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:

ultradedicated – Your biggest challenges yield rare possibilities

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.

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 (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

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

U.S. Hourly Wage Range:

• $30.00-$40.00 per hour. The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level

#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 or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: [email protected].