Senior Medical Writer: Clinical Trials & Regulatory Docs

IQVIA; Barcelona; On-site; EUR 50,000 - 75,000; Full time

Job summary

IQVIA is seeking a senior Medical Writer to deliver high-quality clinical documents for eye health and inflammatory indications. You will integrate with sponsor teams, manage timelines, and ensure adherence to regulatory requirements across ICH, FDA, and EMA guidelines.

The role emphasizes senior-level writing leadership, collaboration across disciplines, and adherence to sponsor SOPs while using eDMS and structured authoring tools for accurate document delivery.

Qualifications

• Bachelor's degree in a scientific, clinical, regulatory, or related field required.
• Approx 5 years of experience in medical writing within biopharma/CRO industry preferred.
• Strong knowledge of ICH, FDA, EMA guidelines across all phases of development.
• Ability to lead writing for complex documents and provide input to cross-functional teams.
• Excellent written and verbal communication with high attention to detail.

Responsibilities

• Deliver medical writing services for clinical documents including CTRs, TDOs/CTPs, IBs, and submissions.
• Embed in sponsor processes and align with project teams and timelines.
• Lead writing activities for complex documents and manage review cycles.

Skills

Regulatory knowledge

Project management

Scientific writing

Team collaboration

Attention to detail

Education

Bachelor's degree in a scientific field

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

Tools

Microsoft Word

eDMS

Structured authoring tools

Job description

IQVIA is seeking a senior Medical Writer to deliver high-quality clinical documents for eye health and inflammatory indications. You will integrate with sponsor teams, manage timelines, and ensure adherence to regulatory requirements across ICH, FDA, and EMA guidelines.

The role emphasizes senior-level writing leadership, collaboration across disciplines, and adherence to sponsor SOPs while using eDMS and structured authoring tools for accurate document delivery.