ING Bank ING Bank covers Wholesale and Retail Banking in Asia Pacific. Our Wholesale Banking business is present and active in 11 major economies in the Asia Pacific, namely Australia, China, Hong Kong SAR, India, Indonesia,
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?
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
Requisition ID: 200162 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. What your role will be. Customer Relations Representative As a member of the Dealer Finance Centre (DFC) Team
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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
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
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Plan (VEP)とIntegrated Evidence Plan (IEP)の内容の企画・策定 およびその計画の実行に責任を持ちます。Evidence NeedsおよびGapを評価し、製品価値を高めるための最も 適切な試験やデータベース研究の計画を組織横断チームにて企画・立案・提案し、その実行とEvidenceの公表 までの広い責任と職務をリードしていきます。 また、ワクチン領域においては、定期接種や自治体の予防接種補助金の根拠となるCost Effectivenessモデルの構築やその推定結果をEvidenceとして公表すること、ならびに臨床開発早期の段階にある製品Pipelineに 対して、日本やアジアの疫学的な視点から助言し、承認取得までの臨床開発計画におけるEvidence Gapを 評価し、製品Launchの前後に必要な最適なVEP/IEPを企画・立案・提案することが求められます。 The VEO Expert contributes to plan, develop and execute Value Evidence Plan (VEP)
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Planの作成および実行に責任を持ちます。Evidence needsおよびGapを評価し、製品価値を高めるための最も適切な試験計画を組織横断チームにて立案し、提案していきます。 VEO Expert contributes to develop Japan Value Evidence Plan (J-VEP) of the assigned products. VEO Expert plan, implement and deliver high quality, scientifically robust research
About the role: We are searching for an exceptional person to take a position as a Sr. Sales Director for our growing Enterprise sales team in Japan and help Brightcove achieve breakout growth. This person must
APPLY NOW TO ENTER THE POOL OF CANDIDATES FOR OUR ASSESSMENT CENTRES, WHICH WILL RUN FROM JANUARY 2024 TO JUNE 2024. PLEASE NOTE THAT APPLICATIONS MAY CLOSE EARLIER IF OUR TARGET REQUIREMENTS ARE MET. Hours: Full
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
We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace
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
Summary Posted: May 29, 2024 Role Number: 200512819 The people here at Apple don’t just build products — they craft the kind of wonder that’s revolutionized entire industries. It’s the diversity of those people and their
Technical Support Engineer – Optical Telecoms & DWDM Melbourne, Australia Home & Office Hybrid Act as DWDM system engineer to test already designed and build up DWDM rings in a test environment with the following activities:
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
