategies, and scientific exchange.
- Provide legal advice and assistance for the development of policies and training, and conduct training.
- Develop knowledge of the Immunology disease state and proactively guide commercial, medical and regulatory clients related to same.
- Help select and direct the work of outside counsel, define project objectives, and manage budget.
- Serve as recognized source, for the business as well as other attorneys, regarding innovative ideas in complex areas of law, business, or technology.
- Be committed to meeting patient unmet needs and be energized by rising to new challenges and coming up with creative solutions to serve patients. Be energized by challenging and interesting legal work and novel business problems.
- Stay abreast of changes in laws that affect client areas.
- Identify unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company and manage risk.
- JD required.
- Minimum 8+ years of relevant experience with pharma/health care matters.
- Experience with market access/managed health care matters (desirable, but not required).
- Possess excellent communication skills.
- Have the ability to prioritize and manage multiple projects.
Significant Work Activities: N/A
Travel: Yes, 5 % of the Time
Job Type: Experienced