At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring
Career Category Regulatory Job Description Group Purpose Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise for drug development; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical
Field Service Engineer, Japan As a Field Service Engineer you will perform assembly, disassembly, and repair work on analytical laboratory instruments and equipment and effectively and safely utilise test equipment, hand tools and power tools as
職務の目的および主な業務内容 Quality Management Systemの中で、主に以下の業務を担う。 ・文書管理 (工場内の標準書及びGxP文書の管理) ・Regulatory関連（当局とのコミュニケーション、変更案件の薬事影響評価、本社CMCとの連携、当局監査のマネジメント） ・自己点検、課内点検のマネジメント ・ワクチンの国家検定 ・GSK StandardであるQuality Management System（GSKのstandard）のサイトへの導入 ・GxPにかかわる教育管理 上記の業務を実施しながら、生産現場を含むQA以外の部、Functionとも連携をとり、改善活動を実施していく。 上記業務のほかに、コンプライアンス課では、品質の取り決め書の作成、製品及び原料の品質QC実験用の規格基準設定、製品に使用される資材の規格設定及び取り決め書（品質契約書）作成変更管理、サプライヤーコントロール などを主とするGroupがあり、２つのGroupにてお互い協力しながら、業務を遂行している。よって、QMSの多岐にわたる業務にかかわることができ、将来のQA内外へのキャリアプランやDevelopmentにプラスとなる業務を担うことができる。業務の内容によっては、グローバルチームや他のサイトとのCommunicationをとることがある。 必要な条件 スキル ・GMPの知識 QMS概論の知識 ・英語（技術文書の読解、メールでのコミュニケーション、電話会議参加） ・PC skill（Word, Excel, PowerPoint） ・基礎的な問題解決能力 ・工場内外において相互協力、協調して作業を行う能力（コミュニケーション能力） 経験 ・製造業での品質業務経験 ・当局監査対応 学位/資格 ・薬学、化学、工学等の理系分野の学士以上 望ましい条件 スキル ・医薬品の生産工程、関連する原資材に関する必要とされる知識 ・安全衛生の理解
As a post-trade sales associate, you will be part a leading multi-asset class and international clearing house, serving major international exchanges and platforms as well as a range of over-the-counter markets globally and across Asia Pacific.
Application Deadline: 06/27/2024 Address: 12545 Central Ave. Job Family Group: Retail Banking Sales & Service Inland Empire. Bi-lingual, Spanish Speaking Candidates Preferred Cultivates, builds, and manages relationships with a third-party network of referral sources to build
職種 フルタイム(契約) 職務明細 EssilorLuxottica is a leader in the design, manufacture and distribution of fashion, luxury and sports eyewear. Its portfolio includes proprietary brands such as Ray-Ban, Oakley, Oliver Peoples and Alain Mikli, as well as
Be part of a top 10 Global CRO thats entering the Japan market as a first member. Lead in RA activities to submit clinical trial documents to obtain approval. Client Details * Top 10 global CRO
The Senior Clinical Research Specialist is responsible for leading and managing clinical trials and post-market studies in compliance with regulatory requirements. This role involves overseeing trial operations, coordinating with internal and external stakeholders, and ensuring data integrity
Lead the accounting team by overseeing the financial reporting, budgeting, and accounting operations within the company. Communicate not only domestically, but globally with the other offices in APAC and the HQ to ensure compliance with regulatory requirements
Be part of a top 10 Global CRO thats entering the Japan market as a first member. Lead in RA activities to submit clinical trial documents to obtain approval. Client Details * Top 10 global CRO
As Head of Pharmacovigilance, the role entails leading safety monitoring efforts for pharmaceutical products, ensuring regulatory compliance, and managing a team of professionals in these responsibilities. Client Details The organization focuses on providing essential pharmaceutical services, particularly
Build and sustain relationships with project owners, central and local administrations, real estate and project brokers, and construction partners to actively engage in identifying and originating new projects in strategically targeted marine areas. Client Details A
Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。 The Role The Marketing Communication of Genmab KK (Japan) will be primarily responsible for (but not limited to) creating promotional materials. This includes official documents such as interview forms and patient guides, as well as
If you have what it takes to become part of the Vistra family and would like to start a promising career with a global leader, take a look at the exciting employment opportunities that are currently
Planate Management Group (PMG) is a Service-Disabled Veteran-Owned Small Business (SDVOSB) headquartered in Alexandria, Virginia, and Orlando, Florida USA with technical support centers in South East Asia and East Africa, that provide program management and facilities
Job Description Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system.
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
