The Publishing Associate II, Regulatory Submissions Management, is responsible for responsible for the publishing and dispatch of major and complex lifecycle management eCTD submissions and ensuring technical validation. They have proficient knowledge of internal/external publishing standards, electronic publishing/viewing software tools and document management systems. Independently performs document level publishing activities, troubleshoots document issues and performs quality control checks for submission ready documents. Trains junior staff on processes, standards and tools and delegates publishing tasks.
1. Publish and dispatch major and complex routine/lifecycle management eCTD submission
2. Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
3. Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
4. Leads and participates in Global Regulatory Affairs project teams
5. Trains junior staff on processes and tools
Significant and relevant work experience may be substituted for Bachelor’s degree.