The medical writer will be responsible for authoring, editing, formatting, QC review, and/or assisting with the writing of clinical and regulatory documents, including clinical study reports, clinical summaries, clinical protocols, Investigator’s Brochures, annual safety reports, and patient safety narratives. The medical writer will provide medical writing support for medical writing activities and clinical development programs.
• Author, edit, and/or assist with the writing of clinical, regulatory, and other supporting documents for assigned studies and indications.
• Format and perform QC review of clinical and regulatory documents.
• Generate document templates and other materials to support medical writing activities.
• Maintain version control of documents, as needed.
• Work under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.