＜Basic Purpose of the job＞
Plan, write, and manage clinical trial reports and contribute to other clinical documents essential for obtaining marketing approval worldwide. Provide critical input to the analysis and interpretation of clinical data.
1．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.
・Quality and timeliness of clinical documents. Compliance of documents with international guidelines and corporate SOPs. Successful and efficient interaction with 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.
・Quality of CTRs and compliance with relevant SOPs. Stay within timeline and budget.
3．Adhere to and improve medical writing standards.
・Knowledge of and compliance with CTR standards. Extent and quality of contribution.
4．Contribute to the organizational development of Clinical Operations Japan as a member of the organization－ participate in different initiatives within COJ as appropriate
・feedback of stakeholders
Skills and Competencies Ability to effectively communicate complex clinical information in writing for the target audiences; capacity to structure text and data in a clear and concise fashion; ability to convey data patterns in text, tables, or graphs.
Scientific and analytical thinking; understanding of medical concepts, statistics, pharmacokinetics, and pharmacodynamics; ability to comprehend and interpret clinical data; understanding of the clinical development process.
Project management skills including time management; ability to manage projects effectively across regions; strong interpersonal and social skills; ability to communicate effectively in international cross－functional teams; diplomacy; cultural and political sensitivity; presentation skills; ability to achieve results in complex matrix environments; proficiency in word
＜Special Work Experience＞
Leadership experience （1－3 years leading projects） and international experience （international exposure in daily business> 3 years or worked abroad > 1.5 years）.
＜Language Skills ＆ Proficiency＞
Degree / education：
Bacheloes Degree 学部卒 Or Masters Degree eg MBA or MSc 博士修了
Or Doctoral Degree eg. PhD or MD 博士修了
Major, focus：Medicine 薬学、Life Science
Sound knowledge in regulatory writing, including clinical trial reports of all clinical phases and other clinical documents; understanding of international writing standards and conventions.
Good knowledge in 1 therapeutic area and its clinical standards.
Sound knowledge in clinical documents standards and regulatory requirements.
Effective negotiation skills in the definition of timelines and deliverables.