【R D】 Clinical Regulatory Writer （CReW） 研究開発本部 薬事統括部 薬事オペレーション…

【求人No NJB2366297】
■ 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.

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