Clinical Trials Medical Writer

Job Summary

Interpreting complex clinical study protocols, the full-time Clinical Trials Medical Writer will develop, revise, and finalize laboratory specifications and medical documents while collaborating with internal departments in a remote work environment.

Key responsibilities

• Lead the development and maintenance of clinical study documents in compliance with SOPs and regulatory requirements
• Serve as a subject-matter expert for medical documentation throughout the study lifecycle, ensuring quality and alignment with business processes
• Manage multiple rounds of document review and facilitate collaboration among key stakeholders to meet project timelines

Required qualifications

• BA/BS or equivalent experience in a scientific field
• 1 year of clinical trials or laboratory experience required
• Knowledge of FDA, MHRA, and other regulatory requirements related to clinical trials
• Experience with document content preparation and familiarity with style guides and regulatory guidance documents
• Proficiency in Microsoft Office and desktop publishing or word processing tools