Clinical Trials Medical Writer (Clinical Research)

Location: Remote within the United States; Rochester, New York. Full-time, 40 hours per week, Monday–Friday daytime schedule.

Salary: $77,000–$92,000 per year.

Company

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

What you will do

• Develop, revise, maintain, and finalize complex clinical study documents and amendments in accordance with SOPs and regulatory requirements.
• Author global laboratory specification documents and lab manuals, and review documents for quality and process alignment.
• Interpret clinical study protocols and technical documentation, identify gaps, and resolve complex queries.
• Coordinate multiple rounds of internal and external document review with cross-functional stakeholders and collaborators.
• Participate in client interactions during study start-up and amendment activities.
• Apply knowledge of FDA, MHRA, NYSDOH, GCP, ICH, and other relevant regulations.

Requirements

• Bachelor’s degree or equivalent experience in a scientific field.
• At least 1 year of clinical trials or laboratory experience.
• Ability to interpret scientific and medical documentation and apply regulatory and SOP requirements.
• Strong communication, collaboration, consensus-building, and stakeholder-management skills.
• Ability to work in a sedentary role involving prolonged sitting and occasional walking or standing.

Nice to have

• Experience drafting clinical trials documentation.
• Knowledge of style guides, medical dictionaries, regulatory guidance documents, and templates.
• Education in medical or technical writing.
• Proficiency in Microsoft Office and desktop publishing or word-processing tools.

Culture & Benefits

• Remote work arrangement for applicants based in the United States.
• Collaboration across departments and lines of business.
• Opportunities for professional self-development and continued clinical-trials knowledge.
• Reasonable accommodations are considered for reported physical requirements.