Manager, Document Management
Core
Lead end-to-end documentation workstreams for regulatory filings, health authority responses, and complex clinical protocols, ensuring submission-readiness formatting and publishing of regulatory documents.
Role type
Manager, Regulatory Document Management
Builds
eCTD compliant regulatory documents, protocol and submission documents, and ICH non-data driven appendices for Clinical Study Reports (CSRs).
Domain
Life Sciences / Regulatory Affairs / Document Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory documentation experience, eDMS process management, submission readiness formatting, PDF processing and publishing, ICH guidelines knowledge, cross-functional leadership, training and troubleshooting, timeline and quality management
Preferred skills
Desktop application macros, Acrobat and ISI toolbox usage, automated and digital solutions for document development
Technologies
eDMS, Core Template, Acrobat, ISI toolbox, Word
Responsibilities
Lead and provide strategic direction to GSRD and external authors for eDMS processes and document publishing; Lead training across GSRD for new internal and external staff; Provide strategic direction and subject matter expertise to cross-function business partners on SRC formatting; Independently manage submission readiness remediation and eDMS import of externally authored documents; Coordinate GSRD model document updates and system approval processes; Participate in continuous improvement workstreams to enhance quality and efficiency of document processes.
Seniority
Manager, strategic direction & cross-functional leadership
