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
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
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
* 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
* 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.
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
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
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,
* 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
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
