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Clinical Trials Medical Writer
ACM Global Laboratories. Interpret complex clinical study protocols and medical/scientific documentation .
Posted 10/15/2026full-timeRemote • New York • United StatesJunior💰 $77,000 - $92,000 per yearWebsite
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Interpret complex clinical study protocols and medical/scientific documentation
- Prepare and coordinate laboratory specifications and study-specific medical/technical documents for ACM Global Laboratories
- Lead development, revision, and maintenance of complex clinical study documents and amendments in accordance with SOPs and regulatory requirements
- Author and finalize global lab specification documents and related documents
- Interpret scientific details, identify and resolve documentation gaps, and ensure client satisfaction
- Serve as a subject-matter expert for medical documentation throughout the study lifecycle
- Lead and manage internal and external document review rounds
- Coordinate stakeholders to ensure high-quality technical documentation aligned with business processes
- Participate in client interactions during study start-up and amendment processes
- Review GLSDs and lab manuals according to SOPs and Quality Assurance processes
- Lead development, revision, and maintenance of lab manuals
- Resolve challenges and build consensus across cross-functional groups and collaborators
- Maintain working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other relevant regulations
- Resolve complex-study queries using knowledge of regional differences and internal ACM processes
- Perform other assigned duties
Requirements
What you’ll need- 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
- Must sit on the East Coast
- Ability to work 40 hours per week, Monday–Friday days schedule