Clinical Trials Medical Writer

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

Responsibilities

• Lead the development, revision, and maintenance of complex clinical study and amendments in accordance to SOPs and regulatory requirements


• Author and finalize global lab specification documents (GLSD) and other related documents


• Interpret and contribute to the scientific details of the protocol/technical documentation


• Serve as a subject-matter expert (SME) for medical documentation utilized throughout the study lifecycle


• Lead, initiate, and manage multiple rounds of internal and external document review


• Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meets high quality standards


• Maintain a general working knowledge of FDA, MHRA, NYSDOH, GCP, and ICH regulations

Requirements

• BA/BS, or equivalent experience in scientific field


• 1 year clinical trials or other laboratory experience required

Preferred Qualifications

• Applied knowledge of routine document content preparation using style guides and medical dictionaries


• Proficient in Microsoft Office and desktop publishing


• Education in medical or technical writing


• 1+ years experience drafting clinical trials documentation

About the Company

Rochester Regional Health is an integrated health services organization serving Western New York and beyond, including ACM Global Laboratories, a global leader in patient and clinical trials.