Senior Specialist, Document Management
Core
Manage eDMS processes, submission-readiness formatting, and publishing of regulatory documents including clinical study reports, Investigator Brochures, and safety aggregate reports.
Role type
Senior Specialist, Regulatory Document Management
Builds
Submission-ready regulatory documents (eCTD compliant) for clinical trials
Domain
Life Sciences / Regulatory Affairs
Required skills
eDMS management, eCTD formatting, Acrobat/ISI toolbox usage, document publishing workflows, troubleshooting, timeline management
Preferred skills
Cross-functional collaboration, continuous improvement of document processes
Technologies
eDMS, Acrobat, ISI toolbox, Word template macros
Responsibilities
Partner with GSRD and external authors for document management and publishing; Mentor and train personnel on eDMS and submission readiness; Lead cross-functional partners in defining submission-ready requirements; Manage collection and review of ICH non-data driven appendices; Coordinate and author select protocol and submission documents; Contribute to model document updates; Participate in continuous improvement workstreams for document processes
Seniority
Senior, hands-on IC