Scientific Medical Writer (m/w/d)

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

• We are seeking a Principal Medical Writer to support full Clinical Study Report (CSR) writing for Phase 1 , protocol development, and preparation of regulatory modules (2.7.1/2.7.2) . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables.


• Key Responsibilities:


• 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

• We are seeking a Principal Medical Writer to support full Clinical Study Report (CSR) writing for Phase 1 , protocol development, and preparation of regulatory modules (2.7.1/2.7.2) . This role requires strong writing skills and attention to detail to ensure high-quality, inspection-ready deliverables.


• Key Responsibilities:


• 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

Skills & Experience

• 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.


• Proficient in Word templates and document formatting


• Excellent communication skills (oral and written) in English

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.