Senior Medical Writer

This is a fully remote position, open to applicants in Japan.

📋 Description

• Spearhead the formulation and implementation of medical writing strategies for clinical research initiatives.

• Take ownership of medical writing outputs and leverage expertise to address intricate challenges.

• Draft, review, and refine clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions.

• Work in collaboration with clinical research, biostatistics, regulatory affairs, and medical affairs teams to analyze clinical trial data and distill scientific insights.

• Engage in the planning and execution of clinical development programs.

• Offer strategic insights and scientific knowledge to facilitate the design, execution, and interpretation of clinical studies and research projects.

• Create publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences.

• Mentor and guide 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.

• Proficient in interpreting and summarizing intricate clinical trial data, scientific research findings, and statistical analyses.

• Exceptional writing, editing, and proofreading capabilities.

• Strong grasp of regulatory requirements (e.g., ICH-GCP, FDA, EMA).

• Experience in engaging with regulatory agencies during the review and approval phases.

• Ability to thrive in a fast-paced, deadline-oriented environment.

• Skilled at managing multiple projects concurrently and prioritizing tasks based on project timelines and deliverables.

• Excellent interpersonal and communication abilities.

• Proven ability to work collaboratively with cross-functional teams, foster 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 along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.