Ardea is seeking a full-time, senior-level medical writer who will be responsible for writing regulatory documents in support of drug development, as well as assisting with the oversight of writing projects assigned to contractors and CROs. This individual will responsible for writing and overseeing the production of regulatory documents in support of drug development programs, including protocols, study reports, investigator brochures, and summary documents.
For more Information on Job Responsibilities and Requirements - Interested parties please apply today at: www.ardeabio.com/careers
• Write and/or update clinical protocols, clinical study reports, Investigator Brochures, safety narratives, IND annual updates, and other clinical regulatory documents in accordance with predefined, aggressive timelines.
• Write and/or update nonclinical documents and summaries as well as regulatory submission components from other disciplines, as needed.
• Assist the department head in overseeing projects assigned to contractors and CROs, including timeline development and management.
• Evaluate draft documents and draft statistical output for accuracy and consistency.
• Represent department and provide status updates at internal meetings and meetings with external collaborators.
• Support the timely generation of high-quality regulatory documentation by assuming other duties, including document editing, QC, and formatting.