Senior Specialist, 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.

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 the position is not a remote working opportunity and is based in the local BMS office.

Compensation Overview

Warsaw - PL: zł144,100 - zł174,616

The 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.

On‑site Protocol

Site‑essential roles require 100% of shifts onsite at their assigned facility. Site‑by‑design roles may be eligible for a hybrid work model with at least 50% onsite at the assigned facility. On‑site presence is considered an essential job function for these roles and is critical to collaboration, innovation, productivity, and a positive company culture.

For field‑based and remote‑by‑design roles the 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.

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 accommodation prior to accepting a job offer. BMS provides a complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in the applicant’s area.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.