Clinical Regulatory Writing Intern - Remote

About the Role

We are seeking a Clinical Regulatory Writing Intern - Remote to join our innovative team at Ultragenyx Pharmaceutical. This is a unique opportunity for master's or PhD students to support the clinical regulatory writing team in the clinical development of treatments for rare and ultra-rare diseases. As a Clinical Regulatory Writing Intern, you will play a crucial role in developing high-quality clinical and regulatory documents for global marketing applications.

What You'll Do

• Participate in the authoring and review of clinical and regulatory documents.
• Learn and apply medical writing standards.
• Understand the process of distilling large amounts of clinical and scientific data.
• Perform literature-based research to support writing activities.
• Understand global and regional regulatory requirements.
• Liaise with clinical trial transparency colleagues.

Requirements

• Pursuing a Master’s degree or PhD in a scientific or medical field.
• 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 with strong organizational skills.
• Good verbal and written communication skills.

Nice to Have

• Experience in clinical regulatory writing.
• Familiarity with clinical trial processes.
• Previous internships in a related field.

What We Offer

• Generous vacation time and public holidays.
• Volunteer days.
• Long term incentive and Employee stock purchase plans.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.