CMC Technical Writer

Technical Writer responsible for preparing, authoring, and finalizing CMC documentation to ensure submission-ready regulatory dossiers. Coordinates review cycles and collaborate with cross-functional teams to deliver high-quality scientific content.

• Author and edit CMC documents for regulatory submissions.
• Coordinate document review cycles and manage comment resolution.
• Ensure all documentation meets regulatory and quality standards.
• Collaborate with scientists, regulatory, and quality teams to interpret complex scientific information.
• Maintain accuracy, clarity, and consistency across all documentation.

Job Details

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