Senior Medical Writer — Eye Health & Regulatory Submissions

IQVIA; Zaventem; On-site; EUR 70,000 - 100,000; Full time

Job summary

IQVIA is seeking an FTE Medical Writer to deliver writing services for CTRs, protocols, IBs and submission documents, with emphasis on eye health and inflammation. You will work embedded in sponsor processes, manage timelines, and contribute to cross‑functional team discussions.

The role requires about five years of medical writing experience in biopharma or CROs, strong regulatory knowledge, and excellent communication.

Qualifications

• Bachelor’s degree in a scientific/clinical/regulatory field; MSc/PhD preferred.
• Approx 5 years of medical writing experience in biopharma/CRO sectors.
• Strong knowledge of global regulatory guidelines (ICH, FDA, EMA).
• Broad understanding of clinical research processes including study design and submissions.
• Leads writing activities for complex documents with cross‑functional input.
• Excellent written and verbal communication; strong time management.

Responsibilities

• Deliver medical writing services for CTRs, TDOs/CTPs, IBs and amendments.
• Manage timelines and coordinate meetings with trial/project teams.
• Prepare and conduct RAMs, kick-off and submission meetings.
• Write drafts with appropriate in-text tables/figures per timelines.
• Coordinate reviews and integrate changes; complete QC checks.
• Publish final documents and perform pre-archive checks in EDMS.

Skills

Medical writing

Regulatory awareness

EDMS

Project management

Cross-functional collaboration

Education

Bachelor’s degree in a scientific/clinical/regulatory field

Advanced degree (MSc/PhD/PharmD/MD) preferred

Tools

Microsoft Word

eDMS systems

Document templates

Job description

IQVIA is seeking an FTE Medical Writer to deliver writing services for CTRs, protocols, IBs and submission documents, with emphasis on eye health and inflammation. You will work embedded in sponsor processes, manage timelines, and contribute to cross‑functional team discussions.

The role requires about five years of medical writing experience in biopharma or CROs, strong regulatory knowledge, and excellent communication.