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
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
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
Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題（役割分担等）の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題／問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学（特に製造方法あるいはGMP）・生物学に関する知識がある方 Experience 企業での業務経験のある方（分析、製造、CMC薬事、開発等）（3年以上が望ましい） Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why GSK?
JOB TITLE: FI Settlement Analyst / Associate Title: Associate Location: Tokyo, Japan Regular/Temporary: Employee Hire Impact: Enables support JGB settlement and Japan FICC business as a critical hire. Enables support delivery of OKR for FICC in
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Required Vestas Offshore Service Readiness and Support Department, is part of the overall Offshore Service business in the APAC region, working closely with the Operational Service Team, Sales, Special Projects and Construction. Responsible for the service site setup,
Date Posted: 2024-05-20 Country: Japan Location: NOLEC: 2700-1 Koike, Shibayama-machi, Sanbu-gun, Chiba, 289-1693 JAPAN このページは06919の方専用の登録ページです If you live in a city, chances are we will give you a lift or play a role in keeping you
Job Description: Essential Job Functions Provides service delivery and support in recruitment and employment, new business, employee reassignment, personnel records, employee and/or labor relations, job evaluation, compensation management, benefits administration, organization development, training, AA/EEO, and special projects to
Job Description: Essential Job Functions Provides service delivery and support in recruitment and employment, new business, employee reassignment, personnel records, employee and/or labor relations, job evaluation, compensation management, benefits administration, organization development, training, AA/EEO, and special projects to
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
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
Work Flexibility: Hybrid or Onsite Position summary: Work as part of the Network Services Integration team to deliver network infrastructure projects in line with identified requirements. Work with key stakeholders to ensure that all deliverables are complete
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
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
Position Title Logistics Manager Location Tokyo, Japan Reports to Senior Director, Logistics, APAC Dotted Line Supply Chain Director - Japan Direct Reports 1 x Physical Distribution Operations Senior specialist Scope / Brands Japan Logistics operations ABOUT
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
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious
