Sr Counsel, Global Medical Affairs Business Conduct Attorney
Sr Counsel, Global Medical Affairs Business Conduct Attorney
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Being here matters. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
The Medical Affairs Business Conduct attorney is responsible for providing legal support to the global Medical Affairs department. The primary client for this role is the Medical Affairs department but will also be responsible for interacting and managing projects with Public Affairs, Government Affairs and Clinical. This role also requires working closely with colleagues who support Gilead products, Global Compliance, Privacy, and Regulatory. The attorney will be expected to collaborate with attorneys in our International Legal, Pricing and Access, Competition Law, Intellectual Property and other legal functions.
The Global Medical Affairs Business Conduct attorney provides legal and compliance input into global strategies and tactics related to a wide range of topics, e.g., patient-centric activities and publication strategy, and drives alignment and consistency across the various therapeutic areas in which Gilead has commercialized or will be commercializing products. Broadly speaking, the role is responsible for collaborating with Medical Affairs management to ensure compliant interactions with healthcare professionals, patients, charitable organizations and third parties retained by our business on appropriate dissemination of scientific information. The Global Medical Affairs Business Conduct Attorney would also conduct, assist and/or provide input into our business conduct policies, training, monitoring, auditing, communications, enforcement, and defense of investigations.
The role is based in Foster City, California, reporting into the Global Therapeutic Area Legal group within the Commercial Legal Department.
This role requires a person that can identify, communicate, coordinate and manage various issues, projects and initiatives simultaneously and across geographies and cultures. This role also requires a person who can proactively engage stakeholders in advising on legal issues and coming to appropriate resolutions in a timely manner.
Essential Duties and Job Functions
- Providing guidance and approval to Medical Affairs, and any related sub-teams with respect to various initiatives ranging from ISRs and other Phase IV trials, Medical Information, compassionate use, publications management and interactions between field personnel and external stakeholders.
- Acting as a point-of-contact between Medical Affairs with other Legal teams related to projects and activities, specifically coordinating with such counsels to help ensure alignment and understanding of the global initiatives, e.g., publications, ISRs etc.
- Collaborating with various cross-functional departments on communications and management of our clinical trials to help ensure alignment and consistency with Gilead's policies and procedures.
- Partnering with the Global Therapeutic Area Leads within the Global Therapeutic Area Legal team to ensure alignment and consistency in the advice provided to Medical Affairs.
- Partnering with the Global Compliance Team to provide insights into Training and Monitoring, as well as, with Risk Assessments/Anti-Bribery-Anti-Corruption, and Value and Access to coordinate our global efforts.
- Have a Juris Doctorate from a nationally recognized accredited law school.
- Admission to applicable state bar, registration as in-house counsel, or ability to gain admission or registration for either in applicable state within 90 days.
- 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
- 8-10 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-having prior experience working with Medical Affairs or a similar function is a strong plus.
- Detailed knowledge of the US Anti-Kickback Statute, False Claims Act, HIPAA, privacy-laws, advertising laws and regulatory guidances, Food, Drug and Cosmetic Act and other government regulation of pharmaceutical products OR similar laws internationally is required.
- Familiarity with these additional areas is also helpful: Foreign Corrupt Practices Act and other relevant anti-bribery laws, guidance on Patient-Focused Drug Development activities, 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.
- Operates at a high level of autonomy and who has proven that he or she is able to very competently lead a complex area of responsibility or department that requires significant experience.
- Has proven judgment in working through complex issues, including those with significant strategic risk to the company. Developing ability to apply judgment to areas outside of core competency.
- Leadership and project management in crossfunctional projects, and willingness to take initiative
- Excellent written and verbal communications skills
- Excellent analytical and problem-solving skills
- Detail-oriented and well-organized
- 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.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
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