Senior Medical Writer

Responsibilities

• Lead preparation, review and editing of clinical study protocols, CSRs, investigator brochures and regulatory submissions

• Collaborate with clinical research, biostatistics, regulatory affairs and medical affairs teams

• Contribute to publication plans, abstracts, posters and manuscripts

• Mentor and coach junior medical writers

Requirements

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

• Experience interpreting clinical trial data and statistical analyses

• Understanding of ICH-GCP, FDA and EMA regulatory requirements

• 3+ years medical writing experience in pharma or CRO

• Business-level English

Preferred Qualifications

• Experience interacting with regulatory agencies

Benefits

• Competitive base salary and performance incentives

• Medical, dental and vision coverage where applicable

• Retirement and pension plans

• Learning and development opportunities

About the Company

ICON is a world-class clinical research organisation delivering new medicines and medical devices to patients worldwide.