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Location | Tokyo - 23 Wards |
Job Type | Contract |
Salary | 10 million yen ~ Negotiable, based on experience |
【メディカルライター】
業務内容
■新薬の承認申請/審査業務全般(臨床分野)
*国内CTD臨床モジュールの作成 *PMDA/MHLW照会事項回答書の作成 ■PMDA/MHLW相談資料及び相談に係る照会事項回答書の作成
■Global担当者とのコミュニケーション(メール、会議等)
Minimum Experience Level | Over 3 years |
Career Level | Mid Career |
Minimum English Level | Business Level |
Minimum Japanese Level | Business Level |
Minimum Education Level | Bachelor's Degree |
Visa Status | Permission to work in Japan required |
応募要件
■製薬企業、CRO 又は研究機関でのメディカルライティング業務経験
■製造販売承認申請業務(国内CTD臨床モジュールの作成)及び承認審査対応業務(照会事項回答作成)の経験
■語学力:メールでの英語によるコミュニケーション、海外文献読解力・英文書翻訳・日本語能力は必須。会話(専門分野での協議、交渉)は流暢でなくてもGlobal担当者との意思疎通が取れ、良好な関係構築ができること
Job Type | Contract |
Salary | 10 million yen ~ Negotiable, based on experience |