【1100～1600万円】【R D】 Clinical Regulatory Writer （CReW） 研究開発本部 薬事…

【求人No NJB2303392】
■ 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.

【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）