Clinical Trials Medical Writer

Responsibilities

• Lead development, revision, and maintenance of complex clinical study documents and amendments per SOPs

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

• Serve as subject-matter expert for medical documentation across the study lifecycle

• Lead multiple rounds of internal and external document review

• Develop and maintain lab manuals aligned with SOPs and regulatory requirements

• Participate in client interactions during study start-up and amendments

Requirements

• BA/BS or equivalent experience in a scientific field

• 1+ years clinical trials or laboratory experience

• Working knowledge of FDA, MHRA, NYSDOH, GCP and ICH regulations

Preferred Qualifications

• Experience drafting clinical trial documentation

• Education in medical or technical writing

• Proficiency in Microsoft Office and desktop publishing

Benefits

• Pay range $77,000 - $92,000 per year

About the Company

• Integrated health services organization serving Western New York and beyond, including ACM Global Laboratories.