Plain Language Summary Writer

Job Summary

A company is looking for a Plain Language Summary Writer (Remote) for their Regulatory and Medical Writing Team.

Responsibilities:

• Critically evaluate, analyze, and interpret medical literature for study design, statistical significance, scientific rigor, and absence of bias
• Write and edit clinical development documents, specifically Plain Language Summaries
• Maintain timelines and workflow of writing assignments

Qualifications:

• At least 3 years of previous experience in the pharmaceutical industry
• 3-5 years of industry regulatory writing and clinical medical writing experience
• Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Clinical study protocol (CSP) and clinical study report experience (CSR) would be a plus
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines