Intern CMC Regulatory Affairs - Biologics

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Job description

Intern CMC Regulatory Affairs - Biologics
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. 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

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Intern - CMC Regulatory Affairs - Biologics

Foster City, CA

As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs.

A summer internship is available in the Regulatory Affairs CMC (chemistry, manufacturing and controls) Department at the Foster City, CA, campus of Gilead Sciences. The candidate should be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line with regulatory requirements, company policies and procedures.

Key Responsibilities will include, but are not limited to the following:

• Under general supervision and guidance of RA CMC Foster City team, develop required regulatory skills and knowledge for assisting in the preparation of regulatory submission documents including notifications, supplements and annual reports to clinical trial applications and marketing authorizations for assigned territories, as applicable.
  
• May contribute to local process improvements with potential impact to the Regulatory Affairs CMC Department, including but not limited to computerized information, regulatory and change control systems.
  
• Analyze previously received Health Authority questions & answers and commitments to summarize regulatory trends and expectations.
  
• Work cross-functionally within a matrixed organization.
  
• Showcase your work with a final presentation (PPT) near the conclusion of your internship
  

Required Qualifications:

• Must be at least 18 years old
  
• Must have a minimum GPA of 2.8
  
• Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University.
  
• Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall semester after the completion of the internship.
  
• Must be a Rising Sophomore, Junior, or Senior in undergrad or enrolled in an advanced degree program.
  
• Must be able to complete a 10-12 consecutive week internship between May and August
  
• Must be able to relocate if necessary and work at the designated site for the duration of the internship.
  

Preferred Qualifications:

• Preferred Degree qualification: Undergraduate/Graduate
  
• Proficiency with MS Office Suite
  
• Ability to identify issues and seek solutions
  
• Ability to work both independently and collaboratively
  
• Demonstrated commitment to inclusion and diversity in the workplace
  
• Efficient, organized, and able to handle short timelines in a fast-paced environment
  

Gilead Core Values:

• Integrity (Doing What's Right)
  
• Inclusion (Encouraging Diversity)
  
• Teamwork (Working Together)
  
• Excellence (Being Your Best)
  
• Accountability (Taking Personal Responsibility)
  

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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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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