Job Summary

A recruiting and talent acquisition firm needs applicants for an opening for a Remote Clinical Regulatory Documents Medical Writer.

Core Responsibilities Include:

• Prepare clinical study reports (CSRs), subject narratives and clinical investigator brochures
• Prepare protocols briefing documents, clinical sections of Investigational New Drug (IND) Applications & New Drug Applications (NDAs)

Skills and Requirements Include:

• Advanced degree in life or health sciences
• AND 3+ years of medical writing experience in a pharmaceutical company
• Broad knowledge of the drug development cycle and regulatory standards
• Knowledge of current best practices and regulations regarding the documents noted above
• Keen attention to detail
• Outstanding organizational and project management skills