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

Explore Technical Writer – MSAT at Ardena Careers. Review requirements and application details.