Lead Medical Writer (Senior Medical Writer)

About the role

ICON Strategic Solutions is hiring a Senior Medical Writer in Sao Paulo, working in a sponsor-dedicated model supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, ICON offers stability, career development and a collaborative environment. The Senior Medical Writer leads the development and execution of medical writing strategies for clinical research projects.

Key responsibilities

• Take ownership of medical writing deliverables and apply 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 wellbeing resources
• Learning and development opportunities through training and career pathways