仕事概要
職種 | 専門職(コンサルタント、金融、不動産、専門サービス)/専門サービス(医療、福祉、教育、インストラクター) |
---|---|
業種 | 医療/ その他医療 |
雇用形態 | 未分類 |
ポジションレベル | その他 |
募集人数 | 1名 |
希望入社時期 | - |
必須語学力 |
日本語 (流暢に話せるレベル) 英語 (ビジネスレベル) |
活かせる語学 | - |
勤務時間 | その他 |
福利厚生・休暇 | |
ビザ取得支援 | - |
外国人従業員 | - |
仕事詳細
Company Overview
Pharmaceuticals Company
Job Description
・ A senior level scientific writer who creates basic clinical/regulatory
documents (e.g. CTD M2.7.6), complex clinical/regulatory documents
(e.g. CTD M2.7.3/2.7.4, CSR) and high level clinical/regulatory documents (e.g. CTD M2.5, responses to Health Authority) independently, ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
・ Participate in relevant filing subteam(s) and ensure effective planning
and management of timelines for clinical/regulatory documents of assigned projects.
・ Comply with internal and external processes and guidelines while
managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
・ Review and edit other clinical/regulatory documents as required.
Requirements
・ PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a
minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent.
・ Good understanding of global pharmaceutical drug development and
requirements for submission of regulatory dossiers to global health
authorities.
・ Demonstrated strong writing skills both in Japanese and in English,
preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA.
・ Ability to analyze and interpret complex data from a broad range of
scientific disciplines.
面接について
連絡先
Expert Scientific Writer
RGFタレントソリューションズ株式会社
600 〜 1300 万円