Be part of a critical member in the RA organization. Lead in RA development/strategy activities to obtain product approval for various unmet medical needs. Client Details * Global leading pharmaceutical business specialising in womens health * With
■ 職務内容 / Job Description Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in
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
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
職務 概要 Position Summary : 富士 New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering )は以下職務を行う。 The New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering ) for as follow l 富士工場新製品導入のガバナンス,プロジェクトの実施 Execute governance and project for Fuji
Job Description Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Technical Consultant OneSource tax solution clients in Japan report various technical and non-technical issues, which requires successful resolution in a timely manner, minimizing/avoiding customer impact. This particular role focus on technical issues mainly, taking lead in
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
■ 職務内容 / Job Description Lead Safety Information Management Group to manage pharmacovigilance activities incl. collecting, evaluating, and submitting safety information to relevant parties (e.g. PMDA, AZ global Patient Safety, licensing partners) and lead communication (incl.
The statistical analyst provides strong leadership in the process of drug development, by preparing CDISC complied databases, statistical summary table/figures in accordance with a schedule. 企業情報 * 外資製薬会社 * イノベーション:研究開発への投資を通じて、新しい医薬品や治療法の開発に取り組んでおり、疾患の治療と予防に貢献しています。 職務内容 * Provide strong statistical leadership in the
* Lead and project management of the following studies: - CSS (Company-led research) - IIS (Doctor-led research) - Collaborative study - Including oversight of external CRO Client Details * Leading global CRO business, with rich project
Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. Actively contributing to process improvement and site management, you will train
A leading global pharmaceutical company seeks a talented individual to join their team as a Finance Business Partner. In this strategic role, youll play a pivotal role in supporting various business units, providing financial analysis, insights,
* Lead and manage a team of biostatisticians and data managers to ensure the delivery of high-quality and timely statistical analysis plans, data management plans, and data analyses for clinical trials. Client Details * Our client
* This position will be responsible for managing assigned clinical studies globally and locally, overseeing study activities, budgets, timelines, and vendor relationships. * The role involves leading a multifunctional team, ensuring adherence to regulatory requirements, managing
* The Safety Management Officer will oversee all safety management and pharmacovigilance (PV) activities in Japan. * This role involves ensuring compliance with local regulations, managing risk, and maintaining high standards of safety for all products.
Take lead in medical writing activities in authoring clinical/regulatory documents as well as submission requirements to obtain product approval. Align with global business strategies for local requirements Client Details * One of the top global biopharmaceutical
Take lead in quality activities to ensure effective compliance. Manage QMS and other quality claims. Client Details * Global pharmaceutical company specializing in innovative treatment for oncology, urology, and auto-immune areas. * Rich development pipeline for new
Job Description Summary -Lead the country Franchise Medical Team, develop the Franchise Medical Strategy and executes it through and operational Medical Plan. Coach and develop team members as well as represent Medical in country Franchise Leadership
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be part