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Gilead

Intern - PDM - CMC Regulatory Affairs, Strategy and Operations

LocationUnited States - California - Foster City
Work modehybrid
Typeinternship
DepartmentPDM - CMC Regulatory Affairs, Strategy and Operations
Company size10,000+ people
First seen2w ago
Last seen4d ago
About the company
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 - PDM - CMC Regulatory Affairs, Strategy and Operations
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.
Key Responsibilities will include, but are not limited to the following:
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Support definition and early design of a governed AI-enabled capability intended to simulate elements of health authority review of CMC regulatory submissions.
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Work with CMC Regulatory Affairs subject matter experts to understand how experienced regulatory reviewers assess Module 3 content and identify potential deficiencies, inconsistencies, missing rationale, and likely areas of regulatory questioning.
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Research relevant health authority guidance, regulations, review practices, and publicly available regulatory information to inform the design of the capability.
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Support development and testing of an early minimum viable product or prototype using approved technologies and information sources.
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Develop approaches for evaluating the quality and usefulness of outputs, including identification of false positives, unsupported conclusions, missed issues, and other limitations.
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Support Regulatory Policy & Advocacy colleagues in researching and assessing emerging health authority requirements, regulatory guidance, policy developments, and industry trends.
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Explore opportunities to apply AI and automation to regulatory intelligence activities, including information identification, synthesis, classification, and retrieval.
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Showcase your work with a final presentation (PPT) near the conclusion of your internship
Required Qualifications:
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Must be at least 18 years of age at the start of the internship.
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Must be enrolled full‑time in a Bachelor’s, Master’s, MBA, JD or PhD program at a nationally accredited U.S. college or university, with continued full‑time enrollment required in the Fall semester following the internship.
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Must be currently enrolled as an undergraduate (freshman, sophomore, junior, or senior) or as a graduate/doctoral student.
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Must have a minimum overall cumulative GPA of 2.8 at the time of application and hire (official transcripts will be requested).
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Must be independently authorized to work in the United States now and in the future (current or future work authorization must not require school or employer sponsorship).
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Must be able to commit to a full‑time internship lasting 10–12 consecutive weeks between May and August.
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Must be willing and able to work at the designated site for the duration of the internship (relocation may be required). All internships are hybrid; fully remote roles are not offered.
Preferred Qualifications:
•
Preferred degree level: Graduate, MBA
•
Preferred field of study: Computer Science, Statistical Programming, Epidemiology, Biostatistics, Chemical Engineering, Molecular and Cell Biology, Biochemistry, Physics, Mathematics, Materials Science, Biology, Chemistry, or a related discipline
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Proficiency with Microsoft Office (MS Office) tools, such as Word, Excel, PowerPoint, and Outlook
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Strong problem‑solving skills, with the ability to identify issues and proactively seek solutions
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Ability to work effectively both independently and as part of a team in a collaborative environment
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Demonstrated commitment to inclusion and diversity, including the ability to work respectfully with individuals from diverse backgrounds
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Highly organized, detail‑oriented, and able to manage competing priorities in a fast‑paced environment with short timelines
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Strong interest in pharmaceutical development, Regulatory Affairs, artificial intelligence, or the intersection of science, regulation, and emerging technology.
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Familiarity with generative AI, large language models, data science, automation, or related technologies is desirable
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Ability to conduct structured research, synthesize information from multiple sources, and communicate findings clearly.
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Comfortable working with ambiguity and contributing to an early-stage project where the solution and approach will evolve through experimentation.
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Interest in understanding the limitations and risks of AI and designing approaches that preserve appropriate human judgment and oversight.
Gilead Core Values:
•
Integrity (Doing What’s Right)
•
Inclusion (Encouraging Diversity)
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Teamwork (Working Together)
•
Excellence (Being Your Best)
•
Accountability (Taking Personal Responsibility)
Benefits
The expected hourly range for this position is $20.00 - $55.00.
Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary.
Benefits include paid company holidays, sick time, and housing stipends for eligible employees.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 protected] 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
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, © consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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 apply via the Internal Career Opportunities portal in Workday.
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