Clinical Trials Medical Writer

Location: Remote, must be based on the East Coast of the United States; Rochester, NY listed as the city.

Salary: $77,000–$92,000 per year

Company

hirify.global provides laboratory services and documentation support for clinical studies.

What you will do

• Develop, revise, maintain, and finalize complex clinical study documents and amendments.
• Author and review global laboratory specification documents and lab manuals.
• Interpret clinical protocols and technical documentation, identifying and resolving content gaps.
• Coordinate internal and external document reviews with cross-functional stakeholders and clients.
• Serve as a subject-matter expert for medical documentation throughout the study lifecycle.
• Apply regulatory and quality requirements to support study start-up and amendments.

Requirements

• Bachelor’s degree or equivalent experience in a scientific field.
• At least 1 year of clinical trials or laboratory experience.
• Knowledge of document preparation using style guides, medical dictionaries, regulatory guidance, and templates.
• Working knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other relevant regulations.
• Proficiency with Microsoft Office and word-processing or desktop-publishing tools.
• Must be based on the East Coast of the United States.

Nice to have

• Education in medical or technical writing.
• At least 1 year of experience drafting clinical trial documentation.
• Experience collaborating across business functions and influencing stakeholders.

Culture & Benefits

• Full-time schedule of 40 hours per week, Monday through Friday.
• Primarily sedentary, office-based work with extended computer and documentation activities.
• Accommodation is available for reported physical requirements.