Clinical Document Specialist, cFSP
Location
Mexico City, Mexico
Job Type
Full-time
Category
other-general
Posted
June 17, 2026
The **Clinical Study Report (CSR) Document Specialists** is responsible to populate, track, QC and perform technical editorial checks of the CSR appendices for assigned studies, from authoring until document finalization in the DMS in compliance with current Novartis processes, ICH-GCP, and relevant regulatory requirements.
**CSR Document specialists** responsibilities include, but are not limited to:
+ Lead the CSR appendices kick off meeting and define the timelines together with the CSR sub team
+ Plan and prioritize the appendices for publishing activities
+ Coordinate with the TMF manager/Study Lead as applicable, to ensure completion/availability of all essential documents for the CSR appendices are in the TMF
+ Manage the CSR appendix related activities: create and populate CSR appendix based on templates in the DMS including support for the publishing of appendices
+ Coordinate and track the line functions review of the draft CSR appendices<...
**CSR Document specialists** responsibilities include, but are not limited to:
+ Lead the CSR appendices kick off meeting and define the timelines together with the CSR sub team
+ Plan and prioritize the appendices for publishing activities
+ Coordinate with the TMF manager/Study Lead as applicable, to ensure completion/availability of all essential documents for the CSR appendices are in the TMF
+ Manage the CSR appendix related activities: create and populate CSR appendix based on templates in the DMS including support for the publishing of appendices
+ Coordinate and track the line functions review of the draft CSR appendices<...