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
Join the Magic Our Mission At Puratos, we create innovative food solutions for the health and well-being of people everywhere. As the global leader in bakery, patisserie and chocolate ingredients, we help our customers to be
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Job Description レゴ・グループの成長を共に牽引し、多くの子供たちにレゴの楽しさを届けていくためのエキサイティングな挑戦にぜひご参加ください! レゴグループでは Senior Demand Planning Manager を募集しています。 興味のある方は、以下のリンクから採用情報にアクセスください。 皆様の応募を心から楽しみにしております。 Are you detailed and strategic leader who enjoys building a trusted network within both the Markets and Channels & Operations? Bring the demand planning expertise
The Field Account Manager will be responsible for revenue growth within an assigned group of accounts, proactively selling the full range of the BioProcess portfolio, and developing strong customer relationships in order to leverage our position
Wärtsilä is an innovative technology company known for being a forerunner in the Marine and Energy markets. Every day, we – Wärtsilians - put our hearts and minds into turning Wärtsiläs purpose of enabling sustainable societies
About the Company Cybereason is on a mission to reverse the adversary advantage by empowering defenders with ingenuity and technology to end cyber-attacks. We have the technology, and now we are looking to expand our talent!
Job Description: Department Overview Since its establishment in 1997, Rakuten Ichiba has grown to become one of the largest EC sites in Japan, with more than 57,000 stores (as of March 2024) and a large number
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
We are a leading financial services provider committed to making decisions easier and lives better for our customers and colleagues around the world. From our environmental initiatives to our community investments, we lead with values throughout
At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric
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
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
Join the Global Corporate Bank business which manages J.P. Morgans overall relationships with large corporations, financial institutions and public sector organizations globally to solve problems for clients and help them to grow. As a junior corporate
Opportunity At Maersk we value the diversity of our talent and will always strive to recruit the best person for the job-we value diversity in all its forms, including but not limited to: gender, age, nationality,
職種 正社員 職務明細 FENDI Japan MD Assistant Manager / Manager will be responsible for all MD activities related to W’s RTW/FUR and Shoes. スキル・資格 • English skill: TOEIC over 800 in order to communicate with HQ
