Senior Scientist I/ii,, Clinical Regulatory Writing

AstraZeneca

Multiple Locations
Clinical submission strategy development
Clinical-regulatory submissions and defense
Clinical dossier delivery
Working as part of a clinical delivery team, to provide communication and writing support at the document development level for China NDA/sNDA/IND, with a good proportion of project work will involvement project management

Job Summary

  • Working as part of a clinical delivery team, to provide communication and writing support at the document development level for China NDA/sNDA/IND, with a good proportion of project work will involvement project management.
  • Function as the document lead to deliver clinical dossiers to a submission and ensure alignment of clinical submission documents with the proposed prescribing information.
  • AstraZeneca embraces diversity and equality of opportunity and is committed to building an inclusive and diverse team representing all backgrounds.

Matching Summary

Working as part of a clinical delivery team, to provide communication and writing support at the document development level for China NDA/sNDA/IND, with a good proportion of project work will involvement project management.

Skills & Requirements

Must-have

  • Clinical Submission Strategy development
  • Clinical-regulatory submissions and defense
  • Clinical dossier delivery
  • Health authority evaluation and approval
  • Cross-functional submission team member

Nice-to-have

  • Team excellence building
  • AZ best practices implementation
  • Global Med Comms consistency
  • Best practice learning and sharing
  • Proactive and resilient work style

Key Requirements

  • Minimum of two years' experience
  • Bachelor (BS/BPharm) degree in Life Sciences/Pharmacy/Pharmacology
  • Good working knowledge of clinical drug development
  • Good knowledge of regulatory guidelines

Work Rights

Not specified

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