Regulatory Document Specialist: eDMS & Publishing Expert

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 144,000 - 175,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Bristol Myers Squibb Co in Warsaw is seeking a Senior Specialist, Documentation to independently manage eDMS processes, formatting, and publishing of regulatory documents including CSRs and ICAs. Based in Warsaw, the role supports submission readiness and cross-functional collaboration with GSRD and external authors.

Qualifications include a BS/BA with 2–4 years in regulatory documentation, strong proficiency in Acrobat/ISI toolbox, and experience with eDMS.

Qualifications

• BS/BA degree required with 2–4 years regulatory documentation experience.
• Experience in document management repositories, submission readiness formatting and publishing workflows.
• In-depth understanding of Acrobat and ISI toolbox for eCTD documents.
• Understanding of a document management system for regulatory documents.
• Strong troubleshooting skills in eDMS and submission readiness formatting.

Responsibilities

• Manage eDMS processes and publishing of regulatory documents.
• Mentor, train and support GSRD personnel and external authors.
• Define submission-ready requirements for externally authored documents.
• Coordinate, compile and author protocol and submission documents.
• Lead continuous improvement of regulatory documentation processes.

Skills

Regulatory docs experience

eCTD formatting

eDMS troubleshooting

Acrobat

ISI toolbox

Cross-functional collaboration

Mentoring external authors

Education

BS/BA degree

Tools

Acrobat

ISI toolbox

eDMS

Job description

Bristol Myers Squibb Co in Warsaw is seeking a Senior Specialist, Documentation to independently manage eDMS processes, formatting, and publishing of regulatory documents including CSRs and ICAs. Based in Warsaw, the role supports submission readiness and cross-functional collaboration with GSRD and external authors.

Qualifications include a BS/BA with 2–4 years in regulatory documentation, strong proficiency in Acrobat/ISI toolbox, and experience with eDMS.