Company OverviewGlobal Pharmaceutical Maker
Job Description1. Be responsible for clinical documents on study level or project level, as assigned. This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines. Contribute to scientific and regulatory discussions within the trial teams.
2. Ensure quality of clinical documents (study-level, or project level as appropriate) assigned to external providers by appropriate oversight and training. Contribute to appropriate budget planning and cost control.
3. Adhere to and improve medical writing standards.
4. Contribute to the organizational development of Clinical Operations Japan as a member of the organization
Requirements・Sound knowledge in regulatory writing, including clinical trial reports of all clinical phases another clinical documents.
・Understanding of international writing standards and conventions.
・Good knowledge in 1 therapeutic area and its clinical standards.
・Ability to effectively communicate complex clinical information in writing for the target audiences.
・Leadership experience (1-3 years leading projects)
・International experience (international exposure in daily business > 3 years, or worked abroad > 1.5 years).
・Minimum Bachelor degree in Pharmacy, Medicine or Life Science