【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 ｽﾀﾃﾞｨﾄﾞｷｭﾒﾝﾄｸﾞﾙｰﾌﾟ

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 CSP / MICF / CSR / IB, 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.
 

Requirements

経験 Experience

<必須 Mandatory>

・Medical Writing Skill/Experience
・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

<歓迎 Nice to have>

・Significant medical writing experience in pharmaceuticals industry
・Experience in leading the preparation of clinical regulatory documentation at the development strategy level.
・Delivery of regulatory submissions including CTN, JNDA/sJNDA and response to PMDA/MHLW queries during review
・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：Reading & Writing

Date Posted

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.