Content Writer

• Write and compile scientific and technical documents related to drug substance development for new chemical entities and biological products
• Prepare synthesis criticality assessments, starting material justification reports, impurity management reports, and documents related to upscaling of synthesis processes
• Prepare documents used as the basis for global regulatory submissions, including clinical trial applications and marketing applications
• Establish the control strategy for drug substance manufacturing, including specifications
• Conduct nitrosamine and mutagenicity assessments per ICH M7
• Align documents to ensure compliance with the latest ICH guidelines
• Manage and coordinate technical writing and reviewing activities
• Collaborate with experienced colleagues and other Ardena teams to provide CMC advice throughout drug development and dossier submission

Explore CMC Writer at Ardena Careers. Review requirements and application details.