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
About the role At Adobe, we’re changing the world through digital experiences. Within Education, our mission is to empower institutions, educators, and students to develop, communicate, and learn more effectively using Adobe technologies. The Solutions Consultant, Education
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can
JOB DESCRIPTION: Job Description About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott,
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can
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Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global
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Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global
Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global
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Company Description It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could do
企業概要 The Wabtec Mining team delivers world class drive systems for heavy haul mining trucks ranging up to 400T with a developing focus on sustainability technology introduction. In this role, the Senior Systems Engineer will lead cross
Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global