The LSM ( Local Study Manager) acts on country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical approaches internally
■ Job Description / Capsule Responsible for new product planning and life cycle management of existing products pipeline to maximize its opportunity/value and contribute to pursue R&I vision “Be the indispensable partner in transforming patient life
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Job Description The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific and
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical development solution
Job Description Summary 職務内容サマリ The primary focus of Medical Science is to lead medical educational event planning/implementing, contents creation, process standardization for new operating model for contents and publication and to measure and communicate the value
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job Description Summary ノバルティスのプロセス、規制および倫理的要件に準拠し、薬物動態、バイオマーカー、安全性等に関わる生体試料の収集に関して、臨床試験へ実装し、臨床試験開始から終了までのOperationを担当します。また、コンパニオン診断に関連する業務についてもサポートする場合があります。 Job Description Major Accountabilities Lead Clinical Biospecimen Scientist(CBS)の監督下、社内関係者と協働し、戦略に基づき、臨床試験における生体試料に関する技術面・Operationに関連する業務を実行する。主に以下の業務を実施する。 - 臨床試験関連文書（治験実施計画書や同意説明文書など）の臨床評価項目に情報を提供する。 - 臨床試験固有のサンプル収集表を作成する。また、ラボマニュアルなどの関連文書も含め、ラボキットの作成、サンプルの管理、検査会社（Laboratory）に対して技術的側面を管理する。 - 生体試料のライフサイクル全体を通じて、サンプル管理（処分含む）、輸送を担当する。社内関係者および検査解析会社（Laboratory）と協働し、症例報告書（CRF）とデータ転送に関する要件を定義し、 タイムリーな分析、転送されたデータの品質を担保する。 Risk management: 社内関係者と協力し、生体試料の収集および分析に関連する臨床試験固有のリスクおよび問題を適切に報告する。 Resource management: Lead CBSの監督の下、Vendor managerおよびProcurementと協力して、検査会社（Laboratory）からの提案、予算情報、および請求書の確認をおこなう。 担当臨床試験および担当プログラムにおいて、標準業務手順書（SOP）を遵守し、Lessen and Learnなどを通じて最良の結果を求める。 Key Performance Indicators GCP, SOP, ICH等の遵守 社内関係者、および臨床試験チームからインプットをもらい、期限内にサンプル輸送ができる体制を整える
Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit) staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures the reliability of
The LSM ( Local Safety Manager)acts on country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective functions
Job Description Summary Lead scientific engagement with their Medical Experts. Implement clinical and educational strategies and respond to unsolicited medical enquiries. Job Description Major Accountabilities ~ 医療専門家(ME)と関わり、医療/科学的情報を教える ~ 支援提供のため特定の医療ニーズが確認された場合、ME を関与させる機会の特定を含め、ME/主要アカウントの適切な特定/マッピングを確保。 ~ 〜医療専門家とのエンゲージメントプランを作成・実施して、医療専門家と協力して国の戦略に沿った効果的な優先順位を決定する。 ~ MEからの未承諾の情報要求への対応 ~ 〜ノバルティスの臨床研究プログラムをサポート、治験の最適化、臨床業務と連携して現場の研究をサポートし、科学分野の教育を行う。 ~
Job Description Summary Develop the medical expert engagement plan(s) in assigned therapeutic area(s) and local areas under the direction and agreement of the Group manager. Job Description Develop the medical expert engagement plan(s) in assigned therapeutic
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical development solution
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Plan (VEP)とIntegrated Evidence Plan (IEP)の内容の企画・策定 およびその計画の実行に責任を持ちます。Evidence NeedsおよびGapを評価し、製品価値を高めるための最も 適切な試験やデータベース研究の計画を組織横断チームにて企画・立案・提案し、その実行とEvidenceの公表 までの広い責任と職務をリードしていきます。 また、ワクチン領域においては、定期接種や自治体の予防接種補助金の根拠となるCost Effectivenessモデルの構築やその推定結果をEvidenceとして公表すること、ならびに臨床開発早期の段階にある製品Pipelineに 対して、日本やアジアの疫学的な視点から助言し、承認取得までの臨床開発計画におけるEvidence Gapを 評価し、製品Launchの前後に必要な最適なVEP/IEPを企画・立案・提案することが求められます。 The VEO Expert contributes to plan, develop and execute Value Evidence Plan (VEP)
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的 The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
