Graduate Intern, Regulatory Affairs

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Posted
Nov 18, 2020
Ref
R0015851
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

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

Job 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 enrolledin 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


Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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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 contactcareers@gilead.comfor assistance.

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For Current Kite Pharma Employees and Contractors:

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