Ardena Careers

Technical Writer

• Support the development, coordination and, where appropriate, authoring and compiling of scientific and technical documentation related to the development of synthetic and biotherapeutics
• Prepare ICH M7 Nitrosamine Risk Assessments
• Prepare Criticality Analyses
• Prepare Process Development Reports
• Prepare Investigation Reports
• Prepare other supporting documents for global regulatory submissions
• Establish and maintain project workplans
• Coordinate cross-functional Subject Matter Experts
• Track actions, dependencies and timelines and drive documentation through review and approval
• Ensure documents comply with current ICH and other applicable regulatory guidelines
• Ensure high-quality documentation and discuss potential issues with the customer

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Technical Writer – MSAT

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

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