Description:

A Biopharmaceutical Company, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, is looking for a lawyer to provide commercial and compliance legal support. The ideal candidate will have a strong understanding of relevant healthcare laws relating to the sale and promotion of gene therapy products in the United States.

Summary of Key Responsibilities:

Provide legal support on a broad range of commercial topics and ensure the business is complying with all relevant healthcare laws and company policies.
Negotiate commercial agreements, including contracts with hospitals, government entities, payors and others.
Provide legal review of materials, including promotional and non-promotional pieces.
Advise business colleagues on interactions with key stakeholders, including patients, physicians, payors and others.
Educate colleagues by providing training and periodic updates on relevant legal developments.
Work directly with relevant business colleagues, and provide pragmatic, solutions-oriented, proactive counseling.

Requirements:
Qualifications, Experience and Skills

JD from an ABA accredited law school and member of a state bar.
Minimum of 3-years post-JD experience advising on legal matters in the life sciences space, whether in a law firm or in-house in the biotech or biopharmaceutical industry, or both. Experience with gene therapy companies preferred.
Experience advising on statutes, regulations and guidance documents applicable to promotion of therapeutics, including federal and state anti-kickback statutes, OIG guidance documents and advisory opinions, the False Claims Act and the PhRMA Code. Up-to-date knowledge of applicable laws, regulations and best practices in the field.
Ability to effectively manage outside counsel and adhere to a budget.
Effective at communicating complex information to stakeholders in an accessible way.
High integrity and ability to treat confidential information with great discretion.
Exceptional oral and written communication skills, including drafting skills and presentation abilities and strong interpersonal skills.
History of working independently on projects, meeting deadlines and juggling multiple matters through strong organizational and prioritization skills.