Senior Medical Writer

Responsibilities

• Independently produce clinical and regulatory documents such as Clinical Study Protocols and Clinical Study Reports

• Analyze and interpret clinical trial data to determine document approach

• Act as primary contact for the study team on document preparation and timelines

• Facilitate document review to ensure submission-ready, approved deliverables

• Mentor and coach junior medical writers

Requirements

• 3-5 years of experience as a regulatory writer

• Mandatory protocol writing experience in Phase II or III studies

• Bachelor's degree in a relevant scientific or healthcare field

• Strong understanding of ICH-GCP, FDA and EMA requirements

• Excellent writing, editing and proofreading skills

• Strong interpersonal and cross-functional communication skills

Preferred Qualifications

• CSR writing experience

Benefits

• Competitive base salary and performance-related incentives

• Medical, dental and vision coverage where applicable

• Retirement and pension plans

• Life assurance and disability coverage

• Learning and development opportunities

About the Company

• ICON is a world-class clinical research organisation and the largest FSP organisation, with over 90 sponsor partnerships.