Senior Medical Writer

ICON plc

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

Posted 11/5/2026full-timeRemote • JapanSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in medical writing for clinical research, including the preparation of clinical study protocols, reports, and regulatory submissions. Proficient in interpreting clinical trial data and collaborating with cross-functional teams to support clinical development initiatives.

Highest-signal resume keywords

Medical Writing ExpertiseRegulatory Requirements KnowledgeClinical Trial Data InterpretationExcellent Writing And Editing SkillsMentoring And Coaching

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Study Protocol PreparationClinical Study Report WritingRegulatory Submission DocumentationStatistical Analysis InterpretationPublication PlanningDocument ReviewClinical Trial Data SummarizationCTD Documentation CreationInteracting With Regulatory AgenciesScientific Manuscript Development

Soft Skills

Excellent Interpersonal SkillsEffective CommunicationCollaboration With Cross-Functional TeamsProject ManagementInfluencing Decision-Making

Industry Keywords

ICH-GCPFDAEMAClinical ResearchPharmaceutical IndustryCRO ExperienceHealthcare-Related FieldScientific ConferencesPeer-Reviewed JournalsRegulatory Affairs

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
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

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 (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

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