Sr Manager, Regulatory Affairs - Advertising and Promotions (Remote)

Location
Foster City
Salary
See job description.
Posted
November 18 2020
Ref
R0012303
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Sr Manager, Regulatory Affairs - Advertising and Promotions (Remote)
United States - California - San Diego

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


Senior Manager, Regulatory Affairs, Advertising and Promotion

Job Overview:

As a member of the Regulatory Affairs, Advertising and Promotion (RA Ad/Promo) group, provide commercial regulatory support to enable the US business to meet its commercial needs in a compliant manner. Support one or more high volume products or therapeutic areas.

Job Responsibilities:

Technical Skills:

  • Provide commercial regulatory support to assigned products or therapeutic area and projects with minimal managerial oversight, as appropriate. Conduct review and approval of promotional materials.

  • Serve as Promotional Review Committee Chair for one or more high volume brands or therapeutic areas.

  • Serve as regulatory liaison to FDA/CDER/OPDP for assigned products, with managerial oversight.

  • Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.

    Process Improvements:

  • May initiate and/or contribute to local or global process improvements for activities that relate to the RA Ad/Promo group.

    Strategic Influence:

  • Provide regulatory guidance on new concepts and new campaigns with managerial oversight, as appropriate.

  • Represent RA Ad/Promo at Regulatory Project Team meetings.

  • Represent RA Ad/Promo at labeling meetings and provide strategic regulatory guidance, with managerial oversight, as appropriate.

    Leadership:

  • Mentor RA Ad/Promo team members and provide training to cross-functional team members, as needed.

    Knowledge and Skills:

  • In-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products is desirable.

  • Excellent interpersonal skills and ability to work on a number of projects are required.

    Education and Experience:

  • Typically requires a BA/BS degree and 6+ years of relevant experience, including 2-4 years of experience in the regulatory review of promotional materials for prescription drug and/or biologic products.

  • Relevant education or training may be viewed as equivalent to, or a substitute for, work experience.

    #LI-CS2

    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 careers@gilead.com for assistance.

    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.


    To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---San-Diego/Sr-Manager--Regulatory-Affairs---Advertising-and-Promotions_R0012303





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