Counsel - Legal Healthcare/Regulatory
Company: Pharmacyclics, LLC
Posted on: September 12, 2019
Pharmacyclics is committed to the development and commercialization
of novel therapies intended to improve the quality and duration of
life and to resolve serious unmet medical needs for cancer
patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie
(NYSE:ABBV), a global, research-based biopharmaceutical company.
Oncology is a key therapeutic area for AbbVie, with a portfolio
consisting of three marketed products and a pipeline containing
multiple promising new molecules that are being studied in more
than 200 clinical trials for over 20 different types of cancer.
More than 1,200 Pharmacyclics and AbbVie research scientists,
clinicians, marketing, operations and corporate professionals work
in the San Francisco Bay Area. They combine their expertise in
immuno-oncology, stem cells, and cell-signaling with their
knowledge of bispecific antibodies, antibody-drug conjugates
(ADCs), and covalent-inhibitor technologies to discover and develop
novel cancer treatments. Together, we are striving to outsmart
cancer. To learn more about us, please visit us at Counsel - Legal
Healthcare/Regulatory 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. Equal Opportunity Employer
Keywords: Pharmacyclics, LLC, Sunnyvale , Counsel - Legal Healthcare/Regulatory, Legal , Sunnyvale, California
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