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Counsel - Legal Healthcare/Regulatory

Company: AbbVie
Location: Sunnyvale
Posted on: December 4, 2019

Job Description:

General Position Summary/Purpose: Counsel - Legal Healthcare/Regulatory is responsible for providing legal, regulatory and healthcare compliance counsel and handling a variety of business transactions, and commercial contracting. Serve as Counsel for IMBRUVICA and frequently interact with and provide substantive advice to cross-functional departments including Commercial, Medical Affairs, and Regulatory Affairs. Provide counsel concerning a broad range of legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals.Key Accountabilities/Core Job Responsibilities:

  • Provide legal advice and assistance for the development of policies, training and conduct training.
  • Responsible for compliance with applicable Corporate Policies and procedures.
  • Work cross functionally with various departments to meet business objectives.
  • Responsible for preparing, reviewing and negotiating commercial agreements, 3rd party vendor agreements, service agreements, pharmacy agreements, consulting agreements and other corporate agreements.
  • Develop knowledge of Pharmacyclics' business and supported client areas.
  • Represent Pharmacyclics externally to customers, suppliers, competitors or government agencies.
  • Resolve legal issues using negotiation skills and legal expertise.
  • Help select and direct the work of outside counsel, define project objectives and manage project
  • Assist Pharmacyclics Head of Legal on matters of significant importance.
  • Serve as recognized source, for the business as well as other attorneys, regarding innovative ideas in complex areas of law, business, or technology.
  • Be committed to meeting patient unmet needs and be energized by rising to new challenges and coming up with creative solutions to serve patients.
  • Be energized by challenging and interesting legal work and novel business problems.
  • Stay abreast of changes in laws that affect client areas.
  • Clearly define project objectives with capable management
  • Identify unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company and manage risk.
  • Have excellent communication skills.
  • Ability to prioritize and manage multiple projects.
    • Minimum 4+ years of relevant experience.
    • JD required.
    • Must meet the professional licensing requirement of the state in which they practice.
    • Experience with pharmaceutical/biotech companies required, and educational background in applicable scientific field is a plus.
    • Experience with Market Access/Managed Health Care matters is desirable, but not required.

Keywords: AbbVie, Sunnyvale , Counsel - Legal Healthcare/Regulatory, Healthcare , Sunnyvale, California

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