Manager, Regulatory Affairs - Advertising & Promotion

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Job description

Manager, Regulatory Affairs - Advertising & Promotion
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. Gilead's 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 company's five core values. That's 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



Job Overview:

Provide commercial regulatory support to enable the US business to meet its commercial needs in a compliant manner. Supports or helps support one or more products or therapeutic areas.

Job Responsibilities:

Technical Skills:

• Provides commercial regulatory support to assigned products or therapeutic area and projects with managerial oversight, as appropriate. Conducts co-review and/or review & approval of promotional materials.
  
• Assists or serves as Promotional Review Committee Chair for one or more brands or therapeutic areas.
  
• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
  
• Approves and/or provides oversight of the submission of promotional materials to FDA, as needed.
  

Process Improvements:

• May initiate and/or contribute to local process improvements for activities that relate to regulatory advertising/promotion.
  

Strategic Influence:

• Provide regulatory guidance on new concepts and new campaigns with managerial oversight.
  
• Represent RA Ad/Promo at Regulatory Project Team meetings as needed.
  
• May attend labeling meetings as needed, with managerial oversight.
  

Leadership:

• Provides training to cross-functional team members as needed.
  
• Provides operational guidance on the submission of promotional materials to FDA.
  

Knowledge and Skills:

• Working knowledge of regulatory requirements associated with advertising and promotion of prescription drug and/or biologic products.
  
• Excellent interpersonal skills and ability to work on a number of projects are required.
  

Education and Experience:

• Typically requires a BA/BS degree and 4+ years of relevant experience, including 1-2 years of experience in the regulatory review of promotional materials for prescription/biologic drug and/or related experience
  
• Relevant education or training may be viewed as equivalent to, or a substitute for, work experience.
  

For jobs in the United States:
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 for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.

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