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新薬の臨床試験計画・申請業務を主導｜臨床開発経験者募
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 6 million yen ~ 15 million yen |
Job Description
グローバルで開発中の新薬の国内導入に向けた臨床開発を推進し、承認取得・上市に貢献するポジションです。臨床試験計画の策定からPMDA対応まで、幅広く戦略的に関与していただきます。
企業情報
海外本社を持つグローバル製薬企業の日本法人で、新薬の臨床開発および日本市場での承認取得に注力しています。
職務内容
- 国内における臨床開発計画の立案および最終化
- PMDA相談およびプロトコール作成
- 承認申請資料の作成および照会事項対応
- 海外チームやCROなど社内外ステークホルダーとの協働
- 承認取得に向けた臨床試験全体の推進
条件・待遇
- フレックスタイム制度
- 在宅勤務制度
- 各種社会保険
Page Group Japan is acting as an Employment Agency in relation to this vacancy.
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | No permission to work in Japan required |
Required Skills
- 新薬の臨床開発経験5年以上
- 臨床開発計画およびプロトコールの作成経験
- PMDA相談の実施経験
Job Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 6 million yen ~ 15 million yen |
| Industry | Pharmaceutical |
Job Category
- Medical, Pharmaceutical and Healthcare > Other (Medical, Pharmaceutical and Healthcare)
- Medical, Pharmaceutical and Healthcare > R&D (Pharmaceutical)
