Senior Associate Csr

Pfizer

In-depth knowledge of drug development process
Independent delivery of all phases csr
Mastery of concurrent task management
This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting and dossier development

Job Summary

  • This team ensures Pfizer's Clinical Study Report management meets global agency standards and manages regulatory reporting and dossier development.
  • Members oversee the end-to-end lifecycle development of CSRs to support global drug registration, including submission, publishing, and archiving.
  • The role requires acting as a subject matter expert for CSR coordination while leading moderately complex projects and providing mentorship.

Matching Summary

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

Skills & Requirements

Must-have

  • In-depth knowledge of drug development process
  • Independent delivery of all phases CSR
  • Mastery of concurrent task management
  • Understanding of applicable filing regulatory guidelines
  • Fluency regarding order and presentation of regulatory dossiers

Nice-to-have

  • Experience successfully mentoring others
  • Preferred skills in electronic submissions builds
  • Ability to troubleshoot technical issues independently
  • Customer service environment experience
  • Process improvement suggestions capability

Key Requirements

  • Master's or bachelor's degree in biological, medical, pharmaceutical sciences or life sciences
  • Proficiency in English and Chinese language preferred
  • Experience working in a highly regulated environment

Work Rights

Not specified

Tailored Resume

Cover Letter