Intern, Clinical Regulatory Writing
Ultragenyx
internship
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $30 - $40 per hour
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingclinical researchliterature-based researchdata distillationregulatory writingbiological knowledgemedical terminology
Soft Skills
detail orientedorganizational skillsflexibilityverbal communicationwritten communicationtime management