The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team. Reporting to the Head of Global Regulatory Affairs CMC you will partner
Career CategorySales & Marketing Operations Job Description Job Description BA＆I aims to become an engine of change for the entire commercial organization to provide the highest level of customer excellence, embodying the idea of To Serve
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Work Flexibility: Hybrid or Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
About AIG American International Group, Inc. (AIG) is a leading global insurance organization. Founded in 1919, today AIG member companies provide a wide range of property casualty insurance, life insurance, retirement products, and other financial services
シティ（Citi）は、100年以上前に日本に参入し、1902年の横浜拠点開設以来日本の金融市場に根ざしてきたグローバル金融機関です。現在は東京・大手町を主要拠点とし、国内大手企業・金融機関・機関投資家・公共機関をはじめ、日本市場で事業を展開する海外多国籍企業や国際的な機関投資家に対して、幅広い金融サービスを提供しています。 Markets Operationsは、シティグループ証券のマーケッツ部門を支える中核機能として、国債・社債・株式といった標準的な金融商品から、顧客ニーズに応じた仕組み債・デリバティブ、外国為替・株式・金利を組み合わせたハイブリッド商品やコモディティに至るまで、幅広いプロダクトの取引執行・決済・リスク管理を一貫して担っています。グローバルなネットワークと日本市場における深い専門知識を兼ね備えたチームとして、高い水準のクライアントサービスと業務品質の維持・向上を共通の目標に掲げています。 Citi is looking for a senior operations leader to take ownership of securities and derivatives settlement across fixed income, equity and cross-border markets within its Japan operations, as a Securities Operations Manager in
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Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of
Job Description Purpose of the role To support the development of audits aligned to the bank’s standards and objectives by working collaboratively with colleagues, providing accurate information and recommendations, and complying with policies and procedures. Accountabilities
Job Purpose and Impact BAND DESCRIPTION Supervises established and seasoned professionals and may also supervise support level employees. Sets goals and objectives for team members for achievement of operational results. May focus on policy and strategy
Job Description ・医薬品開発戦略に対して、臨床薬理/ファーマコメトリクスを活用した提案を行い、早期承認に貢献する ・他チームや臨床現場に対して、治験薬の臨床薬理学的情報を的確に提供するとともに、問題解決を行う ・プロトコールの試験デザイン・被験者数・解析方法並びに試料のサンプリングポイントなどを検討し、適切な提案を行う ・薬物動態（PK）解析を実施し、治験総括報告書の該当するセクションを作成する ・PK結果の速報を作成し配信する。 ・臨床現場に提供すべき治験薬の臨床薬理/薬物動態学的情報を精査し、非臨床ADMEを含む申請資料の臨床薬理関連部分に過不足無く盛り込む ・臨床現場に提供すべき治験薬の臨床薬理/薬物動態学的情報や用法・用量に関連する臨床薬理領域の電子データを特定し、戦略に応じて、適切に提出する ・PMDA相談の資料作成・当日の議論に臨床薬理担当者として加わり、承認に貢献する ・本社の担当者と継続的に連絡を取りながらこれらの業務を進める。 ・必要に応じてモデリング＆シミュレーション（M＆S）を実施する ・グループ内のM&Sスキル向上への提言及び下位部員に対するメンターとして教育・指導的役割を担う 応募条件 【必須（MUST）】 ・臨床薬理部門もしくは関連部門での3年～10年程度の実務経験 ・M＆S（population PK, PK－PDまたはExposure－Response解析）の知識・理解 ・非臨床ADMEの知識・理解 ・ノンコンパートメントPK解析の知識・理解 【歓迎（WANT）】 ・ノンコンパートメントPK解析の実務経験 ・M＆S（population PK, PK－PDまたはExposure－Response解析）の実務経験 ・各品目のプロジェクトチーム内で、他のメンバーと積極的に関わって議論/プレゼンできる方 ・海外の担当者とのメール、電話等でのコミュニケーションが可能で、関係を構築できる方 ・CDISC / non－CDISCの電子データ申請に関する基礎知識・経験があれば尚可 ・博士号（PhD）であれば尚可 Required Skills: Clinical Trial
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are,
About The Opportunity We are seeking experienced healthcare and social assistance professionals to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will help create and review realistic
About The Opportunity We are seeking experienced professionals in Finance and Financial Services to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality,
Career CategoryClinical Job Description Job Purpose This position is responsible for providing statistical expertise and leadership for clinical development and regulatory filing activities in Japan as a member of Global Biostatistical Science Japan Biostatistics. The role will
Our Mission At Palo Alto Networks®, we’re united by a shared mission—to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking.
Job Purpose At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
About The Opportunity We are seeking experienced professionals in Mathematics to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality, real-world mathematical scenarios
About The Opportunity We are seeking experienced professionals in Robotics to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality, real-world natural sciences