uniQure
Overview
Join to apply for the Senior Counsel, Commercial Law role at uniQure. At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. The Senior Counsel, Commercial Law will provide strategic legal advice to uniQure’s commercial, medical affairs, market access and patient support functions in support of uniQure’s planned first launch in the United States. Responsibilities
Partner with and provide pragmatic legal advice to rapidly growing Commercial and Medical Affairs organizations; identify and resolve critical legal and business issues related to product launch and market entry; communicate solutions clearly and concisely. Provide counsel on state and federal laws and regulations impacting commercial operations, including Anti-kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, and state drug pricing transparency laws. Advise on distribution, trade, and channel strategy across specialty pharmacies, distributors, wholesalers, GPOs, and PBMs; support compliant patient programs; advise on coverage and reimbursement strategies under Medicare Parts B and D, Medicaid, and Veterans Health Act; address government pricing matters such as MDRPs and pricing reporting calculations; advise on FARs and the Veterans Health Act compliance in FSS contracts. Advise on promotional, medical, training and disease awareness materials for compliance with applicable laws by participating as Legal reviewer on promotional and medical materials review committees. Assist with government price reporting audits and related processes. Draft, review, and negotiate business agreements with vendors, healthcare professionals, centers of excellence, specialty pharmacies, patient support vendors, payor agreements, distributor, GPO and wholesaler agreements, and sponsorship/grant/charitable contribution arrangements. Ensure all agreements comply with applicable healthcare laws, internal policies and government pricing requirements. Partner with the broader Legal and Compliance teams and with internal clients as a trusted strategic business partner. Develop and conduct policies and training on relevant topics and legal developments; contribute to building a culture of compliance. As a member of the Commercial Legal Team, contribute to the legal function by fostering engagement and sharing best practices, and by participating in initiatives to build departmental knowledge and competencies. Qualifications & Skills
J.D. from an accredited law school and member in good standing of the Massachusetts bar. A minimum of ten years of experience within the biotech, pharmaceutical, or life sciences industry with knowledge of U.S. product development, commercialization, and launch; experience with trade, distribution, and market access contracting is a plus. Thorough understanding of healthcare laws and regulations related to commercialization and launch of biopharmaceutical products in the U.S. and preferably ex-U.S. (False Claims Act, Anti-Kickback Statute, OIG guidelines and opinions, Sunshine Act, FCPA, fraud and abuse, pricing laws and implications, and launch strategies). Pragmatic, agile, and able to manage multiple tasks and timelines in a fast-paced environment with attention to quality and detail. Ability to cultivate strong stakeholder relationships and influence leadership and peers with tact and professionalism. Commitment to collaboration, professionalism and ethical conduct, including handling confidential information. Excellent verbal and written communication skills. This is a hybrid position. The company is located in Lexington, MA. Onsite in Lexington 3 days per week; some travel may be required to Amsterdam, The Netherlands, and Basel, Switzerland. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Join to apply for the Senior Counsel, Commercial Law role at uniQure. At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. The Senior Counsel, Commercial Law will provide strategic legal advice to uniQure’s commercial, medical affairs, market access and patient support functions in support of uniQure’s planned first launch in the United States. Responsibilities
Partner with and provide pragmatic legal advice to rapidly growing Commercial and Medical Affairs organizations; identify and resolve critical legal and business issues related to product launch and market entry; communicate solutions clearly and concisely. Provide counsel on state and federal laws and regulations impacting commercial operations, including Anti-kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, and state drug pricing transparency laws. Advise on distribution, trade, and channel strategy across specialty pharmacies, distributors, wholesalers, GPOs, and PBMs; support compliant patient programs; advise on coverage and reimbursement strategies under Medicare Parts B and D, Medicaid, and Veterans Health Act; address government pricing matters such as MDRPs and pricing reporting calculations; advise on FARs and the Veterans Health Act compliance in FSS contracts. Advise on promotional, medical, training and disease awareness materials for compliance with applicable laws by participating as Legal reviewer on promotional and medical materials review committees. Assist with government price reporting audits and related processes. Draft, review, and negotiate business agreements with vendors, healthcare professionals, centers of excellence, specialty pharmacies, patient support vendors, payor agreements, distributor, GPO and wholesaler agreements, and sponsorship/grant/charitable contribution arrangements. Ensure all agreements comply with applicable healthcare laws, internal policies and government pricing requirements. Partner with the broader Legal and Compliance teams and with internal clients as a trusted strategic business partner. Develop and conduct policies and training on relevant topics and legal developments; contribute to building a culture of compliance. As a member of the Commercial Legal Team, contribute to the legal function by fostering engagement and sharing best practices, and by participating in initiatives to build departmental knowledge and competencies. Qualifications & Skills
J.D. from an accredited law school and member in good standing of the Massachusetts bar. A minimum of ten years of experience within the biotech, pharmaceutical, or life sciences industry with knowledge of U.S. product development, commercialization, and launch; experience with trade, distribution, and market access contracting is a plus. Thorough understanding of healthcare laws and regulations related to commercialization and launch of biopharmaceutical products in the U.S. and preferably ex-U.S. (False Claims Act, Anti-Kickback Statute, OIG guidelines and opinions, Sunshine Act, FCPA, fraud and abuse, pricing laws and implications, and launch strategies). Pragmatic, agile, and able to manage multiple tasks and timelines in a fast-paced environment with attention to quality and detail. Ability to cultivate strong stakeholder relationships and influence leadership and peers with tact and professionalism. Commitment to collaboration, professionalism and ethical conduct, including handling confidential information. Excellent verbal and written communication skills. This is a hybrid position. The company is located in Lexington, MA. Onsite in Lexington 3 days per week; some travel may be required to Amsterdam, The Netherlands, and Basel, Switzerland. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr