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
Company Description The history of Bosch is the history of car evolution. As a top-class automotive equipment supplier, Bosch Corporation supports market expansion/inroads domestically as well as globally. Bosch will continue to pursue forward-looking technologies such
Key objective of the role: Provide an exceptional level of organizational, secretarial, billing and admin support to the lawyers within the department. Also to be recognised throughout the firm as reliable, responsible and trusted employees who
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
Donaldson is committed to solving the world’s most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world.
About Us Automation Anywhere is a leader in AI-powered process automation that puts AI to work across organizations. The company’s Automation Success Platform is powered with specialized AI, generative AI and offers process discovery, RPA, end-to-end
Who we are looking for Transfer Agency Japan offers client service for Asset Managers and Investors located in Japan, liaising with the Transfer Agency teams in State Street Ireland and IFDS Ireland, to provide Investor &
SC Johnson is a fifth-generation family company built on a spirit of adventure and winning the right way. We have been leading with purpose for over 130 years, building top brands such as Raid®, Glade®, Kiwi®,
About Netskope Today, theres more data and users outside the enterprise than inside, causing the network perimeter as we know it to dissolve. We realized a new perimeter was needed, one that is built in the
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
7/7 days and nights roster | FIFO from Perth to the Roy Hill Mine Competitive salary and three annual bonus schemes Benefits include income and life insurances, health, banking, car leasing, airline + travel, IT discounts
As one of the world’s leading asset managers, Invesco is dedicated to helping investors worldwide achieve their financial objectives. By delivering the combined power of our distinctive investment management capabilities, we provide a wide range of
Sales Operations Analyst is a critical and highly visible role to support Japan Sales team rapid business growth. As a member of Revenue Operations team, the role will be responsible for budgeting, planning and analysis activities
International SOS is the world’s leading medical and security services company with over 12,000 employees working in 1,000 locations in 90 countries. International SOS Government Services administers the TRICARE Overseas Program providing high-quality, accessible health care
FY25 New Grads Japan Global Sales_14 This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2-3 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 The Role & Department As MAH QA, implement and promote GQP operations (Release control, manufacturing site control, preparation of necessary documents, quality information control, change control, quality agreement, etc.), continuous improvement Collaboration, instruction, and guidance
Make banking a Fifth Third better® We connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank. GENERAL FUNCTION: The Personal Banker I
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
