Senior Medical Writer

Job Summary

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

Key responsibilities

• Serve as the project lead on smaller projects and support larger, complex engagements as part of a delivery team
• Develop submission-level documents and clinical documents such as Clinical Study Reports and Investigator Brochures
• Interface directly with clients to understand their needs and ensure compliance with regulatory authority guidelines

Required qualifications

• Bachelor's degree or higher in a scientific discipline strongly preferred
• 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation
• Understanding of regulatory authority guidelines and their impact on document creation
• Experience developing clinical documents, including protocols and submission-level documents
• Intermediate proficiency with Microsoft Word and document management techniques