Bristol Myers Squibb
Manager,DocumentManagement
Neural analysis suggests this role is
optimal for Mid candidates.
“Manager, Document Management at Bristol Myers Squibb. Skills: document management, submission readiness formatting, publishing work flows, eDMS processes, PDF processing, regulatory documents. Lead end-to-end documentation specialist’s workstreams for regulatory filings, HA response or complex clinical protocols including strategies for eDMS processes within scope, submission-readiness formatting, PDF processing and publishing of regulatory documents across protocol and submission document types”
What You'll Achieve.
submission-readiness formatting; PDF processing; publishing of regulatory documents; driving submissions and approvals; submission readiness remediation; enhance quality and increase efficiency of document processes
Industry & Context.
troubleshooting assistance
What They're Looking For.
Must Have
Minimum of BSA degree with 4+ years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing work flows., Subject matter expertise in desktop applications, word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents., Subject matter expertise in Acrobat and ISI toolbox usage for creation of complex PDF compilation and remediation of PDF documents for eCTD compliance., Subject matter expertise in the document management system for assembly and management of complex regulatory documents., Deep understanding of document publishing processes across GSRD document types, Demonstrated training and 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.
Lead end-to-end documentation specialist’s workstreams for regulatory filings
HA response or complex clinical protocols including strategies for eDMS processes within scope
submission-readiness formatting
PDF processing and publishing of regulatory documents across protocol and submission document types.
Lead and provide strategic direction to GSRD and external authors for eDMS processes within scope and document publishing of protocol and submission documents.
Lead and provide strategic direction on documentation specialist workstream for all submission level documents including model 2 summaries and HA submission driving submissions and approvals.
Lead training across GSRD for new internal and external staff.
Provide troubleshooting assistance to GSRD personnel and external authors in the eDMS
submission readiness formatting and publishing work.
Provide strategic direction and subject matter expertise to cross-function business partners on 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 Word and 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.
Provide strategic direction and coordinate GSRD model document updates and system approval processes.
Provide strategic direction and 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
work well in a matrix team environment and with colleagues at all levels in the organization; cross-functional coordination; cross-function business partners; external authors; GSRD personnel
Communication Scope
communication skills
Process & Methodology
Ability to manage timelines and quality of work
Full Job Description
**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). **Position Summary** Lead end-to-end documentation specialist’s workstreams for regulatory filings, HA response or complex clinical protocols including strategies for eDMS processes within scope, submission-readiness formatting, PDF processing and publishing of regulatory documents across protocol and submission document types. **Responsibilities** * Lead and provide strategic direction to GSRD and external authors for eDMS processes within scope and document publishing of protocol and submission documents. * Lead and provide strategic direction on documentation specialist workstream for all submission level documents including model 2 summaries and HA submission driving submissions and approvals. * Lead training across GSRD for new internal and external staff. Provide troubleshooting assistance to GSRD personnel and external authors in the eDMS, Core Template, submission readiness formatting and publishing work * Provide strategic direction and subject matter expertise to cross-function business partners on SRC formatting
Applying for this Manager, Document Management role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Bristol Myers Squibb?
Real rants from real employees. Read before you apply.