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United Therapeutics Corporationposted 3 months ago
$230,000 - $285,000/Yr
Full-time - Senior
Remote - Atlanta, GA
Professional, Scientific, and Technical Services

About the position

The Senior Counsel, Regulatory & Compliance role at United Therapeutics is a key legal position responsible for overseeing a wide range of legal, regulatory, and compliance issues within the pharmaceutical and biotech sectors. This position provides expert legal support to various departments, ensuring adherence to healthcare laws and regulations throughout the commercial lifecycle of the company's products. The role involves collaboration with multiple teams, managing outside counsel, and staying updated on regulatory changes to guide the company effectively.

Responsibilities

  • Provide guidance to Sales, Marketing, Medical Affairs, Patient Relations, Regulatory and Corporate Compliance departments related to healthcare laws and regulations.
  • Serve as Legal representative on the Company's promotional review committee, including review of promotional and sales training materials.
  • Support the build out of the Company's Patient Relations function, including providing advice related to reimbursement support and patient support programs.
  • Review Needs Assessment Forms related to HCP consulting activities and associated materials.
  • Serve as the Legal representative on the Company's medical communications review, including review of MSL materials and health economic related materials.
  • Assist with the review, drafting and/or revising of compliance related policies and standard operating procedures, as well as corresponding training materials.
  • Assist with privileged compliance audits and investigations, including the development of any corresponding corrective action plans.
  • Participate in and provide guidance to the Company's Compliance Committee.
  • Assist the Compliance Department with annual Risk Assessment and Mitigation process, including providing guidance on levels of risk and corresponding risk mitigation activities.
  • Stay abreast of changing regulatory and enforcement landscape and keep business leaders informed of the same.
  • Manage outside counsel on compliance and regulatory matters.
  • Provide backup legal support for general corporate legal issues as required.
  • Perform all other related duties as assigned.

Requirements

  • Juris Doctorate (JD) from an accredited law school
  • 10+ years of experience as an attorney
  • 8+ years of experience in healthcare and FDA law
  • 4+ years of experience as in-house counsel at a pharmaceutical or biotech company
  • Solid command of relevant legal subject matter with the ability to manage collateral areas of legal responsibility
  • Effective communicator and collaborative team member
  • Strong written communication and drafting skills
  • Mac/PC and MS Office proficient
  • Ability to work in a fast-paced, dynamic environment
  • Candidates preferred location in EST
  • Must be able to travel to RTP, NC at a minimum of one week per month

Nice-to-haves

  • Experience with Veeva PromoMats

Benefits

  • Medical, dental, and vision coverage
  • Prescription coverage
  • Employee wellness resources
  • Savings plans (401k and ESPP)
  • Paid time off
  • Paid parental leave benefits
  • Disability benefits
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