Principal Medical Writer – Clinical Pharmacology (m/w/d)

IQVIA

Multiple Locations
Clinical pharmacology phase 1 csr writing
Protocol writing
Module 2.7.1/2.7.2 writing
Support full Clinical Study Report (CSR) writing for Phase 1, protocol development, and preparation of regulatory modules (2.7.1/2.7.2)

Job Summary

  • Support full Clinical Study Report (CSR) writing for Phase 1, protocol development, and preparation of regulatory modules (2.7.1/2.7.2).
  • Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelines.
  • Maintain central planning for document writing and QC deliverables, and provide recommendations for process improvements.

Matching Summary

Support full Clinical Study Report (CSR) writing for Phase 1, protocol development, and preparation of regulatory modules (2.7.1/2.7.2).

Skills & Requirements

Must-have

  • Clinical pharmacology Phase 1 CSR writing
  • Protocol writing
  • Module 2.7.1/2.7.2 writing
  • Health Authority responses authoring
  • Word templates and document formatting

Nice-to-have

  • Process improvement recommendations
  • Enhanced collaboration
  • Inspection-ready deliverables

Key Requirements

  • Strong experience in writing full CSR for Phase 1 clinical pharmacology studies
  • Strong experience on protocol writing
  • Strong experience on Module 2.7.1/2.7.2 (SBAAM/SCP) writing
  • Experience authoring Health Authority responses

Work Rights

Not specified

Tailored Resume

Cover Letter