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
KLDiscovery, a leading global provider of electronic discovery, information governance and data recovery services, is currently seeking a Business Development Manager role for an exciting new opportunity. This position supports the overall recruitment and management of
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
Description Kenvue is currently recruiting a PR Specialist. This position reports into Senior Manager, External Communications, and is based in Tokyo, Japan. Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built
Job Description The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific
Görev Tanımı The Position The Pharmacovigilance Senior Specialist (PV Senior Specialist) will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance organization and reporting into the head of Japan Pharmacovigilance. The PV Senior Specialist is responsible
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
Job Purpose & Key Responsibilities As a Japan Submission manager, you will work not only with Japan submission teams but also with Global Submission Managers closely and as needed with Global Publishers and Global Submission teams
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
【Job Responsibility】 Highly skilled and high potential leader with a proven track record of delivering results in progressive roles to join our team. Have the opportunity to shape and drive a sustainable and high-performing financial accounting
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
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases
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
Career Category Clinical Job Description Responsible for Ensuring that all statistical aspects of documentation pertaining to clinical programs and non-study activities meet required standards and are statistically correct. Influencing study design and analysis, and defending statistical
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.
Job purpose: Responsible for driving commercial success of Botox business in Japan. Member of the GSK/Abbie cross-functional shaping global strategy and co-creation Key responsibilities: Understand global strategy and initiatives, as well as local environment and insights
Job Purpose Responsible for the leadership and operational management of all Quality Assurance, Quality Control, Incoming Materials and External Quality in Japan supply chain, to ensure the continuous supply of medicines & vaccines in line with
Job Description Wise has already pioneered new ways for people to transfer money across borders and currencies. Our customers can also manage their hard-earned money with the world’s first platform to offer true multi-currency banking. The
