**General Description:** We are seeking an experienced biotechnology/pharmaceutical law attorney to provide legal support, counseling, and strategic guidance on commercial and regulatory matters for in North America. This role will be the lead product counsel to support one of our products. The successful candidate will have 8+ years of commercial and regulatory legal experience representing biotechnology/pharmaceutical companies in the United States across the entire product lifecycle, from clinical development, to regulatory approval and product launch, to post-marketing activities. This position will be located in the United States, either remote or at one of our offices in San Carlos, CA, Cambridge, MA, or Hopewell, NJ. **Essential Functions of the job:** + Provide timely and practical advice and guidance on healthcare laws and regulations applicable to product development and commercialization in North America. + Acting independently, serve as the legal representative on various cross-functional teams, including promotional and medical review committees, product development teams, medical affairs and marketing teams, and senior leadership. + Provide advice with respect to access and reimbursement, payer communications, and patient support programs. + Provide proactive and strategic guidance on healthcare regulatory matters across business functions, including commercial messaging, clinical development, medical affairs communications, regulatory, and healthcare compliance. + Review and provide guidance on a wide range of promotional and non-promotional materials, including branded promotional materials, disease education/disease awareness campaigns, scientific communications, speaker programs, patient education materials, grants and sponsorships, sales training, and reprint and publications plans. + Counsel on appropriate relationships with healthcare professionals, patients, managed care entities, advocacy organizations, and government entities, consistent with relevant healthcare laws, guidance documents, and current enforcement trends. + Review and advise on healthcare regulatory matters related to external communications, such as scientific journal articles, abstracts, presentations at medical conferences, press releases, and investor presentations, and participate in internal and external working groups such as trade associations and government affairs activities. + Review and negotiate commercial agreements, including marketing, distribution and other related agreements. + Assist with the development and implementation of policies and procedures related to healthcare compliance, including interactions with healthcare professionals, speaker programs, patient access and reimbursement support, expanded access, advisory boards, market access, and activities at scientific congresses. **Supervisory Responsibilities:** N/A **Other Qualifications:** + 8+ years of experience in a healthcare law role in the biotechnology/pharmaceutical industry, with significant experience supporting branded biotech/pharmaceutical product(s), including participation in promotional and medical review processes, preferably in oncology and for accelerated approval product(s). + Strong command of relevant healthcare laws, market access, regulations, guidance, industry codes, and enforcement trends. + Ability to manage and serve a wide range of client groups by recognizing and responding quickly and pragmatically to urgent situations and competing demands. + Exceptional and demonstrated written and verbal communication skills and interpersonal skills in both one-on-one and group settings. + Excellent organizational skills and problem-solving capabilities. + Ability to make risk-based judgements and provide clear and concise practical, solution-orientated guidance on complex matters. + Confidence and presence to advise clients at all levels with limited oversight. **Education Required:** Juris Doctorate **Travel:** Approximately 5-10% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.