Remote Associate Medical Writer

Summary

Join a leading Contract Research Organization where you will write, edit, and review Essential Documents, critically assess data from clinical studies, and collaborate with teams to develop patient safety narratives.

Requirements

• College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fields
• Minimum 2 years of corresponding industry experience working with clinical documentation and data
• Prior pharmaceutical, biotechnology, or contract research organization experience
• Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
• Basic knowledge of electronic Common Technical Document (eCTD) requirements

Responsibilities

• Writes, edits, and reviews Essential Documents
• Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
• Collects and tracks documents for CSR appendices
• Critically assesses, interprets, and summarizes data from clinical studies
• Reviews scientific literature pertinent to medical writing activities
• Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation
• Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
• Collaborates with the Process Improvement narrative automation team to develop patient safety narratives