Medical Writer

---

Job details

Company overview

Our client is a global healthcare corporation. Driven by its mission and aspirations, the organization is fully committed to safeguarding public health. This commitment is demonstrated through ongoing endeavors involving the research, development, importation, manufacturing, and distribution of medicines and vaccines. Its parent company is headquartered in the United States.

Responsibilities

• Preparation of investigational drug summary (IB)
• Preparation of a general report (CSR)
• Creation of Approval Application Material (CTD) Clinical Part
• Preparation of draft package insert (clinical part) for development products
• Preparation of face-to-face advice (pre-application consultation) materials
• Creating answers to inquiries regarding clinical parts after application for approval
• Publication of clinical trial results on the clinical trial information registration site

Requirements

Have one of the following experiences:

• Experience in creating CTD clinical part (module 2.5, 2.7.3, 2.7.4, 2.7.6) or clinical pharmacology part (module 2.5, 2.7.2, 2.7.6)

 

• Experience in creating clinical trial implementation plans, clinical trial summary reports, and face-to-face advisory materials
• CRA experience
• Ability to analyze and interpret scientific thinking and clinical trial data
• English ability (TOEIC 730 points or more, you can negotiate without problems at meetings and emails with overseas headquarters)
• Communication skills (have interpersonal coordination and can build good relationships with stakeholders)
• Project management ability (can make execution plans for multiple tasks and control tasks and risks so that the objectives can be achieved with appropriate deadlines and qualities)

Salary

8 - 12 million yen

Location

Tokyo