Intern, Clinical Regulatory Writing

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

This is a unique opportunity for an undergraduate student to support the clinical regulatory writing team in the research and development of treatments for rare and ultra-rare diseases. The clinical regulatory writing intern will work closely with the clinical regulatory writing and cross-functional teams to develop high quality clinical and regulatory documents for global marketing applications or other submission needs.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

 

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

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

#LI-AJ1    #LI-REMOTE

  Full Time employees across the globe enjoy a range of benefits, including, but not limited to:   ·         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   * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses o