- Expedite, manage and coordinate a multitude of interrelated activities for a submission team in the development of published submissions within the required timelines. Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely dispatch (by agency gateway; CD/DVD/paper; SharePoint upload) and archival of regulatory submissions, and effective maintenance of supporting documentation (e.g. email, planners, QC documentation)eCTDXpress experience a plus
- Support Regulatory processes and systems in the publication and submission of a New Drug Application (NDA) planned for August 2020.
- Provide support for the pre-publishing and post-publishing phases of Regulatory submission production and distribution, specifically tasks associated with submission QA and QC
- To help coordinate the work performed by and collaborate with other publishers to enable them to complete the necessary tasks.Hyperlinking, bookmarking, PDF tasks such as orientation, assigning proper metadata, rendering as required by FDA eCTD Guidance
XML Backbone build and other submission related tasks
Perform detailed quality reviews of published output as requested to ensure compliance with relevant Regulatory Standards and Agency guidance.
- Track metrics associated with submission publishing and rework.
- 5+ years of submission experience
- Essential to work accurately and pay close attention to detail
- Quick to learn new IT systems and processes and the ability to thrive in a changing environment and to re-prioritize workload to meet business needs
- Good communication skills, both verbal and written
- Educated to degree level or equivalent experience
- Experience of working in a regulatory submissions or registration management environment
- Experience with publishing-related software tools including Documentum, Adobe Acrobat, TRS (ISI) Toolbox, XML and Microsoft Office, Sharepoint, Veeva and eCTDXpress
- Effective planning and organizational skills and time management.