[Remote] Intern, Clinical Regulatory Writing

Note: The job is a remote job and is open to candidates in USA. Ultragenyx Pharmaceutical is dedicated to leading the future of rare disease medicine. The Clinical Regulatory Writing Intern will support the clinical regulatory writing team in developing high-quality clinical and regulatory documents for global marketing applications, working closely with cross-functional teams.

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

Skills
• 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 oriented, 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

Benefits
• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans

Company Overview
• Leading with purpose. Every day. It was founded in 2010, and is headquartered in Novato, California, USA, with a workforce of 1001-5000 employees. Its website is http://www.ultragenyx.com.

Company H1B Sponsorship
• Ultragenyx has a track record of offering H1B sponsorships, with 11 in 2025, 10 in 2024, 17 in 2023, 16 in 2022, 16 in 2021, 4 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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