This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

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.

• Participate in the authoring and review of clinical and regulatory documents relating to global marketing applications and clinical trials (e.g., 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 (e.g., 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

Qualifications

• Pursuing a Master’s degree or PhD in a scientific or medical field with a 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 oriented, 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

Requirements

• U.S. Hourly Wage Range: $30.00-$40.00 per hour
• The actual hourly wage offered will depend on the candidate’s school year/level

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
• Benefits vary by region and country