Lead Medical Writer - CSR & Protocol (Phase 1)

IQVIA Argentina; Zaventem; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

IQVIA is seeking a Principal Medical Writer to support full CSR writing for Phase 1 pharmacology studies, as well as protocol development and preparation of regulatory modules 2.7.1/2.7.2. This role requires meticulous writing and hands-on experience to deliver inspection-ready documents.

You will manage document templates, coordinate QC, and collaborate with CPP and document services teams to improve processes, ensuring high-quality submissions to Health Authorities.

Qualifications

• Experience writing full CSR for Phase 1 clinical pharmacology studies.
• Experience writing Protocols and Module 2.7.1/2.7.2 (SBAAM/SCP).
• Excellent English, strong writing and formatting skills.

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.

Description du poste

IQVIA is seeking a Principal Medical Writer to support full CSR writing for Phase 1 pharmacology studies, as well as protocol development and preparation of regulatory modules 2.7.1/2.7.2. This role requires meticulous writing and hands-on experience to deliver inspection-ready documents.

You will manage document templates, coordinate QC, and collaborate with CPP and document services teams to improve processes, ensuring high-quality submissions to Health Authorities.