Senior Medical Writer – Remote, Regulatory Lead

KCR Placement; Madrid; Remote; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Annual leave entitlements

Retirement planning

Global Employee Assistance Programme

Job summary

ICON Strategic Solutions seeks a Senior Medical Writer to lead medical writing strategies for clinical research projects. You will own deliverables from protocol through CSR, ensuring compliant, submission-ready documents across Phase 1–III studies.

You will analyze data, set timelines with study teams, coordinate reviews with QC and publishing specialists, and mentor junior writers to uphold a culture of scientific excellence.

Qualifications

• 3–5 years of experience as regulatory writer.
• Mandatory protocol writing experience in phase II or III; CSR experience is a plus.
• Bachelor's degree in a relevant scientific discipline or healthcare field.
• Excellent writing, editing, proofreading, and data summarization skills.
• Strong understanding of regulatory requirements (ICH-GCP, FDA, EMA) and interactions with regulatory agencies.

Responsibilities

• Own medical writing deliverables from protocol through CSR.
• Analyze data and determine best approach for each document.
• Serve as primary contact for study team on document timelines and planning.
• Coordinate document reviews with QC and publishing specialists to ensure submission readiness.
• Mentor junior writers and promote high standards of scientific writing.

Skills

Regulatory writing

Clinical writing

Documentation planning

Mentoring

Education

Bachelor's degree in a relevant field

Job description

ICON Strategic Solutions seeks a Senior Medical Writer to lead medical writing strategies for clinical research projects. You will own deliverables from protocol through CSR, ensuring compliant, submission-ready documents across Phase 1–III studies.

You will analyze data, set timelines with study teams, coordinate reviews with QC and publishing specialists, and mentor junior writers to uphold a culture of scientific excellence.