Clinical Trials Medical Writer

This is a fully remote position, open to applicants in New York.

📋 Description

• Analyze intricate clinical study protocols and medical/scientific documents.

• Create, modify, uphold, author, and finalize clinical study documents, amendments, global laboratory specifications, and lab manuals.

• Detect and address documentation deficiencies and complex study inquiries.

• Act as a subject-matter expert in medical documentation throughout the study lifecycle.

• Oversee and manage internal and external document review cycles.

• Facilitate collaboration among stakeholders and cross-functional teams.

• Engage in client interactions during the study initiation and amendment phases.

• Evaluate GLSDs and lab manuals in accordance with SOPs and Quality Assurance procedures.

• Sustain a comprehensive understanding of relevant clinical trial regulations.

• Commit to professional self-improvement and undertake other assigned tasks.

⛳️ Requirements

• BA/BS degree or equivalent experience in a scientific discipline.

• Minimum of 1 year experience in clinical trials or laboratory settings is required.

• Practical knowledge of standard document content preparation, including style guides, medical dictionaries, regulatory guidance documents, and templates.

• Competency in Microsoft Office along with desktop publishing or word processing skills.

• Background in medical or technical writing.

• Over 1 year of experience in drafting clinical trial documentation.

• Familiarity with FDA, MHRA, NYSDOH, GCP, ICH, and other applicable regulations.

• Availability to work Monday through Friday, 40 hours per week.

• Must reside on the East Coast.

• Capability to perform sedentary, primarily office-based tasks with extended periods of sitting.

• Fine motor skills necessary for computer tasks, writing, and telephone communication.

• Clear visual and auditory capabilities.

• Flexible hours, TB screening, or a valid driver’s license may be required for certain roles.

🏝️ Benefits

• Eligibility for additional compensation components.

• Possible accommodations for reported physical requirements.

• Equal Opportunity Employer.