Global Regulatory & Scientific Documentation Lead

Bristol Myers Squibb EU Policy; Warszawa; Hybrid; PLN 206,000 - 249,000; Full time

Job summary

Bristol Myers Squibb EU Policy in Warsaw is seeking a Manager, Global Scientific and Regulatory Documentation to lead document strategy and author key regulatory documents in support of submissions across markets. You will coordinate cross-functional input and ensure timely, high-quality outputs.

The role involves working with AI-assisted tools, maintaining document prototypes, and managing review processes within a hybrid setup with at least 50% onsite attendance in Warsaw.

Qualifications

• Strong writing skills in authoring regulatory documents (IBs, CSR, Protocols)
• Ability to analyze complex data from diverse scientific disciplines
• Understanding global pharmaceutical drug development and regulatory processes

Responsibilities

• Coordinate and author regulatory documents for submissions, ensuring cross-functional input is integrated
• Use document development tools, AI, and structured content to improve efficiency and quality
• Manage review timelines and ensure timely completion of assigned documents
• Review and edit documents as required

Skills

Regulatory writing

Documentation management

Cross-functional collaboration

Education

PharmD/PhD or Master's/Bachelor's degree

Tools

Document management system

Job description

Bristol Myers Squibb EU Policy in Warsaw is seeking a Manager, Global Scientific and Regulatory Documentation to lead document strategy and author key regulatory documents in support of submissions across markets. You will coordinate cross-functional input and ensure timely, high-quality outputs.

The role involves working with AI-assisted tools, maintaining document prototypes, and managing review processes within a hybrid setup with at least 50% onsite attendance in Warsaw.