Global Regulatory Documentation Lead

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 231,000 - 279,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Bristol Myers Squibb Co in Warsaw, Poland is seeking a Senior Manager, Global Scientific and Regulatory Documentation to lead document strategy and author critical regulatory submissions across global markets.

You will coordinate cross-functional input, manage timelines, and drive high-quality regulatory documents (IBs, CSR, protocols) while leveraging AI-enabled tools and evolving publishing processes in a hybrid work environment with significant onsite time.

Qualifications

• PharmD/PhD or Master's/Bachelor's in a relevant science field.
• 5 years of pharmaceutical regulatory documentation experience.
• Strong writing and management of regulatory documents (IB, CSR, protocols).
• Ability to analyze complex data and coordinate cross-functional input.

Responsibilities

• Authors complex regulatory documents (IBs, CSR, protocols) for global submissions.
• Lead document strategy and ensure quality and timely delivery.
• Coordinate input from cross-functional teams and manage timelines.
• Utilize document development tools and AI-enabled features to boost efficiency.

Skills

Strong writing

Cross-functional collaboration

Regulatory documentation

Timeline management

Education

PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree

5 years of pharmaceutical regulatory documentation

Job description

Bristol Myers Squibb Co in Warsaw, Poland is seeking a Senior Manager, Global Scientific and Regulatory Documentation to lead document strategy and author critical regulatory submissions across global markets.

You will coordinate cross-functional input, manage timelines, and drive high-quality regulatory documents (IBs, CSR, protocols) while leveraging AI-enabled tools and evolving publishing processes in a hybrid work environment with significant onsite time.