Senior Specialist, Document Management
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.
The Senior Specialist, Documentation - based in Warsaw - 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.
Duties/Responsibilities:
Independently partner with GSRD and external authors for management of eDMS processes within scope and document publishing of protocol and submission documents.
Mentor, train and provide troubleshooting assistance to GSRD personnel and external authors in the eDMS, Core Template, 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.
Qualifications
Minimum of BS/BA 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 strong 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
Please note that this position is not a remote working opportunity and is based in the local BMS office, following a hybrid work model with at least 50% onsite attendance at your assigned facility.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:
Warsaw - PL: zł144,100 - zł174,616The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.
How We Work
Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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R1601850 : Senior Specialist, Document Management