【AstraZeneca】【R&D】 Clinical Regulatory Writer (CReW), 研究開発本部 薬事統括部 薬事ｵﾍﾟﾚｰｼｮﾝ部 ｸﾘﾆｶﾙ ﾚｷﾞｭﾗﾄﾘｰ ﾗｲﾃｨﾝｸﾞ ｽﾄﾗﾃｼﾞｰﾄﾞｷｭﾒﾝﾄｸﾞﾙｰﾌﾟ 2

Job Description

■ 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(経験、資格等)/ Qualification (Experience & Skill etc.)

【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 writing.

【資格 / License】

<必須 / Mandatory>

• Bachelor’s Degree in Science or related discipline

【能力 / Skill-set】

<必須 / Mandatory>

• Medical writing skill
• Logical thinking/Presentation skill to express intention in an efficient way in Japanese & English
• Interpersonal and communication skills with team member or stakeholders
• Facilitation skill to lead an innovative solution in conflicting discussion

【語学 / Languages】

<必須 / Mandatory>

• 日本語 Japanese:Native Level
• 英語 English:Business English (Achieve common understanding at the context level with customers)

【キャリアレベル / Career Level】

E

【勤務地 / Work Location】

Osaka or Tokyo

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.