Manager, Document Management

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 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.

Qualifications

• Minimum of BS/BA 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 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.

Compensation Overview

Warsaw - PL zł174,980 - zł212,026. 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.

Work Location

Remote: Not a remote working opportunity – position is based in the local BMS office. On-site Protocol: BMS has an occupancy structure that determines where an employee is required to conduct their work. This includes site-essential, site-by-design, field-based, and remote-by-design jobs.

The occupancy type assigned depends on the nature and responsibilities of your role. Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For field-based and remote-by-design roles the ability to travel to visit customers, patients or business partners and attend meetings on behalf of BMS is essential.

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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Job Information

R1601853 Manager, Document Management

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