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About the Role

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster. As a Senior Medical Writer, you will lead the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies.

Responsibilities

• Lead the preparation, review, and editing of clinical study documents, including protocols, CSRs, IBs, and regulatory submissions, ensuring accuracy, clarity, and compliance.
• Collaborate with cross-functional teams to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights.
• Participate in the planning and execution of clinical development programs, providing strategic input and scientific expertise.
• Contribute to the development of publication plans, abstracts, posters, and manuscripts for dissemination of study results.
• Mentor and coach junior medical writers, fostering a culture of excellence and continuous learning.

Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field.
• Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.
• Proficiency in interpreting and summarizing complex clinical trial data and scientific research findings.
• Excellent writing, editing, and proofreading skills.
• Ability to communicate scientific concepts to diverse audiences.
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) for clinical documents and publications.
• Experience interacting with regulatory agencies during the review and approval process.
• Demonstrated ability to work effectively in a fast-paced, deadline-driven environment.
• Ability to manage multiple projects simultaneously and prioritize tasks.
• Excellent interpersonal and communication skills.
• Ability to collaborate effectively with cross-functional teams and build relationships with stakeholders.
• University degree or equivalent in Pharmacy, Veterinary Medicine, Agriculture, Life Sciences, or related field.
• 5+ years of medical writing experience in a pharmaceutical company or CRO.
• Experience as a medical writer involved in the preparation of major regulatory submission documents.
• Sufficient knowledge of clinical development processes, including protocol design to submission, and technical issues.
• Knowledge of regulatory requirements, ICH guidelines, and pharmaceutical processes for document creation (including CTD).
• Business-level English proficiency (reading, writing, speaking) sufficient for project execution and leadership.

Skills

• Medical writing
• Clinical study document preparation
• Data interpretation
• Scientific communication
• Regulatory compliance
• Publication planning
• Mentoring
• Coaching
• Cross-functional collaboration
• Project management
• Interpersonal skills

Location

• Remote
• Tokyo
• Osaka

Work Type

• Remote
• Office

Experience Level

• Senior
• 3-5 years
• 5+ years

Education Level

• Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
• University degree or equivalent in Pharmacy, Veterinary Medicine, Agriculture, Life Sciences, or related field

Benefits

• Competitive base salary
• Performance related incentives
• Health and wellbeing programmes
• Medical coverage
• Dental coverage
• Vision coverage
• Retirement and pension plans
• Life assurance
• Disability coverage
• Employee assistance programmes
• Wellbeing resources
• Learning and development opportunities
• Structured training
• Career pathways

About the Company

• ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
• As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
• ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide.
• You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live.

Equal Opportunity

• ICON is an equal opportunity employer.
• We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.