・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
※詳細はお仕事のご紹介時にお伝えします
Job ID: VAC-284729/
-
Greater Osaka Area Randstad Japan ¥8,000,000 - ¥12,300,000 per year規制毒性での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が求められます。 · 関連する規制/ガイドラインおよびGLPの理解も必要です。 · 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) · ...
-
Greater Osaka Area Randstad JapanCMC薬事マネージャーを務める。 · CMP関連の規制当局対応業務を監督し、主導する。 · ...
-
Osaka IQVIA Full timeThis is an Operations Specialist role at IQVIA Japan. The successful candidate will have experience in medical institutions' contact centers or call centers. · ...
-
Osaka Patina Hotels & ResortsDrive brand awareness and revenue growth for the restaurant through targeted campaigns and promotions across digital social offline channels. · Tertiary education in Marketing or Sales · At least 2 years of work experience in the field · ...
-
Osaka Medtronic Full timeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. · ...
-
Osaka, Osaka Skyworks Solutions, Inc.Job summary: Interpreter (Project Coordinator). If you are looking for a challenging and exciting career in the world of technology, then look no further. Skyworks is an innovator of high performance analog semiconductors whose solutions are powering the wireless networking revol ...
-
Sales RepⅠ
2ヶ月前
Osaka, Osaka Medtronic ¥4,000,000 - ¥6,000,000 per year+Sales Representative I (NM @ Osaka) · ++ Medical professionals and distributors with Medtronic products. · + Demonstrations and technical support to customers in the assigned region. · + Drafting and implementing sales strategies for the assigned region. · + Events such as confe ...
-
Osaka TencentLightSpeed Japan Studio is a game development studio dedicated to crafting original AAA action game titles for global audiences. · ...
-
Osaka Patina Hotels & ResortsThe Sonata Lounge and Bar Manager is responsible for ensuring that all bar systems and procedures are properly followed while maintaining service standards and achieving total guest satisfaction.The role involves overseeing the hotel's overall beverage program as needed conductin ...
-
Osaka IQVIAWe create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. · The role involves working in an operations capacity for a team focused on clinical research s ...
-
Treasury, Japan
2週間前
Kyobashi, Tokyo Astellas PharmaThis position is responsible for corporate finance functions at the headquarters including integrated analysis management P L balance sheet cash flow based mid long term business plans formulation financial strategies initiatives optimal capital structure funding requirements. · ...
-
Osaka TencentLightSpeed Japan Studio is a game development studio dedicated to crafting original AAA action game titles for global audiences. · The studio offers a flexible and inclusive work environment and actively welcomes game creators who are full of talent and passion for pushing the bo ...
-
Kyobashi, Tokyo Astellas PharmaJoin our team as a Logistics Coordinator where you will contribute to the creation of value by working across various functions including Supply Chain Management. · Coordinate logistics activities including procurement and transportation of goods. · ...
-
Osaka ERM ¥600,000 - ¥1,800,000 per yearEHS consulting services for large-scale construction projects, conducting audits at various sites, performing health and safety inspections and evaluations, preparing technical reports. · Provide EHS consulting services for large-scale construction projects. · Conduct EHS audits ...
-
Osaka, Osaka Johnson & Johnson Innovative MedicineAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured. · ...
-
〒- 大阪府 大阪市 北区 大深町, AstraZenecaThe Associate Brand Manager will contribute to maintain sustainably competitive position of AZ in the industry by maximizing the value of AZ science through delivering benefits of science to as many patients as possible. · ...
-
Osaka Patina Hotels & ResortsThe Assistant Director of Rooms supports the Director of Rooms in overseeing all Rooms Division operations. · Support the Director of Rooms in managing daily Rooms Division operations (Front Office, Guest Services, Housekeeping, Recreation) · Ensure a seamless and personalized gu ...
-
Osaka Equinix Full timeHas a substantial understanding of the job while working on assignments that are moderately difficult requiring judgement in resolving issues or making recommendations. · ...
-
Osaka, Osaka IQVIAIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments ...
-
Greater Osaka Area HaleonWe are seeking a Sales Expert to promote our products to dentists and dental professionals in the Greater Osaka Area. The ideal candidate will have experience in sales and be able to communicate effectively with customers. · ...
-
Sr. Workplace Health
3週間前
Greater Osaka Area AmazonAmazon seeks an experienced Safety Manager to join our Workplace Health & Safety (WHS) team in pursuit of our vision to become Earth's safest workplace. · ...