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Vertex Pharmaceuticals

Develops therapies for serious genetic diseases

Director Commercial Legal Senior Counsel - Genetic Kidney

Legal Counsel & Legal SupportConfirmed live in the last 24 hours
Full-timeBoston, MA, USA

About the Job

Requirements

  • Experience supporting pre- and post-launch biopharmaceutical products.
  • Demonstrated experience advising on healthcare regulatory and compliance matters, including advertising and promotion, healthcare fraud and abuse, patient support, scientific exchange, and interactions with healthcare stakeholders.
  • Demonstrated ability to interpret and apply the Food, Drug, and Cosmetic Act, anti-kickback statutes, the False Claims Act, the Lanham Act, and related regulations and guidance.
  • Experience advising communication review committees and providing guidance on FDA's CFL, payor, and SIUU guidance.
  • Strong communication skills, including the ability to convey complex legal concepts to diverse audiences and influence key stakeholders.
  • Strong analytical and problem-solving skills, including the ability to apply sound judgment and develop practical legal solutions.
  • Juris Doctor degree from an ABA-accredited law school.
  • Active membership in good standing with a state bar.
  • At least 7 years of post-Juris Doctor experience in healthcare law within a biopharmaceutical company, law firm, or combination of both.
  • Ability to build effective working relationships and apply sound business judgment and ethical decision-making with a proactive, solutions-oriented approach.
  • Ability to work effectively in a fast-paced, dynamic environment while managing multiple priorities.
  • Ability to collaborate effectively with colleagues and value diversity and inclusion as drivers of team success.

Responsibilities

  • Serve as a trusted legal advisor to the U.S. and global Genetic Kidney commercialization teams, providing strategic counsel on commercialization initiatives and business priorities.
  • Provide practical, business-focused legal advice on advertising and promotion, scientific exchange, healthcare fraud and abuse, patient support, and other matters related to the commercialization of prescription drugs.
  • Advise stakeholders on the interpretation and application of healthcare laws, regulations, agency guidance, and enforcement trends.
  • Identify emerging legal risks and opportunities and recommend proactive, workable solutions that support compliant business execution.
  • Translate complex legal and regulatory considerations into clear guidance for a range of business audiences.
  • Partner with U.S. Sales and Marketing, Global Commercial Strategy, Medical Affairs, Field Training, Regulatory Advertising and Promotion, Public Affairs, Patient Advocacy, and Corporate Communications.
  • Participate actively in communication, medical, and label review committees to ensure compliance and alignment with business goals.
  • Build productive working relationships with internal stakeholders to align legal strategies with business priorities.
  • Contribute to department-wide initiatives, including culture-building and pro bono programs.
  • Provide counsel on healthcare laws, including the Food, Drug, and Cosmetic Act and associated regulations, anti-kickback statutes, the False Claims Act, and the Lanham Act.
  • Support compliant interactions with patients, caregivers, healthcare professionals, and other healthcare stakeholders.
  • Apply sound judgment to identify, assess, and mitigate legal and reputational risks.
  • Help safeguard Vertex's integrity while enabling the business to meet commercialization objectives.

About the Company

Vertex Pharmaceuticals

Develops therapies for serious genetic diseases

Vertex Pharmaceuticals develops medicines for serious diseases, with a focus on cystic fibrosis. It conducts extensive research and partners with other biotech firms to discover and develop new therapies, including ex vivo engineered cell treatments. Its products, such as ivacaftor, treat cystic fibrosis and other therapies undergo clinical testing to expand the pipeline. Revenue comes from selling approved drugs and from licensing and collaboration agreements. The company distinguishes itself through deep R&D investment, strategic partnerships, and a global reach aimed at addressing unmet medical needs. The overall goal is to bring effective new drugs to patients worldwide and improve outcomes and quality of life.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1989

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