Counsel - Legal Healthcare/Regulatory
Posted on: December 4, 2019
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
- Provide legal advice and assistance for the development of
policies, training and conduct training.
- Responsible for compliance with applicable Corporate Policies
- Work cross functionally with various departments to meet
- Responsible for preparing, reviewing and negotiating commercial
agreements, 3rd party vendor agreements, service agreements,
pharmacy agreements, consulting agreements and other corporate
- Develop knowledge of Pharmacyclics' business and supported
- Represent Pharmacyclics externally to customers, suppliers,
competitors or government agencies.
- Resolve legal issues using negotiation skills and legal
- Help select and direct the work of outside counsel, define
project objectives and manage project
- Assist Pharmacyclics Head of Legal on matters of significant
- 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
- 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
- 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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