Report/RA Submission Publisher
- Produces paper/electronic regulatory submissions (e.g., Clinical Study Reports, INDs, NDAs, MAAs, annual reports, routine submissions) in accordance with U.S. FDA and global requirements, using electronic publishing tools (Insight Publisher) and an EDMS system.
- Interacts with the Medical Writing Department and with other functions to ensure publishing timelines are met.
- Provides expertise on publishing and authoring activities.
- Assists the Manager of Regulatory Submissions and Clinical Report Publishing Lead with projects as required.
Regulatory publishing responsibilities:
- Publishes routine submissions prepared by RA Managers.
- Conducts quality reviews and revises submissions.
- Publishes Clinical Study Reports, annual reports, and INDs/NDAs/MAAs or portions thereof for assigned projects.
Requires knowledge of FDA/EMEA regulations and guidance for electronic and paper submissions and an understanding of the Clinical Study Report Requirements (ICH E3)
Working knowledge of Liquent Insight Publisher, Liquent eCTD Reviewer with Conformity Checker, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox is preferred.
Strong computer skills with demonstrated experience and ability in Documentum, Microsoft Office suite (Word, Excel, Access, and PowerPoint)