Bristol Myers Squibb is seeking a Senior Specialist in Submission Management to work in Warsaw, Poland, focusing on regulatory activities for clinical trials. The ideal candidate will have experience in regulatory submissions, strong communication skills, and a science or technology background
Job Summary
This role supports end-to-end regulatory activities for assigned projects, including preparing compliant clinical trial maintenance submissions for global health authorities.
The position requires managing data for EU CTIS, substantial modifications, and collaborating with subject matter experts to resolve information requests from health authorities.
Employees can work remotely up to 50% of the time over a two-week period and are part of a supportive environment focused on transforming patients' lives through science.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Senior Specialist in Submission Management to work in Warsaw, Poland, focusing on regulatory activities for clinical trials. The ideal candidate will have experience in regulatory submissions, strong communication skills, and a science or technology background.
Salary
Base: zł116,650 - zł141,347; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs provided
Skills & Requirements
Must-have
Global regulatory submission experience
Veeva RIM system proficiency
EU CTIS and CTA dossier preparation
Stakeholder engagement and communication
Critical thinking and problem-solving skills
Nice-to-have
Experience with artificial intelligence tools
Ability to instruct others on systems
Presentation skills for diverse audiences
Continuous improvement initiative support
Key Requirements
BA/BS degree in science or technology field preferred
Minimum 1+ years of relevant regulatory submission experience