Lead Medical Writer

About the role

ICON Strategic Solutions is hiring a Lead Medical Writer in Sao Paulo, working in a sponsor-dedicated model supported by ICON's global expertise. As a Senior Medical Writer, you will lead the development and execution of medical writing strategies for clinical research projects, helping advance treatments that benefit patients worldwide.

Key responsibilities

• Take ownership of medical writing deliverables and apply your expertise to complex challenges.
• Lead the preparation, review and editing of clinical study documents such as protocols, clinical study reports (CSRs), investigator brochures (IBs) and regulatory submissions, ensuring accuracy and clarity.
• Work with clinical research, biostatistics, regulatory affairs and medical affairs teams to interpret and analyse clinical trial data and summarise scientific findings.
• Contribute to the planning and execution of clinical development programmes, giving strategic input on the design, conduct and interpretation of clinical studies.
• Help develop publication plans, abstracts, posters and manuscripts for peer-reviewed journals and scientific conferences.
• Mentor and coach junior medical writers on best practices, writing techniques and scientific principles.

Required profile

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Strong foundation in medical writing, with the experience to work independently and guide others.
• Ability to work in a fast-paced, deadline-driven environment and manage multiple projects at once.
• Excellent interpersonal and communication skills and the ability to influence decision-making with cross-functional teams.
• Legal right to work in the country where the role is based.

Required skills

• Interpreting and summarising complex clinical trial data, research findings and statistical analyses.
• Writing, editing and proofreading.
• Understanding of regulatory requirements such as ICH-GCP, FDA and EMA, and experience interacting with regulatory agencies.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and learning and development opportunities.