Medical Writer

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Job details

Company overview

We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people's health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

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