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| 部署・役職名 | メディカルライター |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Medical Communication Scientist （MCS） is a role name in AZKK and is generally known as ”medical writer”. MCS is responsible for the authoring of clinical－regulatory documents and submission packages that communicate the evidence base of product knowledge in a credible, consistent and compliant way. MCS leads the authoring of the clinical parts of documents such as CSP / MICF / CSR / IB / CTD / Regulatory defences, in line with the project communication strategy, and ensure quality and efficiency in delivery. For CSP/MICF/IB, MCS centralize and coordinate those developments using external vendors across clinical studies. MCS also contributes the authoring of the clinical parts of the briefing documents for PMDA consultations to improve communication quality of documents. MCS reviews other clinical documents with the purpose of facilitating the translation of Target Product Claims into a fully－supported proposed product label, and to improve communication quality of documents |
| 応募資格 |
【必須（MUST）】 Candidates with medical writing experienceOR Candidates with NO medical writing experience （but with previous pharma experience, such as CRA, Clinical Leader, Project Manager） 【歓迎（WANT）】 ・Experience in Clinical Development・A comprehensive knowledge of the drug development processes including key regulations/guidelines（e.g. GCP, ICH GLs）, and knowledge on a “need to know basis” in relevant therapeutic area ・Experience in medical communications gained through working in the pharmaceuticals industry or a medical communications agency ・Delivery of regulatory submissions including CTN, JNDA/sJNDA and response to PMDA/MHLW queries during review |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/05/08 |
| 求人番号 | 3507556 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です