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This posting is managed by: | Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社 |
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Company Name | Company is not publicly visible |
Job Type |
![]() Medical/Pharmaceutical/Bio/Fabric/Food - Other |
Industry | Pharmaceuticals |
Location |
Asia
Japan
|
Job Description |
Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Description * Take lead in authoring clinical and regulatory documents as well submission requirements * Focusing on clinical parts of documentation such as CTD, CSR, IB, etc. to align company objectives in an efficient manner * Coordinate with other documentation support with external vendors such as CROs * Authoring clinical parts for briefing documents for PMDA consultation and review other requirements Profile * University degree in scientific or related field * Fluency in English and Japanese (non-native level speakers will not be selected) * Experience in clinical development with comprehensive knowledge of overall drug development process * Track record in writing clinical documents, delivery in regulatory submissions * Deep knowledge of regulations and guidelines * Experienced in supervising outsourced resources Job Offer * Competitive salaries and benefits * Great work life balance * International working environment * Amazing career progression in medical writing * Work with industry leaders who are solving various unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy. |
Company Info |
* One of the top global biopharmaceutical companies in the industry * Specializing in oncology, infectious diseases, cardiovascular, rare disease, and other TAs for various unmet medical needs * Patient-centric organization with cutting edge products and therapies * Heavy investment in new drug development as well new research * Global cultured organization |
English Level | Business Conversation Level (TOEIC 735-860) |
Japanese Level | Native Level |
Salary | Depends on experience |
Recruiter
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社