​【Remote & Flextime OK】
*No TA expertise or Japanese language skills required!

＜Main Tasks＞

・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

＜Requirements＞

【Mandatory】
・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

【Preferred】
・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

＜Company Profile＞

Global biopharmaceutical company:
・Engaged in the development and manufacturing of innovative medicines worldwide.
・Focused on specialty areas with a strong and stable pipeline, offering an excellent and secure working environment.

＜Working Condition & Others＞
Employment Condition: Full-time (Permanent)
Annual Salary range: 12M JPY to 18M JPY (Plus long-term incentive plan)
Location: Tokyo, Remote work option available
Work Style: Super Flextime
Holidays: Weekends, national holidays, and company-designated days
Industry: Pharmaceutical

＜Appealing Points＞
・Open to all TA backgrounds, No TA experience needed
・No Japanese required
・Hybrid & super-flex time work style
Please feel free to contact us for more details!