Senior Medical Writer

Job Summary

Leading document authorship for various clinical projects, the full-time Senior Medical Writer will work remotely, interfacing directly with clients and supporting larger engagements while utilizing expertise in clinical regulatory writing.

Key responsibilities

• Manage document development for clinical regulatory submissions and related documentation
• Serve as project lead on smaller projects and collaborate with teams on larger, complex projects
• Ensure compliance with regulatory authority guidelines and anticipate impacts on final deliverables

Required qualifications

• Bachelor's degree in a relevant field
• 3+ years of experience in regulatory writing or clinical documentation
• Knowledge of regulatory authority guidelines and submission-level document development
• Experience creating clinical documents such as Clinical Study Reports and Investigator Brochures
• Intermediate proficiency in Microsoft Word and document management techniques