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Location Japan - Tokyo
Industry Life Sciences & Healthcare > Pharmaceuticals
Job functions Healthcare R & D > Clinical Development
Job number JO-180605-164220

Company overview


Job description


1. ファーマコメトリク解析計画、実行および報告
2. 医薬品申請業務におけるCTD臨床薬理パートの作成
3. グローバル CP&P部門との連携推進・維持
4. 臨床薬理観点からの臨床開発チームへの助言
5. ファーマコメトリクス業務のグローバル標準化
6. ファーマコメトリクス技能レベルの向上
7. ファーマコメトリクス業務に関するグローバル部門との連携

1. Responsible for planning, execution and reporting in pharmacometric-analyses
2. Responsible for all aspects of clinical pharmacology parts in NDA filing.
3. Keep alignment with global team through connections with Global CP&P
4. Provide advices on development team as an expert of clinical pharmacology
5. Communicate with global CP&P to align pharmacometric practice with global their standards.
6. Train Pharmacometrics skill levels to be higher.
7. Negotiation with global R&D functions for planning/execution/reporting



・Extensive knowledge on all over clinical pharmacology as an expert of Pharmacometrician
・Knowledge on pharmacokinetic and statistical analysis on PK, popPK and E-R analysis
・Knowledge on full process of pharmaceutical development and its global regulatory guidance/guidelines