Boston, MA, 02133, USA
28 days ago
Associate Director, Product Counsel
Location: Boston, MA (Hybrid) Reporting to: VP, General Counsel & Chief of Staff Orchard Therapeutics, 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.
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