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ICON plc

Lead Medical Writer

ICON plc

. Lead the development and execution of medical writing strategies for clinical research projects .

Posted 9/22/2026full-timeRemote • Brazil, MexicoSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in medical writing strategies, including the preparation and review of clinical documents and regulatory submissions. Proficient in interpreting clinical trial data and collaborating with cross-functional teams to ensure compliance with regulatory standards.

Highest-signal resume keywords
Medical Writing Strategy DevelopmentClinical Study Protocol PreparationRegulatory Submission ExpertiseStatistical Data InterpretationMentoring Junior Medical Writers

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Clinical Study Report WritingEditing and ProofreadingRegulatory Requirements KnowledgeICH-GCP ComplianceFDA Submission ProcessesEMA Guidelines UnderstandingStatistical Analysis InterpretationPublication PlanningScientific Manuscript DevelopmentClinical Trial Data Summarization
Soft Skills
Interpersonal CommunicationCollaborationProject ManagementInfluencing Decision-MakingCoaching and Mentoring
Industry Keywords
Clinical ResearchRegulatory AffairsBiostatisticsMedical AffairsHealthcare-related Field

About the role

Key responsibilities & impact
  • Lead the development and execution of medical writing strategies for clinical research projects
  • Own medical writing deliverables and apply expertise to complex challenges
  • Lead the preparation, review, and editing of clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions
  • Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams to interpret clinical trial data and summarize scientific findings
  • Participate in planning and execution of clinical development programs
  • Provide strategic input and scientific expertise for the design, conduct, and interpretation of clinical studies and research initiatives
  • Contribute to 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
  • Foster excellence, collaboration, and continuous learning within the medical writing team

Requirements

What you’ll need
  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
  • Excellent writing, editing, and proofreading skills
  • Strong understanding of regulatory requirements, including ICH-GCP, FDA, and EMA, governing the preparation and submission of clinical documents and publications
  • Experience interacting with regulatory agencies during the review and approval process
  • Ability to work effectively in a fast-paced, deadline-driven environment
  • Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables
  • Excellent interpersonal and communication skills
  • Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes
  • Legal right to work in the country where the role is based

Benefits

Comp & perks
  • 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 structured training and career pathways