Senior Specialist, Document Management
Core
Manage eDMS processes, submission-readiness formatting, and publishing of regulatory documents including clinical study reports and protocols for pharmaceutical submissions.
Role type
Senior Specialist, Regulatory Document Management
Builds
eCTD compliant regulatory documents and submission packages
Domain
Pharmaceutical / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
eDMS management, submission readiness formatting, ICH non-data driven appendices, Acrobat usage, ISI toolbox, word template macros, document assembly, timeline management, quality assurance
Preferred skills
mentoring, cross-functional collaboration, continuous improvement, automated/digital solutions
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 workflows; Lead cross-functional partners in defining submission-ready requirements; Coordinate and author select protocol and submission documents; Contribute to model document updates and system approval processes; Participate in continuous improvement workstreams for document processes
Seniority
Senior, hands-on IC
