AbbVie Senior Counsel - Legal Healthcare/Regulatory in Sunnyvale, California
Senior Counsel - Legal Healthcare/Regulatory
Location: Sunnyvale, CA
# of Openings: 1
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 athttp://www.pharmacyclics.com/
Senior Counsel – Legal Healthcare/Regulatory
General Position Summary/Purpose:
Senior 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 8+ years of relevant experience.
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.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled