Company Description AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives
Works directly with GRA Leadership, GRA personnel, as well as PMO and Finance in leading the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and
Job Description Job title: RA Specialist 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 ・プロモーションマテリアルレビューの管理 ・社内および顧客からの要求における資料提供等のサポート業務 ・製品関連証明書対応 *(COA/COO/COS/COI/Animal origin statement/BSE,TSE free statement他) ・海外拠点及および顧客への問合せ対応 ・再生医療等製品材料適格性相談の確認書の提供管理 ・MF申請及び関連対応業務(PMDA及び顧客) 必要とされる資格・経験 ・医療品、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) ・薬機法およびQMS関連規制に関する知識 ・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ISO13485調査対応経験 ・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 *Certification of Analysis/Certification
Objectives of the Position The main coordinator and provider of first level technical support for Japanese & Korean customers Collaborate with the sales organization, regional and global teams to drive business growth Drive innovation and support
RWE Offshore Wind GmbH To start as soon as possible, full time / part time, permanent We are seeking to recruit a professional candidate to become a member of the Legal & Compliance team to work
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
RWE Renewables Japan G.K. To start as soon as possible, full time, permanent About The Role: As Head of Projects & Investments APAC you will be responsible for the financial management and leadership within the development
Job Description IFF aims to help the pharma industry with both every day challenges and future solutions. Armed with essential excipients and vital expertise, our broad portfolio is designed to deliver performance and cost advantages in
Requisition ID 50154 Position Type FT Permanent Recruiter #LI-CST1 Posting Type LI About Kerry Kerry is the worlds leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers
Key Responsibilities Interpret, analyze, and present metrics/KPIs to Management. Drive corrective actions with appropriate groups to improve metrics and address exceptions. Reporting to a country logistics manager and occasionally communicate and present to upper management Lead