Senior Medical Writer/Principal Medical Writer

📋 Description

• Lead development of high-quality clinical study documents on time.
• Plan, write, edit, format, and QC protocols, IBs, CSRs, DSURs.
• Ensure documents meet ICH, FDA, GCP and eCTD requirements.
• Manage document workflow with sponsor, vendors, and internal teams.
• Independently formulate key messages from study data.
• Contribute to MW processes, SOPs, templates, and work instructions.

🎯 Requirements

• BS degree or equivalent in scientific/medical field.
• 5+ years as Sr Medical Writer or 7+ years as Principal Medical Writer.
• Knowledge of ICH, FDA, GCP, EudraCT, CT.gov, and eCTD.
• Detail-oriented; ability to manage multiple high-priority projects with little guidance.
• Advanced degree (MS/PhD) preferred.
• Oncology and/or rare disease experience, esp. protocol/CSR development.