Lead Medical Writer for Global Clinical Trials

Remotedxb; Dubai; On-site; AED 120,000 - 180,000; Full time

Job summary

Rochester Regional Health is seeking a skilled Medical Writer to lead the development and maintenance of clinical study documents and correlate GLSDs across regulatory frameworks. The role involves interpreting protocol details and acting as a subject-matter expert for medical documentation throughout the study lifecycle.

The candidate will supervise multiple document reviews and collaborate with stakeholders to ensure high-quality outputs while staying current with FDA, GCP, and ICH guidelines.

Qualifications

• BA/BS or equivalent in a scientific field.
• 1 year clinical trials or lab experience required.
• Experience with medical writing style guides and dictionaries preferred.

Responsibilities

• Lead development, revision, and maintenance of complex clinical study and amendments per SOPs and regulatory requirements.
• Author and finalize global lab specification documents (GLSD) and related documents.
• Interpret scientific details of protocols/technical documentation.
• Serve as SME for medical documentation throughout the study lifecycle.
• Lead, initiate, and manage multiple rounds of internal and external document reviews.
• Coordinate timely collaboration between key stakeholders to ensure high-quality technical documentation.
• Maintain knowledge of FDA, MHRA, NYSDOH, GCP, and ICH regulations.

Education

BA/BS or equivalent in scientific field

Tools

Microsoft Office

Job description

Rochester Regional Health is seeking a skilled Medical Writer to lead the development and maintenance of clinical study documents and correlate GLSDs across regulatory frameworks. The role involves interpreting protocol details and acting as a subject-matter expert for medical documentation throughout the study lifecycle.

The candidate will supervise multiple document reviews and collaborate with stakeholders to ensure high-quality outputs while staying current with FDA, GCP, and ICH guidelines.