Associate Csr

Pfizer

Hybrid
End-to-end csr lifecycle management
Regulatory dossier development
Quality control on csr components
This team ensures Pfizer's Clinical Study Report management meets global agency standards for regulatory reporting

Job Summary

  • This team ensures Pfizer's Clinical Study Report management meets global agency standards for regulatory reporting.
  • Members oversee the end-to-end lifecycle development of CSRs to support global drug registration and approval processes.
  • The role involves executing submission-ready quality control, coordinating with signatories, and filing reports to Trial Master Files systems.

Matching Summary

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

Skills & Requirements

Must-have

  • End-to-end CSR lifecycle management
  • Regulatory dossier development
  • Quality control on CSR components
  • Project management of approval activities
  • Trial Master Files system filing

Nice-to-have

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

Key Requirements

  • Experience in clinical study report coordination
  • Knowledge of regulatory submission requirements
  • Ability to manage document templates and mockups

Work Rights

Not specified

Tailored Resume

Cover Letter