Senior Medical Writer: CSR & Regulatory Modules (Phase 1)

IQVIA; Zaventem; Sur place; EUR 90 000 - 125 000; Plein temps

Résumé du poste

IQVIA is seeking a Principal Medical Writer to support full CSR writing for Phase 1 studies, protocol development, and regulatory module preparation (2.7.1/2.7.2). The role demands meticulous, inspection-ready deliverables and strong writing skills.

Responsibilities include ensuring regulatory compliance, central planning, and driving process improvements for document service teams. Excellent English communication is essential.

Qualifications

• Strong experience in writing full CSR for Phase 1 clinical pharmacology studies.
• Strong experience on protocol writing and Module 2.7.1/2.7.2 (SBAAM/SCP) writing.
• Proficient with word templates and document formatting.
• Experience authoring Health Authority responses is required.

Responsabilités

• Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelines.
• Maintain central planning for document writing and QC deliverables.
• Provide recommendations for process improvements to enhance collaboration between CPP and document service teams.
• Drive document shell creation, QC processes, and timeline management.

Connaissances

CSR writing

Protocol writing

Document formatting

Health Authority responses

English communication

Outils

Microsoft Word

Description du poste

IQVIA is seeking a Principal Medical Writer to support full CSR writing for Phase 1 studies, protocol development, and regulatory module preparation (2.7.1/2.7.2). The role demands meticulous, inspection-ready deliverables and strong writing skills.

Responsibilities include ensuring regulatory compliance, central planning, and driving process improvements for document service teams. Excellent English communication is essential.