Legal Senior Counsel, Market Access

Job Summary 

The person in this role will provide expert advice and counseling to the business on a broad array of strategic and tactical projects within a highly regulated environment.  This position will report to the Assistant General Counsel and will be responsible for providing legal support to business partners in various departments across the organization, such as Market Access which includes Payer Strategy, Trade & Distribution and Government Pricing, Government Affairs & Public Policy, and pipeline.  The ideal candidate will have prior experience counseling prescription drug companies on legal issues relating to market access, government pricing, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency and patient assistance. 

Key Responsibilities 

Provide Advice and Counsel to Business Partners 

• Advise business partners on various Commercial initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputation 

• Provide legal advice and 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 documents  

• Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance 

• Proposed and enacted United States federal and state legislation impacting pharmaceutical companies relating to market access, pricing, reimbursement as well as state drug price reporting and transparency laws and compliance 

• Services and contracting relating to specialty distributors and specialty pharmacies 

• Data and special projects  

• Brand strategic planning and business operation plans 

• Staying abreast of evolving healthcare legislation and regulations and the enforcement landscape  

• Ensure compliance with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations 

• Collaborate with legal colleagues supporting commercial, pipeline and privacy to ensure delivery of comprehensive legal advice 

• Review select materials in Communication Review Committee 

Contribute to the Legal & Compliance Department 

• Participate in various Legal & Compliance Department projects and initiatives, including committees such as Culture and Pro Bono & Community Engagement 

• Share information and knowledge through group presentations and individual discussions with peers and managers  

Qualifications, Professional Skills, and Preferred Experience 

• JD from an ABA accredited law school  

• Member of a state bar  

• Minimum of 8 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or both 

• Government price reporting experience 

• Experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA Code 

• Outstanding ability to effectively communicate (verbally and in writing), sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needs  

• Advanced contracting and redlining skills with strong attention to detail 

• Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards 

• Ability to effectively and efficiently manage outside counsel and adhere to a budget 

• Experience providing legal advice on specialty medicines is highly desired 

Personal Attributes 

Self-starter and life-long learner with a strong work ethic and excellent interpersonal skills who  

• Enjoys working collaboratively and cross-functionally on teams, as well as independently 

• Proactively solves problems and makes decisions with integrity and ethics 

• Thrives in a fast-paced and dynamic environment 

• Is eager to take on new challenges