Clinical Trials Medical Writer

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.