外資大手製薬メーカー Medical Writer, R&D Regulatory Division
- 会社区別外資系製薬メーカー
- 職種Medical Writer, R&D Regulatory Division
- 勤務地大阪市北区、東京都港区
- 年収600万円～1,200万円
資格・要件
＜必須 / Mandatory＞
・Experience in Clinical Development
・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.
【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 / Language】
＜必須 / Mandatory＞
日本語 Japanese
英語 English：Business English (Achieve common understanding at the context level with customers)
職務内容
Medical Communication Scientist (MCS) is a role name in 〇〇 and is generally known as "medical writer". MCS 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.
MCS 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, MCS centralize and coordinate those developments using external vendors across clinical studies.
MCS also contributes the authoring of the clinical parts of the briefing documents for PMDA consultations to improve communication quality of documents. MCS 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
【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:15
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇 初年度12日
年間休日日数121日
■公休日：完全週休2日制(土、日)・祝日・年末年始6日
■休暇：年次有休休暇・慶弔・赴任・リフレッシュ
受動喫煙対策：あり 就業場所 全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有
