Overview
This role involves providing expert legal advice and counseling on a wide range of strategic and tactical projects within a highly regulated environment. Reporting to the Assistant General Counsel, the position supports business partners across various departments including Market Access (Payer Strategy, Trade & Distribution, Government Pricing), Government Affairs & Public Policy, and pipeline development. The ideal candidate will have experience advising prescription drug companies on legal issues related to market access, government pricing, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency, and patient assistance.
Responsibilities
- Advise business partners on commercial initiatives to advance organizational strategy while managing legal risks and protecting integrity and reputation.
- Provide legal counsel on:
- Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act.
- Market access and reimbursement issues.
- Government pricing, including price reporting compliance policies and reasonable assumptions documentation.
- Centers for Medicare and Medicaid final rules, correspondence, letters, and public comments on proposed rules and guidance.
- Federal and state legislation affecting pharmaceutical market access, pricing, reimbursement, drug price reporting, and transparency laws.
- Services and contracting related to specialty distributors and specialty pharmacies.
- Data and special projects.
- Brand strategic planning and business operation plans.
- Stay current on evolving healthcare legislation, regulations, and enforcement landscape.
- Ensure compliance with applicable laws and company policies, including the Anti-kickback Statute and other U.S. healthcare compliance laws.
- Collaborate with legal colleagues supporting commercial, pipeline, and privacy to deliver comprehensive legal advice.
- Review select materials for the Communication Review Committee.
- Participate in Legal & Compliance Department projects and initiatives, including committees such as Culture and Pro Bono & Community Engagement.
- Share knowledge through presentations and discussions with peers and managers.
Requirements
- Juris Doctor (JD) degree from an ABA-accredited law school.
- Membership in a state bar.
- Minimum of 8 years post-JD experience advising on legal matters in the life sciences sector, either in law firms or in-house within the biopharmaceutical industry.
- Experience with government price reporting.
- Expertise advising on statutes, regulations, and guidance applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance and advisory opinions, the False Claims Act, and the PhRMA Code.
- Strong verbal and written communication skills to effectively convey legal advice to lawyers and non-lawyers.
- Advanced contracting and redlining skills with strong attention to detail.
- Excellent analytical, problem-solving, and organizational skills to manage multiple responsibilities while meeting quality and timeliness standards.
- Ability to manage outside counsel effectively and adhere to budget constraints.
- Experience providing legal advice on specialty medicines is highly desirable.
Personal Attributes
- Self-starter and lifelong learner with a strong work ethic and excellent interpersonal skills.
- Enjoys working collaboratively and cross-functionally as well as independently.
- Proactively solves problems and makes decisions with integrity and ethics.
- Thrives in a fast-paced and dynamic environment.
- Eager to take on new challenges.
Compensation & Benefits
- Salary range: $214,400 - $321,600 (base salary).
- Eligible for annual bonus and equity awards.
- Some roles may be eligible for overtime pay in accordance with federal and state requirements.
- Total rewards include medical, dental, and vision benefits; generous paid time off including company shutdowns in summer and winter; educational assistance programs including student loan repayment; commuting subsidies; matching charitable donations; 401(k) plan; and more.
Location & Work Flexibility
- Remote-eligible position.
- Flex options include:
- Remote: work remotely five days per week with occasional office visits.
- Hybrid: work remotely up to two days per week.
- On-site: work five days per week on-site with ad hoc flexibility.
- Flex status is subject to organizational policies and may change.
Equal Opportunity & Accommodation
The organization is committed to equal employment opportunity and non-discrimination for all employees and applicants regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other protected characteristic under applicable law. Reasonable accommodations are provided for qualified individuals with disabilities during the hiring process and to perform essential job functions upon request.