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 Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Secureworks® (NASDAQ: SCWX) a global cybersecurity leader, enables our customers and partners to outpace and outmaneuver adversaries with more precision, so they can rapidly adapt and respond to market forces to meet their business needs. With
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical
Who we are looking for The successful candidate will be an experienced risk analyst, who thrives in a fast-moving environment and is capable of building credibility with internal members of the Investment Analytics Risk team and
At Gensler, we design for people. We leverage our global perspective and local presence to innovate at every scale. We’re not just designers. We’re tinkerers, craftspeople, visionaries, innovators and thought leaders. Fueled by passion and entrepreneurial
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including
Are you passionate about advancing Microsofts policy agenda and aligning it with the countrys interests? Do you have extensive experience and networks in government, policy, law, communications and/or corporate affairs? Do you want to work for
Microsoft Customer and Partner Solutions (MCAPS) Finance team is hiring an Azure Cloud Solution Area (CSA) Finance Manager to support the Japan area. This position will drive Azure cloud growth in in the Areas through deep
Microsoft is on a mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, a theme of inspiring excellence, and encouraging teams and
Description Come and join us! The Oracle Construction & Engineering Global Oracle Global Industry Unit (GIU). We provide the industry’s most advanced and widely adopted solutions for planning, building and operating assets, partnering with leading organisations
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. We have the vision of a world where each
Who We Are: Ivantis platform makes it possible for employees to stay productive, secure and engaged wherever they are. That starts with us. With headquarters in Utah, offices in London and Paris and nearly 3,200 employees
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
Who we are looking for Seasoned professional with Bachelor’s degree in business or related field, Japanese/English bilingual (written/verbal) and minimum of 8 years of experience in the financial services industry. Why this role is important to
This position is for Japan Business Development role for the Labcorp Japan enterprise organization.Some (not all inclusive) key functions of this role include: support Business Development opportunities, establish product launch processes and activities, support to oversee
PGIM is the diversified asset management business of Prudential Financial, Inc. (NYSE: PRU). With $1.29 trillion in assets under management, and 45 offices spanning 18 countries, PGIM is among the world’s top-14 largest asset managers. Each
[Purpose / 概要] 『お客様がより多くのことを達成できるようにする』私たちの企業ミッションを、Azure Identity サポート チームのエンジニアとして一緒に実現しませんか ? 安心してクラウド サービスをご利用いただくには、私たちが日々サポートしている “認証基盤技術” がライフラインとなります。Microsoft 365 / Office 365 をはじめとする Microsoft のクラウド サービスの認証基盤は、Microsoft Entra ID (Azure Active Directory) が支えています。私たち Azure Identity サポート チームは、この Microsoft Entra ID (Azure Active Directory)