【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 1

■ 職務内容 / Job Description

Clinical Regulatory Writer (CReW) is responsible for the authoring of clinical-regulatory documents 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 CTD / BD for PMDA consultations / CSP / MICF / CSR / IB, in line with the project communication strategy, and ensure quality and efficiency in delivery.
CReW provides leadership and communications expertise at the clinical drug program level, specifically in the authoring of clinical-regulatory documents, across multiple drug projects simultaneously, and oversees the cross-product documentation within the disease area.

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

【経験 / Experience】

＜必須 / Mandatory＞

• Significant medical writing experience in the pharmaceutical industry.
• Delivery of regulatory submissions including CTN, JNDA/sJNDA and responses to PMDA/MHLW queries during the review process.
• Comprehensive knowledge of the drug development process, including key regulations/guidelines (e.g., GCP, ICH GLs), and knowledge on a “need to know basis” in relevant therapeutic area

＜歓迎 / Nice to have＞

• Experience in leading the preparation of clinical regulatory documentation at the development strategy level.
• Experience in supervising internal communications and outsourced writing.
• Experience with digital tools and 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

Date Posted

25-8月-2025

Closing Date

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.

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 authorisation and employment eligibility verification requirements.