+ · 住友重機械グループでは、新規医療機器の開発・製造・薬事承認に向けたプロジェクトを推進しています。 · その中で、薬事申請業務は承認取得に不可欠なプロセスであり、専門性を持つ人材の強化が急務となっています。 · 今回のポジションは、こうした新プロジェクトにおける薬事申請業務を専任で担当し、承認取得に向けたプロセスを推進する役割です。 · +1.国内医療機器の薬事申請業務(承認取得に向けた資料作成•提出) · +2.PMDAとの折衝•問い合わせ対応 · +3.社内関係部門(設計,品質保証,製造)との調整•情報共有 · ...

Build a career with confidence at Carrier Global Corporation, a global leader in intelligent climate and energy solutions. We are committed to creating solutions that matter for people and our planet. · Carrier Global Corporation is committed to creating solutions that matter for ...

We're committed to bringing safety, quality, and customer focus to the business of advanced ceramics manufacturing. · It's exciting to work for a company that makes the world measurably better. · English communication ability (email/conversation) · &c3&a93 years or more o ...

This position is responsible for conducting scientific evaluations of drug characteristics from a non-clinical perspective, developing domestic development strategies, and preparing materials to meet regulatory requirements. It also contributes to the implementation and approval ...

This position plays a pivotal role at one of the world's leading biopharmaceutical contract manufacturing business organizations contributing directly to shaping the future of biotechnology and biopharmaceutical industry as Director of Business Development & Key Account Managemen ...

Nonclinica Project Specialist job description and requirements in Japan. · ...

We are seeking a Quality Assurance/Control Specialist to join our team at Boehringer Ingelheim Corporate. As a key member of our quality assurance team, you will play a crucial role in ensuring high-quality products reach customers safely and effectively. · You will be responsibl ...

This role plays a pivotal part at one of the world's leading biopharmaceutical contract manufacturing business organizations contributing directly to shaping future biotechnology. · Execute contract manufacturing business strategy with focus on mammalian & microbial technologies ...

We are looking for an export trade sales professional to join our team. As an export trade salesperson, you will be responsible for selling measuring instruments to customers in various countries. · ...

We're looking for a Principal Specialist to join our QARA team in Tokyo. As a General Marketing Supervisor under the PMD Act, you'll ensure compliance with all applicable QMS and GVP requirements. · ...

We sell measuring instruments to customers mainly in Asian countries such as China,Korea,Thailand,and Vietnam. · We handle telephone,fax,and e-mail,but we will teach you how to use them.Record the contents of orders and shipping procedures in the sales management system.In additi ...

Provides support by addressing customer requests inquiries and/or questions through email phone or live chat. · ...

Provides support by addressing customer requests inquiries and/or questions through email phone or live chat. · ...

The role of Data Center Customer Operations Engineer III at Equinix involves maintaining and evolving critical infrastructure that powers the digital world. · Maintenance of physical network infrastructure · Ongoing operations in data centers · ...

A Pharmaceutical Information Specialist is needed to provide high-quality services for stakeholders in the neuroscience therapeutic area. The successful candidate will be responsible for market analysis, sales growth strategies, resource utilization, customer engagement, · and co ...

+Job summary · The GXP Quality Assurance Specialist will oversee all aspects of quality assurance in accordance with regulatory requirements. · +ResponsibilitiesSUPervise document control defined in GQP Ordinance (SOP Quality Standard Codes) · ...

The main responsibilities of this role include ensuring compliance with GQP Ordinance regulations by creating SOPs for drug products. · ...

Perform GXP activities according to GQP/GMP Ministerial Ordinance and GDP guideline. · SUPVISE DOCUMENT CONTROL DEFINED IN GQP ORDINANCE · ...

Assure proper manufacturing control and quality control in accordance with GQP/GMP/GDP regulations. · Investigate and analyze quality problems of products before shipping and take actions for improvement to manufacturers. · Apropriately manage deviation controls, change control m ...

This is a Medical Information Specialist role for the Parkinson Disease Area in Osaka or Kanazawa. The successful candidate will provide high-quality services to stakeholders in the region, including sales growth and market analysis. · ...

This position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement proj ...