Description

Researches, composes and edits clinical/statistical reports and study protocols. Summarizes data from clinical studies for submission to the Food and Drug Administration (FDA). Conducts comprehensive literature searches, documents clinical study results and product use, and ensures that all deliverables are in accordance with regulations, standards, and guidelines. 

Works with internal and external subject experts to plan, prepare, edit and finalize protocols, investigator brochures, synopses, clinical study reports regulatory documents (INDs/NDAs, annual reports, Agency Response to Questions, meeting briefing books, etc.)

Requirements

• Bachelor's degree with 5 years. Relevant career experience including, producing clinical and regulatory documents.
• Strong knowledge of FA guidelines and GCP
• Experience in coordination and prioritization of multiple projects in a fast paced environment
• Must have proven ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users
• Awareness of pharmaceutical industry needs beyond clinical development and medical affairs