Sr. Regulatory Ops Associate

Location
Foster City, CA, United States
Posted
Jun 13, 2021
Ref
2261447
Required Education
Bachelors Degree
Position Type
Full time
Sr. Regulatory Ops Associate
United States - California - Foster CityUnited States - Remote

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

We are looking for an enthusiastic and dedicated Senior Publisher to join our diverse RegOps team.

You will be responsible for publishing electronic documents and building regulatory submissions as well as leading submission teams ensuring high quality and on-time delivery. If you like challenge, are passionate about learning and continuously developing your skill set, this position is for you. You will be often solving complex, submission related, technical problems and guiding others in different functional areas.

Attention to details, excellent communication, ability to take the lead and work under pressing deadlines will help you to succeed as a Senior Publisher in our group.

Core responsibilities:
  • Electronically formats and publishes electronic documents; builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory Agency guidance and specifications, and internal procedures.
  • Provides guidance on good documentation and submission practices to project teams.
  • Coordinates submission timelines and content plans.
  • Identifies and communicates process opportunities for improvement and regulatory system enhancement needs or technical issues.


Qualifications:
  • BS/ BA with minimum 5 years or MA/ MS with 3 years of experience in Regulatory Operations with submissions responsibility.
  • Strong familiarity with applicable FDA, CA and ICH guidelines related to regulatory submissions, clinical trials and marketing applications.
  • Working knowledge of eCTD publishing systems, EDMS technology
  • Clear understanding of regulatory submission content and format requirements.
  • Experienced in lifecycle management of various eCTD submissions
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has effective written and verbal communication skills.


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.
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