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
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,
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
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
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: Provide sound, efficient and effective legal services and advice to the business units and support functions in Japan, including: · Reviewing, drafting, advising on and negotiating various agreements; · Ensuring timely and effective provision of
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
Job Responsibilities Manages legal business matters pertaining to the organization. Provides a variety of general corporate and commercial legal services to a number of in-house clients. Acts as advisor on legal issues involving the organization’s government
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
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
Seeking a Subject Matter Expert on regional Extended Workforce (EW) Operations via Vendor Management System (VMS). Key Responsibilities EW Request Lifecycle Management through VMS Intake of EW request from stakeholders: collaborate with CBM and GSP Country
Job Requisition ID # 24WD78669 Position Overview Autodesk is seeking an experienced contract professional who will be responsible for drafting, negotiation, interpretation, and/or administration of contractual documents with some of Autodesks most significant APAC customers. This role will
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
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
【仕事内容】 ロンドンに本社を構える市場調査会社「Mintel Group」の日本法人である弊社にて、 採用をメインとした人事業務と、そのほか入退社手続きなど、一部総務関係などをお任せいたします。 採用プロセス 選考、入社、研修、業績評価、人事管理、組織開発、文化、福利厚生、従業員関係、退職 ]採用に関して戦略的な中長期計画の策定と実施 APACや本国との定期的な人事業務に関するレポート 一部総務業務（入退社書類の手続きなど） ※労務については外部提携先と連携して行います。 【求める経験・スキル】 [必須] ■採用業務：5~7年以上（一人で自立して行える方） ■ビジネスレベルの英語力（APACとの連携など業務上必ず使用いたします） ■面接、採用プロセス管理の経験 [歓迎] 総務や労務のご経験 From fast answers to deep insights, Mintel has provided research and intelligence solutions to consumer-focused businesses for more than
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
