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
The Executive Assistant role to the CEO entails providing comprehensive administrative support, managing schedules, communications, and facilitating smooth operations at a strategic level within the organisation. Client Details A dynamic Tokyo-based company is on a mission
About Soracom Soracom was founded in 2015 with a clear vision to build a more connected world. Today, Soracom serves over 20,000 customers worldwide, delivering connectivity for the Internet of Things powered by the speed and
The candidate should have electricity , instrument and DCS engineering capability for project execution RESPONSIBILITIES Contribute to the analysis of information, the specification of the methods, process steps, and the plant, machinery and equipment required to
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract
Lectra Japan Ltd Sales Executive, Fashion INTRODUCTION We invite you to embark on a journey. A technological journey towards the evolution of our society and our industries, powered by Industry 4.0 and supported by Lectra. Software,
Title: AFCAP V Japan BOS: KCS Maintenance - Electrical/HVAC Technician Belong, Connect, Grow, with KBR! Program Summary In support of the U.S. Air Force, KBR provides security, base operations, maintenance, and repair at Kyogamisaki and Shariki
In this position, you will be part of a dynamic and engaged Asia Pacific legal team Maersk’s ambition to be the Global Integrator of Container Logistics. Based in Japan, you will be deeply involved in the
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital
職種 正社員 職務明細 Christian Dior G.K. is looking for Network Development Coordinator. This position reports to Network Development Manager. As Network Development Coordinator, your key mission will be: Support Network development manager with legal check and
Job Title: Immigration Law Paralegal Job Description: We are seeking a bilingual Japanese/English paralegal with 3-5 years of experience in immigration law. As an immigration law paralegal, your responsibilities will include: Assisting attorneys with all aspects
Are you interested in building your further career in Rates Derivative Operations team? As an Operations - Rates Derivatives - Associate within Market Operations, you will mainly A) deal maintenance and drafting of confirmations of Japan based
Great exposure in the JPMorgan Asset Management business. Our Sales teams help our clients build stronger portfolios, for institutions. Our clients face an infinite set of portfolio building challenges. We meet them with a singular focus:
Welcome to Warner Bros. Discovery… the stuff dreams are made of. Who We Are… When we say, “the stuff dreams are made of,” we’re not just referring to the world of wizards, dragons and superheroes, or
Your responsibilities Acquisition of new customers, development of strategic new business, support and securing of our existing customers for our maritime products Preparation of offers in coordination with our headquarters in Germany Conducting contract negotiations and
Job Description: ■Mission Our mission is to support business decision-making from a legal perspective for the sustainable growth of our diverse payment services, including Rakuten Point Card, Rakuten Edy, Rakuten Cash, and Rakuten Pay. The role
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we
What we offer Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital
