医療・医薬の医薬品 in 東京都

posted
job type
正社員
salary
¥ 10,000,000 年棒
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job details

posted
location
東京都
job category
医薬品・医療機器
job type
正社員
salary
¥ 10,000,000 年棒
experience
10年間のメディカルライター経験が望ましい 「先駆け ・アクセレイトプログラム」持っていてほしい。この数年でその経験があると尚可
reference number
58068-13
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job description

社名
社名非公開

職種
医薬品

業務内容

Contribution as a medical writer in his expertise mainly clinical parts for all regulatory documents (CTD, briefing document for consultation, etc.) and positive involvement in strategic regulatory discussion during entire drug development process and also J-NDA from submission to approval for Biogen's programs


 


・Preparation of CTD in M1, M2 (clinical parts) and M5


・Preparation of response documents to PMDA questions during approval review


・Preparation of briefing document (BD) for PMDA Consultation regardless informal and formal


・Preparation of response documents to PMDA questions during PMDA consultation


・Preparation of relevant attachments to CTN such as IB, protocol, informed concent and others


・Preparation of response documents to PMDA questions during clinical application (CTN)


・Communication with global teams to get necessary information and supports


・Vendor management necessary for all document preparation including translation and edition



求められる経験
10年間のメディカルライター経験が望ましい

「先駆け ・アクセレイトプログラム」持っていてほしい。この数年でその経験があると尚可

保険
社会保険完備

待遇・福利厚生
各種福利厚生制度

休日休暇
完全週休二日制、ほか

給与
年収1000 ~ 1300万円