Bristol Myers Squibb
DocumentSpecialist
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“Document Specialist at Bristol Myers Squibb. Skills: CARA structure management, submission-readiness formatting, publishing of regulatory documents, electronic document management systems, eCTD compliant regulatory documents. Facilitate CARA structure management, submission-readiness formatting and publishing of regulatory documents including clinical study reports, investigator Brochures, safety aggregate reports, and clinical protocol documents. Partner with GSRD and external authors for CARA ”
What You'll Achieve.
submission-readiness formatting; publishing of regulatory documents; CARA structure management
Industry & Context.
troubleshooting assistance
Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function for field-based and remote-by-design roles.
What They're Looking For.
Must Have
1-2 years of regulatory documentation experience in electronic document management systems, submission readiness formatting and publishing work flows, Proficiency in desktop applications, Proficiency in Acrobat and ISI toolbox usage in creation and remediation of eCTD compliant regulatory documents, Proficiency in an electronic document management system for assembly and management of regulatory documents, Understanding of document publishing processes across document types, Ability to manage timelines and quality of work using organizational, communication, facilitation, and interpersonal skills
What You'll Do.
Facilitate CARA structure management
submission-readiness formatting and publishing of regulatory documents including clinical study reports
investigator Brochures
safety aggregate reports
and clinical protocol documents
Partner with GSRD and external authors for CARA structure assembly and document publishing of protocol and submission documents
Provide guidance and troubleshooting assistance to GSRD and external authors in PRISM/CARA
submission readiness formatting and publishing work processes
Assist cross-function business partners with SRC formatting and publishing for protocol and submission related documents
Remediate externally authored Word files for submission readiness and manage PRISM import and publishing workflows
Facilitate collection and review of ICH non-data driven appendices for CSRs
Assist cross functional business partners in defining submission-ready requirements for externally authored regulatory documents
Contribute to coordination
compilation and/or authoring of select protocol and submission documents
How You'll Work.
Team & Collaboration
Partner with GSRD and external authors; Provide guidance and troubleshooting assistance to GSRD and external authors; Assist cross-function business partners; work well in a matrix team environment and with colleagues at all levels in the organization
Communication Scope
communication skills; facilitation 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** Facilitate CARA structure management, submission-readiness formatting and publishing of regulatory documents including clinical study reports, investigator Brochures, safety aggregate reports, and clinical protocol documents. **Duties/Responsibilities** * Partner with GSRD and external authors for CARA structure assembly and document publishing of protocol and submission documents. * Provide guidance and troubleshooting assistance to GSRD and external authors in PRISM/CARA, Core Template, submission readiness formatting and publishing work processes. * Assist cross-function business partners with SRC formatting and publishing for protocol and submission related documents. * Remediate externally authored Word files for submission readiness and manage PRISM import and publishing workflows. * Facilitate collection and review of ICH non-data driven appendices for CSRs. Assist cross functional business partners in defining submission-ready requirements for externally authored regulatory documents. * Contribu
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