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

Company overview

大手外資系製薬会社

Job description

【職務内容】
■グローバルを含む社内ステークホルダーと協力して日本での新薬承認申請のための臨床薬理概要の文書作成や当局照会事項対応の主導
■ファーマコメトリクス解析遂行ならびにレポート作成業務において下位者を指導し、早期上市に貢献

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

Requirements

・臨床薬理全般に関する広範な知識
・PPK及びER解析に関する知識
・医薬品開発全般およびそれらの規制文書に関する知識

・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

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