Job Description Specific Responsibilities and Skills This function will best be served by an individual with experience working as a product attorney who also advises on compliance, fraud and abuse, and laws and regulations applicable to pharmaceutical promotional . Other candidates with litigation experience representing pharmaceutical companies on these issues are also considered.
Working within the Business Conduct team, serve as a strategic partner, and legal and compliance resource to the commercial business to ensure appropriate and compliant promotional practices under applicable FDA and other statutory and regulatory requirements. Under appropriate supervision and in collaboration with colleagues on the Business Conduct and Commercial Legal teams, take substantial responsibility for reviewing and monitoring promotional materials and activities, as well as business strategies, associated with one of the company's discrete therapeutic areas. Contribute to the periodic review, revision and supplementation of corporate and commercial compliance policies, procedures, training and monitoring to ensure they appropriately reflect legal and regulatory developments. This role will also support Medical Affairs as well as Public Affairs, and other company departments as needed, and contribute legal input to cross-functional groups and projects as they arise.
Responsibilities include, but are not limited to: • Appropriately triage a heavy workflow, setting appropriate priorities with clients and delivering results within the reasonable agreed timelines. • Demonstrate ability to think creatively and devise solutions to challenging problems. • Advance a positive spirit of solution-oriented partnership and collaboration with internal clients, internal legal colleagues and outside counsel. • Exercise mature and reliable judgment while enjoying the company's enthusiastic, informal and fast-paced environment. • Recognize and escalate matters of specialty, or unusual complexity or risk as appropriate
Qualifications • Have a Juris Doctorate from a nationally recognized accredited law school. • Be a member in good standing of the State Bar of California, or ability to acquire status of Registered In-House Counsel from the California Bar • At least 4+ years prior in-house or law firm experience providing legal counsel on the laws and regulations relating to drugs or devices, demonstrating growth and ability to succeed. • Detailed knowledge of Food and Drug Administration and other government regulation of marketing and advertising of pharmaceutical products is very helpful. • Familiarity with these additional areas is also helpful: Anti-Kickback Statute, False Claims Act, HIPAA, privacy-laws, advertising laws and regulatory guidances, and legal contract principles. • Must have demonstrated high EQ and client-service orientation; able to recognize and respond quickly and pragmatically to urgent situations and demanding clients. • Must have demonstrated skills, depth and expertise depending in area(s) of responsibility. • Have exceptional and demonstrated written and verbal communication skills.
Other: • This position requires demonstration of Gilead's core values: Teamwork, Accountability, Inclusion, Excellence and Integrity • This position requires working within a team extensively and accordingly, the ability to work collaboratively and efficiently with others is absolutely critical. You must possess strong interpersonal skills, EQ, professionalism and the ability to work well with a variety of different personalities to be successful in this role. • While Gilead does permit occasional, reasonable requests for telecommuting, this is predominately an "in-office" position.
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