Senior Associate Csr

Pfizer

In-depth knowledge of drug development process
Independent delivery of all phases csr
Great csr timeline management capability
This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting activities

Job Summary

  • This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting activities.
  • Members oversee the end-to-end lifecycle development of CSRs to support global drug registration and approval processes.
  • The role requires acting as a subject matter expert for CSR coordination business areas and authoring Standard Operating Procedures.

Matching Summary

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

Skills & Requirements

Must-have

  • In-depth knowledge of drug development process
  • Independent delivery of all phases CSR
  • Great CSR timeline management capability
  • Mastery of concurrent task management
  • Understanding of applicable filing regulatory guidelines

Nice-to-have

  • Experience of successfully mentoring others
  • Preferred skills in electronic submissions builds
  • Ability to troubleshoot technical issues efficiently
  • Fluency regarding order and presentation of regulatory dossiers

Key Requirements

  • Master's or bachelor's degree in biological, medical, pharmaceutical sciences or life sciences
  • Proficiency in English and Chinese language preferred

Work Rights

Not specified

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