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.
■担当業務（担当者相当のポジション） * 医薬品/医療機器の治験/市販後に関する、以下の安全性情報管理業務。 - 安全性情報の受領・トリアージ・発番・データベース入力・PMDA報告要否の一次評価・QC。 - 症例経過の説明文（日英）・PMDAへの報告書の作成・QC。 - 安全性評価に必要な情報に関する再調査（クエリ）の作成。 - 国内外文献・海外措置情報からの個別症例・研究報告・措置報告の検出。 - 国内外文献・海外措置情報の評価に基づくデータベース入力・QC、PMDAへの報告書の作成・QC。 - 各種報告書のPMDA報告、顧客の提携会社への報告、治験実施施設への報告。 - 症例集積検討、シグナル検出・評価。 - 安全性定期報告案、感染症定期報告案、未知非重篤副作用定期報告案・治験年次報告案の作成・QC・当局報告。 - 治験実施施設向けのラインリストの作成・QC - 顧客へのエスカレーション・調整など - 上記に付随した業務 ■ 担当業務（Workflow Lead（サブリーダ相当）のポジション） 上記担当者業務の日常業務における、進捗・品質・生産性の管理と、トレーニング、エスカレーション対応などのサポート。 ■勤務地 Flexible Style Work適用（在宅ベース） 必要によりオフィス（品川本社/新大阪）に出勤 ■候補者の要件 ■必須 *
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.
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.
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.
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 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。 ~ 〜治験責任医師の要請に応じて治験責任医師主導の試験（IIT）プロセスを促進する
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
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
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
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in 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.
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
Job Title Regulatory Affairs Senior Manager Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven
Job Description Summary ・Hybrid MSL is a new role that performs MSL and also MS. ＜MSL＞ To serve as a liaison to the medical/ scientific community and responsible for establishing, developing, and partnering with Health Care
Medical Manager Location: Japan About the job At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately,challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves,
Job Title Regulatory Affairs Senior Manager - IGTD Job Description Regulatory Affairs Senior Manager Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier
【募集Summary】 RM(Records Management Manager)は、IQVIAにおけるTMF Managementにおいて、Global及び顧客のPOC(Point of Contact)として、ProjectのManagementを実施します。また、臨床チームと協働で、TMFの手順構築、KPIのOversight、各種Issue発生時のCAPA対応等を通して、Inspection Readyな状態を保てるようSupportします。 我々のRecords Management Teamは、IQVIAにおけるTMF managementをGlobalと協働で、centralで実施しております。またIQVIAのＲＭの強みとして、Dx化を促進し、AIも導入、効率的かつ標準的なTMF Managementプロセスを取り入れております。新薬の承認取得に向けたEvidence確保のため、私たちと一緒に働きませんか？ 【業務内容】 ＜Portfolio Lead＞ ● RMのSPOC(Single Point of Contact)として、ProjectのIssue management, escalationを実施する。 ● TMF業務のEAC forecastを提供し、Projectをサポートする。 ● 適切なリソース配置とUtilizationを適切にする。 ● RMとCL/PL間でコミュニケーションをとり、スポンサーおよび試験の状況のupdateを定期的に提供する。 Audits and Inspections時、質疑応答、PLをサポートする。 ● TMFに関するCustomerの要求に関して、CSMGの担当者とコミュニケーションをとる。 ● 必要に応じて、カスタマーのTMF窓口とコミュニケーションをとる。
Medical Manager Location: Japan About the job Responsible for planning and executing medical activities (e.g., evidence generations, publications, medical claim creations, new product development and Health Authorities’ correspondences) and make sure timely and effective execution aligned
Responsible for planning and executing medical activities and make sure timely and effective execution aligned to medical strategy. Reporting to TA Medical head 1. Key accountabilities 1-1. Lead Medical Strategy ■ Lead and monitor the execution of the
