About BHP: At BHP we support our people to grow, learn, develop their skills and reach their potential. With a global portfolio of operations, we offer a diverse and inclusive environment with extraordinary career opportunities. Our
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
Company Description Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative
This is what you will do: The Senior Manager, Project Management is accountable for the generation and maintenance of program timeline for Japan local portion including Advisory Board meeting, internal governance endorsements, PMDA consultation, J-CTN, clinical
Company Description Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative
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,
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
* 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
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
( 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
* At the front line of communication with stakeholders at hospital sites / clinics, youll manage clinical aspects of full-service global trial projects. Your responsibilities will include ensuring timelines, targets, and standards are met for clinical
* 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
* 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
Innovate in the field of chemical drug discovery/process development/manufacturing process by analyzing and using such data through AI. 企業情報 * Big Pharmaceutical * Advanced digital Implementation in the pharma industry 職務内容 * Develop generative models using AI technologies
* 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
