Senior Associate, Regulatory Affairs - Advertising & Promotion

Location
Foster City
Salary
See job description.
Posted
August 25 2021
Ref
R0021729
Position Type
Full Time
Organization Type
Pharma
Job Type
Technician


Senior Associate, 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. 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



Specific Responsibilities & Skills:

The Senior Associate in Regulatory Affairs, Advertising and Promotion (RA Ad/Promo) is responsible for providing operational support in the area of advertising and promotion pertaining to US marketing activities and products. This role will support one or more high volume brands and/or therapeutic areas as needed based on business priorities. The Senior Associate will report to an Associate Director or above in RA Ad/Promo, and will manage the submission of promotional materials for marketed prescription drug or biologic products to FDA's Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB) at the time of first use. The Senior Associate will track and adhere to strict timelines for these and all FDA/OPDP/APLB submissions. Additionally, the Senior Associate may manage Subpart H and launch advisory submissions for promotional materials to OPDP/CBER/APLB, as well as track and adhere to deadlines associated with these submissions. The Senior Associate will maintain and update internal archives as well as track relevant internal metrics. They will also initiate, contribute to, and create documentation for local process improvements, and will represented RA Ad/Promo on Regulatory Affairs working groups, as needed. The Senior Associate must be capable of collaborating with other groups within and outside Regulatory Affairs to ensure the publication of compliant, high-quality, and timely FDA/OPDP submissions. This position will also provide strategic support to members of the RA Ad/Promo group by conducting regulatory specific research and monitoring of the external RA Ad/Promo environment. As a leader, the Senior Associate will train external agencies on Gilead submission processes. They will also support and coordinate the training of new Associates in the RA Ad/Promo group, provide guidance to other Associates on best work practices for events without formalized consistency documents, and support managing specific cross-functional and intra-functional issues.

Knowledge, Experience and Skills:
  • Typically requires a BA degree and 5+ years of Regulatory industry experience.
  • An in depth understanding of the role of Regulatory Affairs and familiarity with regulatory submission requirements for promotional materials is required.
  • Familiarity with Veeva Vault is preferred.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Excellent attention to detail, organizational skills, and the ability to work on several projects with tight timelines with limited to no supervision, are required.

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/Senior-Associate--Regulatory-Affairs---Advertising---Promotion_R0021729-1





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