
Graduate Intern, Regulatory Writing
United States - California - Santa MonicaRegulatoryInternJob Description
We are seeking a 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 both regulatory approvals to conduct clinical trials and 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 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 therapy 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 will include, but are not limited to, the following:
Review text and tables of documents against source documents to ensure accuracy
Provide text describing methods 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:
Must be at least 18 years or older
Must be currently enrolled in a full-time graduate degree program at an accredited university/college
Must have completed at least one year of study at an accredited university/college prior to internship commencing
Must be enrolled in the Fall Semester at an accredited university/college after the completion of the internship - graduation date of December 2021 or Spring/Summer 2022
Must be able to complete a 10-12 consecutive week internship between June and September
Must be legally authorized to work in the U.S. without Kite sponsorship
Must 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
Minimum 3.0 cumulative GPA on a 4.0 scale
Proficiency with MS Office Suite
Ability to identify issues and seek solutions
Excellent verbal and written communication skills and affinity for writing
Ability to work in collaborate in cross functional teams in fast pace, rapidly changing environment
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
Some familiarity with basics of clinical trials for the development of drug and biological products is a plus