Remote Medical Writer – Clinical Trials Documentation

Lotus Clinical Research, LLC; Idaho; Remote; USD 55,000 - 110,000; Full time

Job summary

Lotus Clinical Research, LLC is seeking a Contract Medical Writer to support regulatory writing for clinical trials from a remote US-based position. The role involves authoring and editing protocols, investigator brochures, CDSR/IND submissions, and related documents with strict adherence to GCP/ICH guidelines.

The candidate will collaborate with cross-functional teams, develop templates, manage timelines, and ensure compliance with SOPs and quality standards across Phase I–IV studies; a BS/BA

Qualifications

• BS/BA in health-related or life science field.
• Master’s degree preferred.
• Minimum 5 years of medical writing experience.

Responsibilities

• Collaborate with internal and external teams on writing projects.
• Develop and maintain document templates for clinical trials.
• Lead study protocols and protocol amendments.
• Provide medical writing support for regulatory submissions.
• Ensure regulatory compliance of study documentation.
• Coordinate with vendors and manage timelines.

Skills

Organizational skills

Written communication

Verbal communication

Attention to detail

GCP/ICH knowledge

Regulatory guidelines

Clinical trial methodology

Biostatistics

Pharmacology

Interpersonal skills

MS Office

Education

BS/BA in health-related or life science

Master’s degree preferred

Tools

Microsoft Office

Job description

Lotus Clinical Research, LLC is seeking a Contract Medical Writer to support regulatory writing for clinical trials from a remote US-based position. The role involves authoring and editing protocols, investigator brochures, CDSR/IND submissions, and related documents with strict adherence to GCP/ICH guidelines.

The candidate will collaborate with cross-functional teams, develop templates, manage timelines, and ensure compliance with SOPs and quality standards across Phase I–IV studies; a BS/BA