Intern - Regulatory Affairs - Virology focus in Hepatitis

Intern - Regulatory Affairs - Virology focus in Hepatitis
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:

Under the supervision of the regulatory affairs manager, the intern will work with various team members in the Gilead Virology Group, focusing on the area of hepatitis, to support regulatory activities in the United States and potentially other countries for marketed and investigational products.

Essential Functions:

Support projects aligned with goals of the regulatory liaison team including, but not limited to:

• Assisting with regulatory submissions like clinical study reports, protocol amendments, aggregate reports, and Investigational New Drug/New Drug Applications (IND/NDA)
• Conducting regulatory precedence-based research and presenting findings
• Maintaining and creating regulatory resources
• Contributing to process improvement initiatives
• Performing workflows and procedures following Standard Operating Procedures (SOPs) regarding document tracking, indexing and retrieving, and disseminating information

Essential Experience and Skills:

• Undergraduate or graduate student enrolled in an accredited university/college
• Major in regulatory science, pharmacy, biology, chemistry, or related field
• Strong attention to detail and excellent organization, verbal, and written communication skills
• Ability to work both independently and collaboratively on assignments
• Ability to prioritize work while managing multiple tasks simultaneously
• Computer experience must include advanced software skills with Word, Excel and PowerPoint

Desirable Knowledge, Experience, and Skills:

• Prior coursework or experience in drug-related regulatory affairs
• Understanding of change management and/or implementation and dissemination science
• Experience with Microsoft Project/Visio

Other Information:

• Resumes should be 1-2 pages in length and an associated cover letter is highly recommended
• Candidate must commit to 10-12 consecutive weeks of full-time work between May and Sep.
  • Highly encouraged this position is the only workrelated commitment from May to Sep.
• No relocation is available for this position; it is highly likely the position is remote
• Leveling is dependent on relevant experience

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.

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


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/Intern---Regulatory-Affairs---Hepatitis_R0017748-1





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