Senior Medical Writing Manager

Job Summary

A company is looking for a Senior Medical Writing Manager to support oncology drug development through high-quality clinical documentation.

Key Responsibilities

• Lead the drafting and editing of critical documents such as protocols, investigator's brochures, and clinical study reports
• Contribute to Health Authority briefing documents and regulatory submissions
• Drive collaboration with cross-functional teams to manage timelines and facilitate document reviews

Required Qualifications

• BA/BS degree in life sciences and at least 7 years of medical or scientific writing experience in the pharmaceutical industry
• Experience authoring protocols, investigator's brochures, and clinical study reports
• Knowledge of Health Authority briefing packages and regulatory submissions is preferred
• Solid understanding of clinical development and regulatory frameworks, including GCP and ICH guidelines
• Proficiency with writing tools such as MS Word and document management systems