Overview

The Director, Healthcare and Commercial Counsel will be joining a dynamic, entrepreneurial organization with a top notch, client-focused legal department. The Healthcare and Commercial Counsel will work closely with Commercial, Medical Affairs, Patient Advocacy and Regulatory Affairs colleagues and across multiple other internal functional groups and cross-functional teams. 

 About the Role:

Duties will include:

 

  • Providing legal support to all functions within bluebird regarding the future commercialization of bluebird’s product candidates in the US:
    • Provide legal advice to the Commercial, Medical Affairs, Patient Advocacy and Regulatory organizations on daily activities
    • Provide risk management, mitigation counseling and brand planning advice
    • Serve as Legal representative on relevant review committees to review and approve promotional materials, disease awareness, social media initiatives and scientific presentations, etc.
    • Participate in field team training, patient services development, speaker programs and product labeling
    • Guide interdisciplinary teams on health care compliance
  • Advise on applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, healthcare organizations, payers, patients, advocacy groups and other business partners, including, but not limited to compliance with Federal and state anti-kickback statutes, False Claims Act, the Food, Drug and Cosmetic Act, HIPAA and product liability law
  • Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the bluebird organization

 About You:

  • J.D. degree or equivalent from a national law school and admitted to practice in the United States
  • 7+ years of experience in healthcare compliance law; leading law firm and/or in-house biotechnology/pharmaceutical experience is necessary
  • Understanding of, and experience with, regulatory framework applicable to interactions with healthcare professionals, healthcare organizations, payers, advocacy and other business partners
  • Strong understanding of biotech or pharmaceutical operations and the ability to create policies and programs that work for the business
  • Strong problem-solving and organizational skills and program and process management experience
  • Proven track record of delivering independently and consistently on complex projects under challenging circumstances
  • Ability to communicate effectively both verbally and in writing in both individual and group settings
  • Strong commitment to healthcare compliance and business ethics
  • Willingness to grow and change as bluebird continues to grow and change
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

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