JOB DESCRIPTION: Job Summary As a Regional Education Manager, your primary responsibility will be to manage and supervise the educational programs and training performance on electrophysiologic products and related techniques to EP professionals at regional level.
当社では、現在臨床開発モニター（CRA）を募集しています。 施設選定から始まり、モニタリング業務、治験終了業務等、臨床開発業務全般をご担当いただきます。また、治験に関する全てのプロセスが当社のSOPを含む手順書や治験実施計画書、ICH/J－GCP、その他の適用される法規制に沿って、実施、記録、報告されていることを保証することも大切な役割の一つです。 業務内容 ① 治験準備と治験実施計画書の合意 ・症例の集積性や治験実施計画書の内容より、適切な医療機関と治験責任医師を調査 ・医療機関側と治験実施計画書についての説明/合意、治験審査委員会への書類提出、治験開始準備 ・治験前にデンマーク本社スタッフとのミーティング(オンライン/対面)に参加 ② 治験開始時・実施時の施設管理 ・ノボノルディスクのSOPを含む手順書や治験実施計画書、ICH/J-GCP、その他の適用される法規制に沿ったモニタリング関連業務の実施 - 治験審査委員会への治験申請 - 契約 - 治験薬搬入 - 安全性情報の提供 ・被験者のリクルート ・治験データの質の維持を目的としたRisk based monitoring(RBM)の実施 ・担当領域トレーニングへの参加及び施設スタッフとの勉強会 ・医師との関係構築 ・自身のアイディアで様々な問題を解決 ③ 監査・査察 ・海外の監査員からの監査を受ける ・FDA/EMA査察の準備・対応 ・PMDA査察の準備・対応 ④その他 ・デンマーク本社スタッフや各リージョンスタッフと連携しグローバルタスクに参加 ・業界団体 (例EFPIA:欧州製薬団体連合会)の会合に参加 ・ラインマネージャーのサポート ・治験実施計画書のレビュー
General Information Job Advert Title: Platform Engineer, Veeva MyInsights Location: Nihonbashi, Tokyo Division: DigitalX Employment Class: Permanent Description 【Purpose & Scope】 As a Platform Engineer of a team of individuals in a specific area of digital
Career CategoryRegulatory Job Description Group Purpose Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business
Are you passionate about the world of clinical trials? Are you highly motivated by being able to make a difference in improving patients’ lives? The position of Clinical Research Manager provides you the opportunity to work in a
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.
Role Summary The clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region. The clinician medical monitor may be required
Airbnb was born in 2007 when two Hosts welcomed three guests to their San Francisco home, and has since grown to over 4 million Hosts who have welcomed more than 1 billion guest arrivals in almost
Job Description Summary-Defines and drives scientifically sound and business driven project strategy. Reviews, manages, proactively challenges, and controls status of projects operations of the programs and budgets; manages schedules and may prepares status reports. Guides and
Job Description Summary The Medical Advisor is a key partner to medical value through acting as the medical expert for key pharmaceutical products in Japan and also working with international medical affairs team. Job Description Description:
Job Description SummaryThe SSO Associate Clinical Project Manager (aCPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in
Job Description Summary-In line with overall product strategy, the Medical Advisor is responsible for supporting the design, implementation and execution of Medical Affairs plans for assigned Therapy Area, providing scientific information, helping design & organise clinical studies,
Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core
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
【応募要件】 臨床試験の経験は必須、企業経験（3-5年以上）があり開発経験があるMD（日本医師免許）保持者限定 経験によりClinical Science LeadもしくはSr. Clinical Scientistでの採用となる可能性あり Assume overall responsibilities as a regional/country level Development Team leader in the matrix setting to ensure alignment across key stakeholders and promote team work. Drive the development of Clinical Development Plan (CDP)
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.
About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
About us BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
Job Description Summary The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one
