Clinical Trials Medical Writer

Rochester Regional Health
City of Rochester, NY
Category Research
Remote
Job Description
The Medical Writer is responsible for interpreting complex clinical study protocols and other medical/scientific documentation to prepare and coordinate laboratory specification and study-specific medical/technical documents for ACM Global Laboratories.

Requirements

  • Lead the development, revision, and maintenance of complex clinical study and amendments in accordance to standard operating procedures (SOPs) and regulatory requirements.
  • Serve as a subject-matter expert (SME) for medical documentation utilized throughout the study lifecycle.
  • Responsible for authoring and finalizing global lab specification documents (GLSD) and other related documents, as needed.
  • Review of low to medium complexity GLSD in accordance to SOPs and Quality Assurance processes.
  • Maintain a general working knowledge of Food & Drug Administration (FDA), Medical & Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (GCP), ICH and other pertinent regulations.
  • Perform other duties and/or tasks as assigned.
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