Medical Writer I (CTT)

About the role

Serves as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects.

What you'll do

• Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision
• Clinical study protocols and clinical study protocol amendments
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards

What you need

• 1–4 yrs of experience
• Writing
• Regulatory affairs
• SOP writing
• Editing
• Customer success
• Any graduate