募集要項

仕事内容: アストラゼネカ株式会社での募集です。
臨床開発メディカルライターのご経験のある方は歓迎です。
■ 職務内容 / Job Description
Clinical Regulatory Writer （CReW） 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.
CReW 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 CReW centralize and coordinate those developments using external vendors across clinical studies.
CReW also leads or contributes the authoring of the clinical parts of the briefing documents for PMDA consultations to improve communication quality of documents. CReW 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: 【経験 / Experience】
＜必須 / Mandatory＞
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

＜歓迎 / Nice to have＞
Experience in leading a preparation of clinical regulatory documentation.
Experience in supporting documentation preparation across programme and strategy level
Experience in supervising internal communication and outsourced writing.
Experience of any digital tool/ technologies in medical w…

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面談の際に、採用担当者からお聞きした情報やコンサルタント自身が感じた選考のポイントを皆さまへお届けします。

休日休暇: 【有給休暇】有給休暇は入社時から付与されます
【有給休暇】
初年度 4～16 日（ 1 か月目～）
入社月により付与日数が異なります。
詳細はオファー時に通知いたします。
【休日】完全週休二日制
年末年始
【有給休暇】※入社月により付与日数が異なります。詳細はオファー時に通知いたします

夏期休暇、年末休暇、慶弔、赴任、リフレッシュ、頭痛休暇等

会社概要