* 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.
Responsible for the development and analysis of contractual relationships. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts. 企業情報 * Mega US pharmaceutical * Wide range of pipelines
Reporting to the Hinseki and lead in handling and handling QMS as well as other quality activities. Ensure effective compliance for companys products Client Details * Global medical device company specializing in the oncology area * International
Lead in GQP QA operational activities for the business for company products. Ensure effective compliance, continuous improvement activities, and overall quality processes. Client Details * Global Pharmaceutical company specializing in generics, biosimiilars, APIs, and new products
* 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
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 CMC RA activities for the business in regulatory strategy/maintenance to obtain and maintain regulatory approval. Contribute and support the CMC RA organization both domestically and overseas members Client Details * Global Pharmaceutical company
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
This global pharmaceutical company with a strong reputation for innovation in the field of medicine, it continues to focus on R&D for life-transforming treatments. Its global presence is felt in over 70 countries, specializing in areas
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Planの作成および実行に責任を持ちます。Evidence needsおよびGapを評価し、製品価値を高めるための最も適切な試験計画を組織横断チームにて立案し、提案していきます。 VEO Expert contributes to develop Japan Value Evidence Plan (J-VEP) of the assigned products. VEO Expert plan, implement and deliver high quality, scientifically robust research
