Data Administration Associate, Regulatory CMC Systems

Location
Foster City
Salary
See job description.
Posted
February 12 2021
Ref
R0017367
Position Type
Full Time
Organization Type
Pharma
Job Type
Technician

 


Data Administration Associate, Regulatory CMC Systems
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


Data Administration Associate, Regulatory CMC Systems

Specific Job Responsibilities

 

 

 

  • Utilize Gilead Information Systems to enter and maintain relevant product information to support Regulatory Affairs CMC, Quality Assurance and other cross-functional stakeholders.
  • Work collaboratively with RA CMC staff to meet deliverables and timelines for routine data acquisition, data entry, data quality control and reporting.
  • Ensure completeness, correctness and consistency of RA CMC data and data structure.
  • Manage tracking spreadsheet for commercial change controls that have regulatory impact.
  • Responsible for supporting project work for enhancements to information systems for RA CMC and external stake holders who utilize RA CMC data.
  • Responsible for preparing FDA requests for CPP certificates.
  • Responsible for development and acquisition of required regulatory database skills and knowledge; training supported by manager and peers.
  • Act as a resource on topics within the department.
  • Contribute to local process improvements, which have an impact on the working of the RA CMC function or other departments.
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals.

 


Knowledge & Skills

 

 

 

 

  • Strong verbal, written communication, and interpersonal skills.
  • Excellent organization skills.
  • Able to work on multiple concurrent projects with tight timelines.

 


Required Education & Experience

 

 

 

 

  • A Bachelor's Degree and a minimum of four (4) years of work experience.
  • Familiarity with web-based Electronic Data Capture (EDC) and data management systems.

 


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

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/Data-Administration-Associate--Regulatory-CMC-Systems_R0017367





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