Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬（消耗品、機器含む）に係る薬事対応業務 ・製造販売業の維持・管理（更新申請手続き等、3役会議事務局運営など） ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請（承認前調査/定期調査） ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応（被監査部門への監査の実施、報告書作成保管等 1回/年） ・GVP対応（情報収集、当局報告、記録書作成保管等） ・薬事トレーニングの実施管理（年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等） ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験（1年以上） ・薬事規制（特に安全管理業務）に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力（メール対応） ・基本的なPCスキル（Word、Excel（表計算・グラフ作成）、PowerPoint） 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Job Description As the Fashion PR & Communications Specialist, you contribute to added customer value, a strong brand and increased fashion perception by being responsible of Fashion PR & Showroom development and adapting internal communications to the
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
Job Purpose and Impact The Logistics Sourcing Specialist will perform moderately complex activities that ensure efficient transportation of materials and products from origin to destination. In this role, you will participate in the identification and selections of the
Lead regulatory submission process, to contribute expansion of business. Maintain of product registration and related lincenses like MAH or manufacturing site through change control process. Requires basic knowledge of IVD/MD regulation and QMS. Will also cover regulations
DUTIES Responsible for coordinating the delivery of advanced services, post-sales activities, and verification support services. Manages multiple advanced and verification support services for the client. Responsibilities include troubleshooting, the overall planning, organizing, directing, controlling, and delivering
The Group: Morningstar’s Business Development group is responsible for helping our institutional clients strengthen their businesses with the goal of providing better outcomes for investors. The group primarily serves the following client segments: retail banks, private
Job Requisition ID # 24WD79112 Position Overview We are hiring a Technical Support Specialist to join our friendly team of tech enthusiasts assisting customers to get the best out of their Autodesk products. Do you enjoy solving problems
WHO WE ARE LOOKING FOR? Nike Japan is hiring for a Running Brand Specialist to join our Tokyo-based Nike Japan Marketing team. To be successful in this role you must bring ambition to be one of the
Career Growth, Flexibility and Collaboration! Entrust is dedicated to keeping the world moving safely by enabling trusted identities, payments, and data protection around the globe. Headquartered in Minnesota, we offer our colleagues the ability to work
SEE designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient. SEE
About the Role: Grade Level (for internal use): 12 Company Overview: S&P Global is a global leader specializing in cutting-edge Software and Regulatory Compliance solutions for businesses worldwide. Committed to innovation and excellence, we empower organizations
Location: Tokyo, Tokyo, Japan Job ID: R0054655 Date Posted: 2024-06-26 Company Name: HITACHI ENERGY JAPAN, LTD. Profession (Job Category): Sales, Marketing & Product Management Job Schedule: Full time Remote: No Job Description: Mission statement: Responsible for sales
データプラットフォーム統括営業本部では、Data&AIソリューションスペシャリストを募集しております。 金融・サービス企業を中心としたエンタープライズ顧客に対し、新たな顧客体験の創出・業務生産性の課題解決などの経営課題に寄り添う役割を担います。お客様のビジネスを理解し、データの力を最大限に活用する為、マイクロソフトインテリジェントデータプラットフォームを活用し、顧客の変革を支援する役割を担います。ハイタッチのアカウントチーム、カスタマーサクセスチームと連携し、お客様や業界の成功を支援する仲間を募集ししています。 詳細は英語のJDをご覧ください。 Responsibilities Responsibilities Sales Execution Engages in conversations with customers aligned to their industry to introduce how other workloads could enable digital transformation areas that is aligned with the customers industry and turns opportunities
Requisition #: 14704 Our Mission: Powering Innovation That Drives Human Advancement When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more
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
About this role Business Unit Overview: BlackRock Equity Private Markets (“EPM”) is the group of investments of private equity and real estate equity (“EPM Investment Strategies”) at BlackRock. EPM group has many offices in the world
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
Job Description Summary As part of the global Order Management strategy, and aligned with the wider Refinitiv Customer Operations strategy, we are building an Order Management Specialist (OMS) team based in Tokyo, Japan. This Team will provide
Associate Contracts Management Specialist - Tokyo, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000422783 Date Posted: 2024-06-24 Location: JPN - Tokyo, Japan Job Description Qualifications: （Japanese Follows） The Boeing Company is currently seeking an Associate Contract
