Senior Medical Writer

Job Summary

Working remotely from any location in Colombia, the full-time Senior Medical Writer will critically evaluate medical literature, write and edit clinical development documents, and manage timelines for writing assignments in the pharmaceutical industry.

Key responsibilities

• Critically evaluate and interpret medical literature to inform study design and regulatory submissions
• Write and edit various clinical documents, including protocols, reports, and consent forms
• Interact directly with clients to coordinate project facets and mentor other writers on the team

Required qualifications

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