Dir, Regulatory Affairs - Ad Promo

Location
Foster City
Salary
See job description.
Posted
November 18 2020
Ref
R0014427
Position Type
Full Time
Organization Type
Pharma


Dir, Regulatory Affairs - Ad Promo
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


Within the Regulatory Affairs Advertising and Promotion (RA Ad/Promo) group at Gilead, provide commercial regulatory strategy and leadership to enable the US business to meet its commercial needs in a compliant manner. Support multiple complex products and/or therapeutic areas, either individually or through the oversight of direct reports. Manage a team of 1 or more direct reports according to business need.

Job Responsibilities:

Technical Skills:

  • Represent the commercial regulatory perspective at and effectively chair high volume PRC meetings for complex brands.

  • Serve as regulatory liaison to FDA/CDER/OPDP for assigned products.

    Process Improvements:

  • Initiate, contribute to, or lead local and global process improvements that have a significant impact on the business.

    Strategic Influence:

  • May be required to assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling.

  • May be required to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.

  • May be required to assume a leadership role in updating and advising cross-functional stakeholders on regulations, policies, and enforcement which may impact the company's promotional activities.

    Leadership:

  • Lead and manage a team of direct report(s), according to business needs. Direct reports are typically independent contributors.

  • Develop and coach direct reports and ensure they are appropriately trained.

    Knowledge and Skills:

    • Must have in-depth knowledge of regulatory requirements associated with US Advertising and Promotion of prescription drug and/or biologic products.
    • Must have the ability to understand and evaluate competing perspectives and provide expert commercial regulatory guidance.
    • Excellent verbal and written communication skills and interpersonal skills are required.


    Education and Experience:

  • Typically requires a BA/BS degree and 10+ years of relevant experience, including 6-8 years of experience in the regulatory review of promotional materials for prescription drug and/or biologic products. or 8 + years experience with a MD or PhD

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

  • Management experience is preferred.

  • Direct experience working with FDA/CDER/OPDP or FDA/CBER/APLB is preferred.

    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---Foster-City/Assoc-Dir--Regulatory-Affairs---Ad-Promo_R0014427





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