Global Regulatory Documentation & Content Strategy Lead

Biopharma Careers; Warszawa; Hybrid; PLN 542,000 - 657,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland seeks a Director, Global Scientific and Regulatory Documentation, Content Strategy to lead regulatory writing teams across therapeutic areas and align with R&D priorities.

You will mentor writers, implement process improvements, champion GenAI applications, and collaborate across functions to ensure high-quality dossiers and efficient workflows. This role supports hybrid work with a strategic focus on global regulatory submissions.

Qualifications

• Experience in regulatory documentation leadership for drug submissions.
• Strong cross-functional collaboration and communication skills.
• Ability to mentor and develop writers and manage projects.

Responsibilities

• Coordinate with Therapeutic Area Lead to optimize content delivery and documentation supporting the pipeline.
• Assess project resource needs and allocate external resources when needed.
• Review regulatory, clinical, and safety documentation for standards and compliance.
• Recruit, train, and evaluate scientific writers; set performance standards.

Skills

Regulatory writing

Leadership

Cross-functional collaboration

Regulatory strategy

Education

PharmD/PhD/MD or Masters/Bachelors

Job description

Bristol Myers Squibb in Warsaw, Poland seeks a Director, Global Scientific and Regulatory Documentation, Content Strategy to lead regulatory writing teams across therapeutic areas and align with R&D priorities.

You will mentor writers, implement process improvements, champion GenAI applications, and collaborate across functions to ensure high-quality dossiers and efficient workflows. This role supports hybrid work with a strategic focus on global regulatory submissions.