Senior Medical Writer

🔥 1 minute ago

🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead the development and execution of medical writing strategies for clinical research projects • Own medical writing deliverables and apply expertise to complex challenges • Prepare, review, and edit clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), 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 executing clinical development programs • Provide strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives • Develop publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences • Mentor and coach junior medical writers • 治験実施計画書の作成 • 治験総括報告書の作成 • 医薬品の承認申請資料（CTD：コモンテクニカルドキュメント）の作成（非臨床または臨床パート） • 治験薬概要書の作成 • 上記作成ドキュメントのレビュー • 当局対応（臨床パートのドキュメント作成、レビューまたはコンサルティング等） • 規制要件を満たす文書作成全般のコンサルティング • 経験の浅いメンバーへの適切な指導、及びメンバーの成長への貢献

🎯 Requirements

• 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 (e.g., ICH-GCP, FDA, EMA) • Experience in 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 • 大学卒以上（医薬、獣医、農学、生命科学等の学部学科）、または同等の学位保有者 • 製薬会社、またはCROにおける3年以上のメディカルライティング業務の経験 • ビジネスレベルの英語力 • Legal right to work in the country where the role is based

🏖️ Benefits

• 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

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