Manager, Document Management

Biopharma Careers; Warszawa; On-site; PLN 175,000 - 212,000; Full time

Benefits offered by this job

Hybrid work model

On-site Warsaw facility

Job summary

Bristol Myers Squibb in Warsaw is seeking a Manager, Document Management to lead end-to-end documentation workstreams for regulatory filings, HA responses and complex clinical protocols, including eDMS strategies, submission readiness formatting, and publishing across document types.

The role requires 4+ years in regulatory documentation, expertise in Acrobat/ISI toolbox, and strong cross-functional leadership. Hybrid work with 50% onsite attendance is required at the Warsaw facility.

Qualifications

• BS/BA degree required with 4+ years regulatory documentation experience.
• Expertise in desktop applications and word template macros for eCTD submissions.
• Proficient in Acrobat and ISI toolbox for complex PDFs and eCTD compliance.
• Experience with eDMS, submission readiness formatting and document publishing workflows.
• Strong training and troubleshooting skills for eDMS and document publishing workflows.

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.

Skills

Regulatory documentation

eDMS

PDF publishing

Cross-functional collaboration

Training

Project management

Education

BS/BA degree with 4+ years regulatory documentation experience

Tools

Acrobat

ISI toolbox

Document management system

PDF remediation

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 .

The Manager, Document Management - based in Warsaw - leads 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

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.

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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far the importance of our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by 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 these roles, onsite presence is considered an essential job function 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 workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, direct your inquiries to [e-mail] . 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

R1601853 : Manager, Document Management