Senior Counsel I - GTAL HIV Prevention

仕事内容

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. 

Join an amazing team supporting the HIV Prevention therapeutic area and help End the HIV Epidemic!

Sr Counsel I, GTAL – HIV Prevention

Gilead is looking for a Sr. Counsel to join our U.S. Therapeutic Area Legal Team (Business Conduct) to support Gilead’s HIV Prevention (and HIV Treatment) business.  This role is best filled by an individual working as a product attorney who also advises on compliance, fraud and abuse, anti-kickback and laws and regulations applicable to pharmaceutical promotion. Candidates with litigation experience representing pharmaceutical companies on these issues will also be considered.

This role is based in Foster City, CA, however consideration will be given to exceptional candidates commuting to Morris Plains, NJ and Remote candidates.

Working within the Global Therapeutic Area Legal Support (“GTAL”) team you will serve as a key business and 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 GTAL and US Pricing & Access, Commercial Legal teams, this attorney will take substantial responsibility for ensuring appropriate interactions with healthcare providers and others, and reviewing and monitoring promotional materials and activities, as well as business strategies and tactics, associated with one of the company's discrete therapeutic areas.

You will 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:

·Provide legal and compliance advice with a focus on commercialization, promotion, marketing and advertising of the Company’s approved product(s).  Support to a wide range of Company activities such as advising on promotional review, evaluating proposed corporate business plans, strategies, tactics, grant proposals, research activities, funding requests, competitor complaints, supporting regulatory actions, investigations, working groups, and drafting and updating Company compliance policies.

·Provide prompt review and guidance to the Promotional Review Committee (PRC) and Medical Review Committee (MRC).

·Monitor legal developments affecting pharmaceutical promotion and interactions with health care professionals. Provide recommendations to reduce risk and enhance operations.

·Develop an understanding of business objectives and how those translate into the Legal Department’s priorities to deliver practical advice and guidance to the business.

·Partner with the Global Therapeutic Area Legal Teams and other Therapeutic Area lawyers to enhance alignment and consistency of legal guidance, policy, and process.

• 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:

• Juris Doctorate from a nationally 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 (or other licensing requirements, as applicable).

• At least 6+ years prior in-house, law firm or regulatory 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 guidance’s, 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 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.

• This position is based in Foster City, California, however consideration will be given to exceptional candidates commuting to Morris Plains, New Jersey and Remote candidates.

Gilead Core Values:

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)