Medical Writer

Job Summary

Leading the writing process for clinical and regulatory documents, the full-time Medical Writer will support the international roll-out of a prostate cancer imaging agent and contribute to late clinical-stage product advancement, working in a hybrid environment.

Key responsibilities:

• Compile, write, and edit high-quality regulatory documents including clinical study reports and Investigator Brochures
• Interpret scientific and statistical data, analyze published literature, and compose text based on findings
• Collaborate with project teams and respond to health authority inquiries in a timely manner

Required qualifications:

• Bachelor's degree in a science-related field; advanced degree preferred
• 5+ years of experience in regulatory medical writing
• Strong understanding of drug development, clinical study design, and relevant regulations
• Experience in writing clinical protocols, clinical study reports, and eCTD summary documents
• Proficiency in Microsoft Word and strong command of the English language