Clinical Regulatory Writing Intern

Summary

Join Ultragenyx as a Clinical Regulatory Writing Intern and contribute to the development of treatments for rare and ultra-rare diseases. This remote internship offers the opportunity to work closely with experienced professionals, authoring and reviewing clinical and regulatory documents. You will gain valuable experience in distilling complex data, conducting literature research, and understanding global regulatory requirements. The ideal candidate is a currently enrolled undergraduate or graduate student in a scientific or medical field with strong organizational skills and excellent communication abilities. Ultragenyx provides a supportive and inclusive work environment with various benefits, including generous vacation time, volunteer days, and professional development opportunities.

Requirements

• Currently pursuing a Bachelor's degree in a scientific or medical field, with at least one year of coursework completed. MS and PharmD students are also eligible
• Enrolled as a full-time student with plans to return to school in the fall term
• Able to work 35 hours/week during core business hours
• Knowledgeable with Microsoft Office Suite
• Strong organizational skills
• Meticulous attention to detail
• 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 and keeping manager informed of work status

Responsibilities

• Participate in the authoring and review of clinical and regulatory documents relating to global marketing applications and clinical trials
• 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 and use reference management software to incorporate citations into documents
• 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

Preferred Qualifications

Prior research experience is preferred, with additional consideration for candidates with experience in clinical trials

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