Intern, Clinical Regulatory Writing

Ultragenyx Pharmaceutical

21h•$30 - $40•Remote

About The Position

This is a unique opportunity for either master's or PhD students to support the clinical regulatory writing team in the clinical development of treatments for rare and ultra-rare diseases. The clinical regulatory writing intern will work closely with the medical writing and cross-functional teams to develop high quality clinical and regulatory documents for global marketing applications.

Requirements

Pursuing a Master’s degree or PhD. in a scientific or medical field with minimum of first year completed
Understanding of basic biology, clinical research, and medical terminology
Enrolled as a full-time student
Able to work 40 hours/week during normal business hours
Proficient with Microsoft Office Suite
Knowledgeable regarding the use of AI tools
Detail orientated, strong organizational skills
Flexible; adapts work style to meet organizational needs
Good verbal and written communication skills; ability to write clearly and effectively
Capable of completing assigned responsibilities within timelines and providing their manager with project status updates

Responsibilities

Participate in the authoring and review of clinical and regulatory documents relating to global marketing applications and clinical trials (eg, clinical study reports, protocols, safety narratives)
Learn and apply medical writing standards
Understand the process of distilling large amounts of clinical and scientific data into essential elements for tabular and graphical display
Perform literature-based research to support writing activities
Begin to understand global and regional regulatory requirements (eg. ICH E3) and how they impact clinical and regulatory writing
Liaise with clinical trial transparency colleagues to understand how data from clinical and regulatory documents is disclosed publicly