Senior Specialist, Submission Management Clinical Trials

Bristol Myers Squibb UK

Warsaw, Poland
Base: zł144,100 - zł174,616; bonus/equity: + incen...
Hybrid (50% onsite)
3+ years regulatory submission experience
Global regulatory practices knowledge
Veeva rim system proficiency
Bristol Myers Squibb is seeking a Senior Specialist for Submission Management in Clinical Trials, based in Warsaw, Poland. The role involves managing regulatory submissions for clinical trials and engaging with stakeholders to ensure compliance with global regulatory standards

Job Summary

  • The role supports end-to-end regulatory activities by executing the preparation and compilation of compliant clinical trial maintenance submissions for global health authorities.
  • Employees will collaborate with stakeholders to define clinical trial submission strategies and manage data required for EU CTIS and substantial modifications.
  • Bristol Myers Squibb offers a wide variety of competitive benefits and programs that provide resources to pursue goals both at work and in personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Specialist for Submission Management in Clinical Trials, based in Warsaw, Poland. The role involves managing regulatory submissions for clinical trials and engaging with stakeholders to ensure compliance with global regulatory standards.

Salary

Base: zł144,100 - zł174,616; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs

Skills & Requirements

Must-have

  • 3+ years regulatory submission experience
  • Global regulatory practices knowledge
  • Veeva RIM system proficiency
  • EU CTIS substantial modifications
  • Clinical Trial Application dossier preparation

Nice-to-have

  • Artificial intelligence and automation tools
  • Stakeholder negotiation skills
  • Process innovation initiatives
  • Presentation skills for diverse audiences
  • Cross-functional team collaboration

Key Requirements

  • BA/BS degree in science or technology field
  • Minimum 3 years relevant regulatory submission experience
  • Proficiency in English written and oral communication

Work Rights

Not specified

Tailored Resume

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