Global Regulatory Docs & Content Strategy Leader

Bristol Myers Squibb; Warszawa; On-site; PLN 542,000 - 657,000; Full time

Job summary

Bristol Myers Squibb in Warsaw seeks a Director, Global Scientific and Regulatory Documentation, Content Strategy to lead a team of scientific writers across therapeutic areas and guide assignments. You will drive process improvements, mentor staff, and ensure high-quality regulatory documentation for global submissions.

You will apply GenAI to optimize workflows, influence regulatory strategies, and collaborate with multiple functions to ensure compliant, timely deliverables in a dynamic,

Qualifications

• PharmD/PhD/MD in a relevant scientific discipline or Master’s/Bachelor’s degree with a minimum of 10 years in pharmaceutical regulatory documentation.
• Proven record in managing group/project teams with cross-functional collaboration and communication.
• Significant experience in writing high-quality regulatory documentation, including high-level summary documents (clinical).
• Experience in managing project teams and process workflows with cross-functional collaboration and communication.
• Experience in rapidly changing environments where decisiveness, adaptability, and communication are critical.

Responsibilities

• Work with Therapeutic Area Lead to optimize delivery of content and documentation for the BMS pipeline.
• Assess resource requirements for all projects and allocate resources per R&D priorities; select external documentation support when needed.
• Review regulatory, clinical, and safety documentation per good documentation principles and regulatory standards.
• Recruit and train scientific writers; set performance standards and provide coaching and evaluation input.
• Lead innovation projects applying GenAI to automate and optimize regulatory writing processes.

Skills

Regulatory leadership

Cross-functional collaboration

Mentoring

GenAI in writing

Process improvement

Project management

Education

PharmD/PhD/MD in relevant scientific discipline

Master's/Bachelor's degree in related field

10+ years in regulatory documentation

Tools

GenAI

Job description

Bristol Myers Squibb in Warsaw seeks a Director, Global Scientific and Regulatory Documentation, Content Strategy to lead a team of scientific writers across therapeutic areas and guide assignments. You will drive process improvements, mentor staff, and ensure high-quality regulatory documentation for global submissions.

You will apply GenAI to optimize workflows, influence regulatory strategies, and collaborate with multiple functions to ensure compliant, timely deliverables in a dynamic,