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Graduate Intern, Regulatory Affairs

United States – RemoteClinical Development & Clinical OperationsIntern
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Job Description

We are seeking highly motivated and passionate individuals to join our Summer Internship Program! As an intern at Kite, you’ll have the unique opportunity to learn about cell therapy from some of the brightest minds in biotech while making a meaningful impact. We’re committed to developing early talent, and we welcome motivated individuals with a passion for transforming the way cancer is treated. The program also offers the opportunity for networking within Kite and Gilead, social events with fellow interns and Kite leadership as well as career development trainings while providing competitive compensation and relocation assistance for eligible candidates.

The Role:

Kite Regulatory Writers develop regulatory submission documents that support the conduct of clinical trials and ultimately regulatory approval to market our cell therapy products in the US, European Union, and other regions. We collaborate closely with colleagues in Regulatory Affairs, Safety, Clinical Development, Clinical Operations, and Biostatistics. We are also responsible for writing and ensuring both the accuracy and overall quality of reports, summaries, and other documents submitted to global regulatory agencies. Writers also support the development of background sections, including scientific literature reviews.

The Regulatory Writing intern will have the opportunity to develop an understanding of regulations and guidance as they relate to development of documents for Kite’s cell therapeutic products. You will also learn about the role and responsibilities of key functions that work closely with Regulatory Writers. You will receive mentorship from senior writers and have an opportunity to support the development of one or more documents for Kite products.

Responsibilities:

  • Review text and tables of documents against source documents to ensure accuracy

  • Provide text describing methods and/or results for a subsection of a regulatory submission document

  • Ensure consistency and accuracy of citations

  • Shadow selected medical writing team members for short periods to develop an understanding of regulations and guidance related to the development of documents for Kite’s cell therapy products

  • In collaboration with the Kite mentor, liaise with internal subject matter experts (SMEs) to summarize key data conclusions obtained in clinical studies

  • Attend internal medical writing team meetings to review project status and deliverables

Basic Qualifications:

  • 18 years or older

  • Minimum GPA of 2.8

  • Eligible to work in the United States without work authorization sponsorship now or in the future

  • Currently enrolled in a full-time graduate degree program at an accredited U.S. based university/college

  • Completed at least one year of study at an accredited university/college prior to internship commencing

  • Enrolled full-time in the Fall Semester at an accredited U.S. based university/college after the completion of the internship – with earliest graduation date of December 2024 or Spring/Summer 2025

  • Able to complete a 10-12 consecutive week internship between May and August

  • Able to relocate if necessary and work at the designated site for the duration of the internship

  • Not be employed at the time the internship starts

Preferred Qualifications:

  • Currently enrolled in Graduate Degree with emphasis in Biologic Science, Regulatory Science, Pharmaceutical Sciences, Bioengineering or similar related degree programs

  • Proficiency with MS Office Suite

  • Ability to identify issues and seek solutions

  • Ability to work both independently and collaboratively/Ability to work in collaborate in cross functional teams in fast pace, dynamic team setting

  • Efficient, organized, and able to handle short timelines in a fast-paced environment

  • Experience and/or interest in the Biotechnology, Pharmaceutical or health-care industry

  • Knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory policies

  • Excellent verbal and written communication skills and affinity for writing

  • Some familiarity with basics of clinical trials for the development of drug and biological products