Associate Csr

Pfizer

Budapest, Hungary
Hybrid
Csr lifecycle development management
Regulatory dossier submission activities
Quality control on csr components
This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting

Job Summary

  • This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting.
  • Members oversee the end-to-end lifecycle development of CSRs to support global drug registration and approval processes.
  • The role involves coordinating compilation, quality control, approval, and post-approval processes for global CSRs.

Matching Summary

This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting.

Skills & Requirements

Must-have

  • CSR lifecycle development management
  • Regulatory dossier submission activities
  • Quality control on CSR components
  • Trial Master Files system filing

Nice-to-have

  • Process improvement suggestions
  • Continuous enhancement of practices
  • Mandarin language proficiency

Key Requirements

  • Experience in clinical study report coordination
  • Knowledge of regulatory submission requirements
  • Ability to work in a hybrid environment

Work Rights

Not specified

Tailored Resume

Cover Letter