Principal Medical Writer

Responsibilities

• Lead preparation and review of clinical study reports, protocols and regulatory documents

• Collaborate with clinical research, biostatistics and regulatory affairs teams

• Provide guidance on medical writing best practices and regulatory requirements

• Mentor and train junior medical writers

• Lead clinical and regulatory marketing approval applications for biologics and drugs

Requirements

• Bachelor's degree in life sciences, pharmacy or related discipline

• Significant medical writing experience in regulatory submissions and clinical documentation

• Strong understanding of regulatory requirements and clinical writing standards

• Exceptional writing and editing skills

• Excellent communication and interpersonal skills

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.