募集要項
- 仕事内容
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【Remote & Flextime OK】＜Main Tasks＞
No TA expertise or Japanese language skills required!
・Create clinical and regulatory documents (CSRs, protocols, CTDs)
・Lead writing and submission of clinical sections for global filings
・Supervise outsourced writing and manage vendor contracts
・Analyze text/data and review analysis plans and figures
・Drive process improvements and implementation of writing standards
＜Why Join Us＞
・Open to all TA backgrounds – No TA experience needed
・No Japanese required
・Hybrid & super-flex time work style
- 応募資格
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- 必須
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・Bachelor’s degree in a scientific field
・Business-level English (written & spoken)
・7+ years of medical writing experience in the pharmaceutical industry (including clinical/regulatory documents)
・Knowledge of drug development processes
・Understanding of scientific and statistical principles in clinical research design and reporting
・Familiarity with ICH and GCP guidelines
・Ability to interpret and document clinical data clearly and accurately
・Proven leadership in cross-functional teams to deliver high-quality clinical documents
・Basic PC skills and computer literacy
- 歓迎
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・Master’s degree or equivalent in Life Sciences, Medicine, Pharmacy, etc.
・PhD, MD, or PharmD
・Medical writing experience in Oncology (e.g., clinical overviews, CSRs, responses to authority queries)
・Experience mentoring junior medical writers
・Global medical writing experience
・Knowledge of Oncology drug development
・Basic understanding of biostatistics and pharmacokinetics
＜Skills & Competencies＞
・Strategic and logical thinking with strong planning ability
・Understanding of digital tools and automation for writing efficiency
・Strong project management skills
・Commitment to high writing standards and continuous improvement
・Flexibility and proactive problem-solving attitude
・Excellent negotiation and influencing skills
- 雇用形態
- Employment Condition: Full-time (Permanent)
- 勤務地
- Location: Tokyo – Remote work option available
- 勤務時間
- Work Style: Super Flextime
- 年収・給与
- Annual Salary range: ¥12M–¥18M (Plus long-term incentive plan)
- 休日休暇
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Holidays: Weekends, national holidays, and company-designated days
