Clinical Trials Medical Writer

Job Summary

Interpreting complex clinical study protocols, the full-time Clinical Trials Medical Writer will prepare and coordinate laboratory specifications and medical documents while collaborating with internal departments in a remote role based on the East Coast.

Key responsibilities

• Lead the development and maintenance of clinical study documents and amendments in compliance with SOPs and regulatory requirements
• Author and finalize global lab specification documents (GLSD) and ensure alignment with quality standards through multiple rounds of review
• Serve as a subject-matter expert for medical documentation and facilitate collaboration between stakeholders throughout the study lifecycle

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 GCP regulations
• Experience in drafting clinical trials documentation
• Proficiency in Microsoft Office and desktop publishing or word processing