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The US Commercial & Regulatory Counsel will be a key member of the global legal, compliance and IP team and is responsible for providing legal, regulatory, and strategic advice in support of the development, launch and commercialization of argenx’s in-line products. The Counsel will work closely with the US Commercial and Medical teams and with other members of the global legal and compliance team both in the US and abroad.  The Counsel will advise on a broad range of legal and regulatory issues, including application and interpretation of FDA regulations and guidance, the False Claims Act, Anti-Kickback Statute, HIPAA / privacy law, competition law and other relevant laws and regulations governing the commercialization of biopharmaceutical products, product labeling, promotional and educational activities, marketing strategies, interactions with healthcare professionals, grants, sponsorships, and patient support programs.  This role will be at the Associate Director or Director level based on experience.

In addition to these core responsibilities, the Counsel will have significant opportunity to expand his or her expertise within a rapidly growing legal department in a global biotech company.

Roles and Responsibilities:

• Provide strategic, operational, and risk-based legal and business guidance for the company’s development, launch, and commercialization activities in the US supporting VYVGART IV and VYVGART SubCu for hematology and dermatology indications.
• Advise clients on the Food, Drug & Cosmetic Act, FDA regulations, the Anti-Kickback Statue, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, speaker bureaus, grants, sponsorships and other programs, communications with FDA, non-promotional materials developed to support scientific exchange and health economics materials.
• Serve as a member of argenx Materials Review Committees, along with medical and regulatory colleagues.
• Provide strategic guidance on interactions with patients, healthcare professionals, institutions, and regulatory agencies.
• Serve as a subject matter expert in the areas of healthcare law and applicable pharmaceutical marketing, anti-kickback, privacy, fraud and abuse, anti-bribery, and product liability statutes and regulations.
• Work with the business to draft, review and negotiate contracts relating to marketing services, consulting and advisory boards, third party vendors, and service agreements.
• Partner with Compliance to review, revise, and provide training on relevant laws, regulatory issues, and argenx policies.
• Additional duties and responsibilities as required.

Education, Experience and Qualifications: 

• J.D. degree from an ABA-accredited law school.
• Admitted to practice law in good standing in Massachusetts or another U.S. jurisdiction.
• A minimum of 5 years of relevant legal experience in the biopharmaceutical industry and/or a law firm.
• Knowledge and expertise with commercial healthcare laws and regulations applicable to global pharmaceutical companies, including FDA regulatory law and regulation on labeling and promotional matters, healthcare fraud and abuse and anti-bribery laws including the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, US transparency laws and regulations, the PhRMA Code on Interactions with Healthcare Professionals, privacy laws, and other laws and regulations related to the development and commercialization of biopharmaceutical products.
• The ideal candidate will have worked at a leading U.S. national law firm and/or had an in-house counsel position with a leading biotech/pharmaceutical company with marketed products.
• J.D. degree from an ABA-accredited law school.
• Admitted to practice law in good standing in Massachusetts or another U.S. jurisdiction.
• A minimum of 5 years of relevant legal experience in the biopharmaceutical industry and/or a law firm.
• Knowledge and expertise with commercial healthcare laws and regulations applicable to global pharmaceutical companies, including FDA regulatory law and regulation on labeling and promotional matters, healthcare fraud and abuse and anti-bribery laws including the Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, US transparency laws and regulations, the PhRMA Code on Interactions with Healthcare Professionals, privacy laws, and other laws and regulations related to the development and commercialization of biopharmaceutical products.
• The ideal candidate will have worked at a leading U.S. national law firm and/or had an in-house counsel position with a leading biotech/pharmaceutical company with marketed products.

Skill and Competencies:

• Strong interpersonal and oral and written communication skills; communicates in an open, clear, complete, timely and consistent manner.
• Able to innovate, analyze and solve problems with supervisory input, anticipating and identifying legal and other business risks and making recommendations to management, as appropriate.
• Solid understanding of business goals and legal and regulatory landscape.
• Demonstrated ability to develop and cultivate collaborative relationships with stakeholders to effectively communicate challenges and opportunities and deliver solutions, as needed.
• High degree of personal, professional, and corporate ethics, integrity, and responsibility.
• Agility, flexibility, and openness to change in a growing, multi-cultural environment.
• Able to work well with others and communicate with cross-functional colleagues and senior leadership; able to establish a working relationship of trust and rapport with colleagues at all levels, both office-based and field-based and across all argenx locations.
• Capable of strategic thinking and proposing innovative solutions to legal-related challenges.
• A collaborator, who listens effectively and invites response and discussion.
• Excellent negotiation skills requiring effective interpersonal communication and oral and written communication skills.
• Ability to independently manage workload in a fast-paced, purposeful, highly accountable environment.