Senior Medical Writer

Job Summary

Working remotely from any location in Brazil, the full-time Senior Medical Writer will critically evaluate medical literature, write and edit clinical development documents, and manage writing assignments while interacting directly with clients.

Key responsibilities

• Evaluate and interpret medical literature to support study design and regulatory submissions
• Write and edit various clinical documents, including protocols, reports, and consent forms
• Maintain timelines and workflow for writing assignments while providing mentorship to team members

Required qualifications

• At least 3-5 years of regulatory writing and clinical medical writing experience in the pharmaceutical industry
• Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline
• Substantial experience as a lead author on clinical study protocols
• Expert proficiency in MS Word, Excel, and PowerPoint
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines