Bristol Myers Squibb
SeniorSpecialist,DocumentManagement
“Senior Specialist, Document Management at Bristol Myers Squibb. Skills: eDMS processes, submission-readiness formatting, publishing of regulatory documents, document management. Independently manage eDMS processes within scope, submission-readiness formatting, and publishing of regulatory documents including clinical study reports, Investigator Brochures, safety aggregate reports, module 2 summaries and clinical protocol documents. Independently partner with GSRD and external authors for managem”
Industry & Context.
Demonstrated troubleshooting skills in eDMS, submission readiness formatting and document publishing work flows
What They're Looking For.
Must Have
BSA degree with approximately 2-4 years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing work flows, In-depth understanding of desktop applications, word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents, In-depth understanding of Acrobat and ISI toolbox usage in creation and remediation of eCTD compliant regulatory documents, In-depth understanding of a document management system for assembly and management of regulatory documents, Understanding of document publishing processes across document types, Demonstrated troubleshooting skills in eDMS, submission readiness formatting and document publishing work flows, Ability to manage timelines and quality of work using organizational, communication, facilitation, and interpersonal skills, Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization
What You'll Do.
Independently manage eDMS processes within scope
submission-readiness formatting
and publishing of regulatory documents including clinical study reports
Investigator Brochures
safety aggregate reports
module 2 summaries and clinical protocol documents
Independently partner with GSRD and external authors for management of eDMS processes within scope and document publishing of protocol and submission documents
train and provide troubleshooting assistance to GSRD personnel and external authors in the eDMS
submission readiness formatting and publishing work processes
Collaborate with cross-function business partners providing direction in SRC formatting and publishing of protocol and submission related documents
Lead cross functional business partners in defining submission-ready requirements for externally authored regulatory documents
Independently manage submission readiness remediation
eDMS import and publishing of externally authored PDF files
Independently manage collection and review of ICH non-data driven appendices for CSRs
Direct cross functional business partners (CTAs
Protocol Managers) in defining submission-ready requirements for ICH non-data driven appendices
Contribute to GSRD model document updates and system approval processes
Independently coordinate
compile and/or author select protocol and submission documents types ensuring integration of scientific and regulatory input from team members
Participate in continuous improvement workstreams to enhance quality and increase efficiency of document processes
including automated and digital solutions for development of regulatory documentation
How You'll Work.
Team & Collaboration
partner with GSRD and external authors; Collaborate with cross-function business partners; Lead cross functional business partners; work well in a matrix team environment and with colleagues at all levels in the organization
Communication Scope
communication skills
Process & Methodology
Ability to manage timelines and quality of work
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