Remote Contract Medical Writer — Clinical Trials & Submissions

Evolution Research Group; United States; Remote; USD 83,000 - 138,000; Part time

Job summary

Evolution Research Group is seeking a Contract Medical Writer to support CRO-driven clinical writing in a remote US setting. The role covers drafting, editing, and coordinating documents for protocols, INDs, and final study reports, with strict adherence to GCP/ICH standards.

The ideal candidate has 5+ years of medical writing experience, strong attention to detail, and the ability to collaborate across teams while managing timelines and quality control in a fast-paced CRO environment.

Qualifications

• BS/BA in life sciences; Master’s preferred.
• Minimum 5 years of medical writing experience.
• Experience in design, execution, and analysis of clinical studies.
• CRO industry experience preferred.

Responsibilities

• Collaborate with internal and external teams across departments.
• Develop and maintain document templates for clinical trials.
• Lead study protocols and amendments.
• Provide medical writing support throughout regulatory submissions and study lifecycle.
• Ensure regulatory compliance of documentation and SOP adherence.
• Coordinate timelines and quality control across projects.
• Engage in sponsor meetings and cross-functional communication.

Skills

Organizational skills

Written and verbal communication

Attention to detail

GCP/ICH knowledge

Drug development knowledge

US regulatory guidelines

Cross-functional collaboration

MS Office proficiency

Education

BS/BA in life sciences or health-related field

Master’s degree preferred

Job description

Evolution Research Group is seeking a Contract Medical Writer to support CRO-driven clinical writing in a remote US setting. The role covers drafting, editing, and coordinating documents for protocols, INDs, and final study reports, with strict adherence to GCP/ICH standards.

The ideal candidate has 5+ years of medical writing experience, strong attention to detail, and the ability to collaborate across teams while managing timelines and quality control in a fast-paced CRO environment.