Senior Medical Writing Manager
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
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
