Senior Regulatory Affairs Associate Labeling
Senior Regulatory Affairs Associate Labeling
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
Great opportunity to join the Regulatory Affairs Global Labeling team as the primary support for Global Labeling compliance and process improvement. The Senior Associate in Regulatory Affairs Global Labeling performs a crucial role in providing data and summary reports from the labeling tracking system on Global Labeling compliance to department management; providing materials for Global Labeling audits and inspections; representing Regulatory Affairs Global Labeling on local and global process improvement initiatives; providing input on labeling system requirements for upgrades or enhancements; supporting User Acceptance Testing; supporting training for new users; creating and maintaining labeling tracking system SOPs, Work Instructions, Job Aids and User Guides; and supporting the maintenance of Global Labeling SOPs, Work Instructions, and best practices.
- With a Senior Regulatory Affairs Global Labeling team member, represents Regulatory Affairs Global Labeling as a system business owner on maintenance of the labeling tracking system.
- Creates and maintains Safety Variation Metrics deliverables and provides summary reports to department management and designated stakeholders, including supporting the preparation of the Pharmacovigilance System Master File (PSMF) Annex F report.
- Supports responses to inquiries from Gilead colleagues in response to audit activities and may provide support during regulatory agency inspections.
- Supports Global Labeling Corrective and Preventative Actions (CAPAs).
- Supports bi-annual compliance updates for US labeling in Structured Product Labeling (SPL) format for posting on Daily Med.
- Supports maintenance of, and leads training on, Global Labeling automation process for Company Core Data Sheet distribution.
- Represents Regulatory Affairs Global Labeling on artwork system upgrades and training.
- Acts as owner for specific labeling best practices and assumes role of documentation subject matter expert.
- Runs training and awareness sessions on labeling processes and expectations to stakeholders.
- Identifies incremental improvements to labeling-related processes and systems for exploration by more senior labeling managers.
- Supports maintenance of Global Labeling SharePoint page.
Knowledge & Skills:
- Solid understanding of systems and electronic technologies used to support regulatory submissions and records management.
- Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed.
- An understanding of pharmaceutical labeling systems and processes.
Education, Skills & Experience:
- 5+ years of relevant training or industry experience with BS/BA.
- 3+ years of relevant training or industry experience with advanced degree.
- Degree in a scientific field is preferred.
- Strong organizational skills and ability to work on several projects in alignment with timelines.
- Strong verbal and written communication skills and interpersonal 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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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