・規制毒性(例:申請資料作成、人の安全性評価、関連業務など)での3年以上の経験 または 実験毒性学におけるラボスタッフまたは試験モニターとしての経験
・関連する規制/ガイドラインおよび GLP の理解
・製薬業界における医薬品開発への参画経験(5年以上)
・前臨床代表として規制当局への申請に関与した経験(2製品以上が望ましい)
・その他の一般的なスキルおよびコンピテンシーとして、論理的思考能力、問題解決能力
【求められる経験・スキル / Required Experience And Skills】
・日本国内で実施される臨床試験に参加するボランティアや患者の安全性を確保するため、前臨床毒性試験データを評価する
・日本で開発段階を進めるために必要な毒性試験データパッケージについて、その妥当性、科学的品質、規制遵守を確保する
・重要な毒性学的所見を特定し、適切な軽減戦略やリスク低減策を提案する
・臨床試験開始、PMDA 相談、NDA 提出に必要となる高品質な毒性学文書を作成する
・規制当局からの質問を含む、毒性学に関連する社内外からの問い合わせに対し、グローバルチームと緊密に連携して対応する
・デューデリジェンス活動の一環として、候補化合物を毒性学的および規制面から評価する
・グローバル PCD(Preclinical Development)組織の一員として、グローバルの前臨床開発イニシアチブや部門横断プロジェクトに積極的に貢献する
・ジュニアスタッフの指導・育成を行い、強固な毒性学専門性の構築を支援する
【学歴】
大学卒業以上
【職種 / type of occupation】
研究、非臨床
【給与 / salary】
年収 800 〜 1,230万円
【賞与】
【雇用形態 / employment status】
正社員
雇用期間
期間の定めなし
試用期間
有り
【就業時間 / working hours】
09:00~18:00
【休日休暇 / holiday】
土曜日 日曜日 祝日
【保険 / social insurance】
健康保険 厚生年金保険 雇用保険
受動喫煙防止措置
敷地内禁煙
【特長 / features】
女性活躍中, 上場企業, 外資系企業, フレックスタイム制, 土日祝休み, グローバル人材歓迎
【業種 / industry】
医療機器・医療品関連
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