Clinical Trials Medical Writer

Rochester Regional Health

. Interpret complex clinical study protocols and medical/scientific documentation .

Posted 10/15/2026full-timeRemote • New York • United StatesJunior💰 $77,000 - $92,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical study documentation, including the development and revision of clinical study documents and adherence to regulatory standards. Proficient in coordinating stakeholder collaboration and managing document review processes throughout the study lifecycle.

Highest-signal resume keywords

Clinical Trials DocumentationRegulatory Knowledge (FDA, MHRA, GCP, ICH)Microsoft Office ProficiencyMedical Writing EducationDocument Content Preparation

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Study Protocol InterpretationDocument Revision and MaintenanceDocumentation Gap ResolutionGlobal Lab Specification Document ReviewSOP ComplianceTechnical WritingLaboratory ExperienceDocument Style Guide ApplicationQuality Assurance ProcessesFine Motor Skills

Soft Skills

CollaborationCommunicationProblem-SolvingAttention to DetailFlexibility

Tools & Technologies

Desktop Publishing SoftwareWord Processing Software

Industry Keywords

Clinical TrialsMedical DocumentationStudy LifecycleStakeholder CoordinationRegulatory Guidance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Interpret complex clinical study protocols and medical/scientific documentation
Develop, revise, maintain, author, and finalize clinical study documents, amendments, global lab specification documents, and lab manuals
Identify and resolve documentation gaps and complex study queries
Serve as a subject-matter expert for medical documentation throughout the study lifecycle
Lead and manage internal and external document review rounds
Coordinate collaboration among stakeholders and cross-functional groups
Participate in client interactions during study start-up and amendment processes
Review GLSDs and lab manuals according to SOPs and Quality Assurance processes
Maintain working knowledge of applicable clinical-trial regulations
Pursue professional self-development and perform other assigned duties

Requirements

What you’ll need

BA/BS, or equivalent experience in scientific field
1 year of clinical trials or other laboratory experience required
Applied knowledge of routine document content preparation, including 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
1+ years’ experience drafting clinical trials documentation
Working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other pertinent regulations
Ability to work Monday–Friday, 40 hours per week
Must sit on the East Coast
Ability to perform sedentary, primarily office-based work with prolonged sitting
Fine motor skills for computer work, writing, and telephone use
Clear visual and auditory ability
Flexible hours, TB screening, or a valid driver’s license may be required for some roles

Benefits

Comp & perks

Eligible for additional pay components
Potential accommodations for reported physical requirements
Equal Opportunity Employer