Clinical Trials Medical Writer

Role Overview

• Interpret complex clinical study protocols and other medical/scientific documentation
• Prepare and coordinate laboratory specification and study-specific medical/technical documents
• Partner with internal departments in document development, drafting, review, editing, and finalization
• Manage multiple rounds of internal and external document review
• Serve as a subject-matter expert (SME) for medical documentation
• Participate in client interactions during study start-up activities
• Maintain knowledge of FDA, MHRA, NYSDOH regulations
• Resolve challenges and build consensus among cross-functional groups and collaborators

Requirements

• BA/BS, or equivalent experience in scientific field
• 1 yrs clinical trials or other laboratory experience required
• Applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, regulatory guidance documents, and templates
• Proficient in Microsoft Office and desktop publishing or word processing
• Education in medical or technical writing
• Excellent communication skills
• Ability to effectively influence others, work in a team environment, and collaborate across lines of business and functions
• 1+ years’ experience drafting clinical trials documentation

Benefits

• Health insurance
• 401(k) matching
• Paid time off
• Remote work options
• Professional development opportunities