Medical Writer

Job Description

• Prepares scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and investigator's brochures).
• Performs literature searches and/or prepares summaries of results.
• Prepares meeting reports and proceedings, safety documents or data analysis.
• Contributes to technical proposals and responds to technical questions.

• Superior writing skills that require moderate to minimal editing.
• Knowledge of regulatory requirements for clinical studies.
• Performs core tasks with moderate to minimal supervision.
• Strong software skills to include Microsoft Office products and reference management software.
• Excellent time management and multi-tasking skills.
• Ability to analyze medical research data and review experimental protocols.
• Meets expectations with regards to work product.
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.