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 |
英語 (ビジネスレベル) 日本語 (流暢に話せるレベル) |
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
Global Pharmaceutical Maker
Job Description
1. Be responsible for clinical documents on study level or project level, as assigned. This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines. Contribute to scientific and regulatory discussions within the trial teams.
2. Ensure quality of clinical documents (study-level, or project level as appropriate) assigned to external providers by appropriate oversight and training. Contribute to appropriate budget planning and cost control.
3. Adhere to and improve medical writing standards.
4. Contribute to the organizational development of Clinical Operations Japan as a member of the organization
Requirements
・Sound knowledge in regulatory writing, including clinical trial reports of all clinical phases another clinical documents.
・Understanding of international writing standards and conventions.
・Good knowledge in 1 therapeutic area and its clinical standards.
・Ability to effectively communicate complex clinical information in writing for the target audiences.
・Leadership experience (1-3 years leading projects)
・International experience (international exposure in daily business > 3 years, or worked abroad > 1.5 years).
・Minimum Bachelor degree in Pharmacy, Medicine or Life Science
面接について
連絡先
Medical Writing, Clinical Operations
RGFタレントソリューションズ株式会社
600 〜 1200 万円