Ultragenyx

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Intern, Clinical Regulatory Writing

InternshipRemoteTeam 501-1,000Since 2010H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

$30 - $40 / hour

Postgraduate DegreeEnglish

Job Description

• 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

Job 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

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

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