BRS Consultant
Linh Do
Medical Device
Job number: JN -072024-18380
Posted: 2024-09-11
Clinical Lead
World's number 1 Ophthalmology company
10 - 14 million yen
Tokyo
Medical Device
Clinical Trials / Clinical Development
Job details
- Company overview
- We are a leading ophthalmic care company. We focus on the development and marketing of products and services that support eye health, including contact lenses and ophthalmic surgical instruments for improving vision and eye care. With a focus on innovation, we aim to solve vision-related problems and improve the quality of life by providing high-quality, safe products. We are also committed to social action programs and sustainable business models.
- Responsibilities
-
- 開発戦略の作成・立案
- 国内臨床試験計画の作成及び実施（プロトコール作成、総括報告書作成、CROマネジメント）
- 海外臨床試験データの評価（効能効果、適応疾患などの観点から）
- 承認申請資料の作成、承認申請後の対応（PMDA照会事項への回答作成等）
- PMDA適合性調査の準備
- PMDA対面助言相談の実施
- 臨床研究の実施 （プロトコール作成からデータベース固定まで）
- Requirements
-
Minimum requirements (experience)
- ビジネス英語中級以上（読み書き、Web会議での報告が可能なレベル）: Intermediate Business English skill, reading, writing and reporting at web-based meetings
- 医薬品又は医療機器GCPに関する業務経験（7年以上）: Job experience of GCP for Pharmaceutical or Medical Device（7 years or more）
- プロジェクトをリーダーとして率いた経験 : Experience of a Project Leader
- 臨床開発計画立案経験 : Experience on the Planning of the Clinical Development strategy
- PMDA相談やPMDAからの照会事項対応等の経験 Experience of PMDA consultation or preparing responses for PMDA inquiries
- 経験に応じてポジションは検討します。
- Salary
- 10 - 14 million yen
- Location
- Tokyo