【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

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.

Qualification (Experience & Skill etc.)

Experience】

Mandatory＞

• A comprehensive knowledge of the drug development processes including key regulations / guidelines( 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

Nice to have＞

License】

Mandatory＞

Skill-set】

Mandatory＞

Languages】

Mandatory＞

Career Level】

Work Location】

Osaka or Tokyo

Date Posted

09-5月-2025

Closing Date