Intern - Regulatory Intelligence

Employer
Gilead Sciences, Inc.
Location
Foster City, California
Salary
See job description.
Posted
Mar 17, 2021
Closes
Apr 09, 2021
Ref
539022
Jobseeker Type
Professional
Organization Type
Corporate
Hours
Part Time
Intern - Regulatory Intelligence
United 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. 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

A research project and other professional development opportunities is available in the Regulatory Affairs (RA), Global Regulatory Policy and Intelligence (GRPI) function at Gilead.

The research project will allow the participant to use and build Regulatory Policy and Intelligence skills and methods to analyze the Gilead Sciences portfolio. The project will have a strong focus on Gilead non-cell therapy oncology products. Research will be conducted using quantitative and qualitative analyses to address operational needs and serve RA and Development function.

The Regulatory Intelligence Project

  • This project will assess the impact of US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the International Council for Harmonization (ICH guidelines) supporting the Gilead oncology portfolio.


The participant will:

  • Conduct background research related FDA, EMA and ICH guidelines or other data need identified to support Gilead non cell therapy oncology pipeline products;
  • Identify potential areas where guidance clarity is necessary, outdated or new references may be forthcoming;
  • Partake in the development of research methodology and project plan; through contributing relevant research;
  • Compile and analyze relevant qualitative and quantitative data;
  • Present findings in a deliverable of professional quality and presentation to the broader team; and
  • Potential submission of the project, in article form, to the Regulatory Affairs Professional Society.


Other Professional Development Opportunities

  • Outside of the Project, other professional development opportunities will be presented.


The participant will:

  • Meet weekly with a mentor to develop research methodology and science policy skills
  • Join GRPI team meetings; and
  • Collaborate and work with the (GRPI) team.


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--Remote/Intern---Regulatory-Intelligence_R0017992-1

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