▪ Publish clinical trial reports (CTRs), investigator brochures, summaries, and Q&A response documents. ▪ Manage all CTRs and regulatory projects from project kick-off to approval sign-off. ▪ Prepare all documents required for regulatory submissions according to health authority guidelines, SOPs and quality standards.▪ Perform publishing and quality control tasks for ad-hoc regulatory projects.▪ Prepare literature references for inclusion in regulatory submissions.▪ Demonstrate exceptional knowledge of eCTD standards, ICH guidelines and GCP requirements. ▪ Ensure the accuracy of all CTR documents and indexing in Documentum by contributors in Trial Execution, Product Safety, and Statistics. ▪ Track and coordinate timelines for domestic and global projects.▪ Collaborate with global project teams on document quality, publishing requirements, and KPIs. ▪ Provide 1:1 and group training to stakeholders on eCTD requirements and document quality control.▪ Perform quality checks to ensure documentation is submission ready. ▪ Act as Subject Matter Expert (SME) for Documentum, providing help-desk support to internal users and 1:1 training on use of the database, document templates, and approval workflows.▪ Act as SME during SOP updates to provide perspective on impact to processes with regard to efficiency, workflow, and implementation.▪ Act as SME for poster design and compliance and manage poster projects for scientific meetings (i.e. ADA, ENDO).▪ Mitigate risks by identifying potential issues and sharing best practices. ▪ Collaborate with colleagues in Europe and Asia to standardize processes.Accomplishments:▪ Lead Publisher on projects supporting FDA and EMA NDAs for market approvals of Saxenda®, Tresiba®, Ryzodeg®, and Ozempic®.▪ Received consistent positive feedback from project stakeholders across all criteria on all post-project surveys.

▪ Ensured accuracy and tracking of source documents in Documentum.▪ Ensured all electronic documents conformed to ICH regulations and SOPs.▪ Performed all publishing tasks according to project workflow.▪ Performed quality reviews of clinical documentation for regulatory submissions. ▪ Reviewed and edited layout of manuscripts for journal submissions. ▪ Designed and edited scientific posters and slides for presentations at scientific meetings.

▪ Converted all hard copy documents for CTRs to electronic files using internal document scanning system and validation software.▪ Maintained project confidentiality and adhered to document handling protocols. ▪ Validated and uploaded site documents for study start-up in Documentum.

▪ Purchased medical supplies and equipment to support hospital operations. ▪ Managed supply inventory and budget.▪ Prepared RFP/RFQs to solicit bids for capital equipment and managed vendor contracts.▪ Improved supplier performance by requesting stakeholder feedback▪ Identified new supplier opportunities as needed.▪ Eliminated maverick spending by optimizing existing supplier relationships.▪ Audited and approved all cost center invoices across all departments. ▪ Supervised materials management staff.