■ 職務内容 / Job Description Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as medical writer. MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the
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
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
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
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
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
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
Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit) staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures
Are you ready to unleash your full potential? We’re looking for people who are passionate about payments to chart Worldpay’s path to being the largest and most-loved payments company in the world. About the team Our
Job Description The Goldman Sachs Group, Inc. is a leading global investment banking, securities and investment management firm that provides a wide range of financial services to a substantial and diversified client base that includes corporations,
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 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
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
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
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
About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The
Product Manager – Quantile (Post Trade Solutions) Quantile brings a proven, unique blend of business, quantitative and technology skills to the industry, to provide post-trade risk reduction services to major derivative market participants. Our focus is
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
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.
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
