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?
At World Kinect, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment,
Figma is growing our team of passionate people on a mission to make design accessible to all. Born on the Web, Figma helps entire product teams brainstorm, design and build better products — from start to finish. Whether
Purpose & Overall Relevance for the Organization: Provide a high level of administrative support to Japan HR Vice President and Japan Finance Vice President and his/her team to ensure efficient management and running of the function on
AI Sales, Business Development Executive At Dell Technologies, we create the extraordinary. Our AI Sales Biz Dev Executives are the experts who sell AI innovation to the world. Responsible for AI business growth & sales enablement, they get
Figma is growing our team of passionate people on a mission to make design accessible to all. Born on the Web, Figma helps entire product teams brainstorm, design and build better products — from start to finish. Whether
If you are passionate, and have strong desire to set and achieve challenging goals, you have found the right team. As a Vice President/Executive Director within the Corporate Client Banking & Specialized Industries (CCBSI) team, you will be responsible
Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our
Position Summary: Customer Support Executive is the entry point for customers in Japan seeking application and content support for Trading, Risk Management, Media and Wealth Management customers in Japan. The role is responsible for delivering world class
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
Position Summary: Customer Support Executive is the entry point for customers in Japan seeking application and content support for Trading, Risk Management, Media and Wealth Management customers in Japan. The role is responsible for delivering world class
Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our
Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our
Account Executive - Enterprise - Japan Rapid7 is seeking a curious, customer centric and target driven Account Executive to join our Japan sales team and be responsible for all aspects of new customer acquisition across the territory, contributing to
At World Kinect, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment,
Hiring Manager: Hiroaki Mizutani Talent Acquisition Advisor: Tomo Yamane Job Code Level: SGP4 Refer Your Friends! Skills & Experience Summary 日本における「対象企業」とのビジネスにおいて全責任を持ち、OPENTEXT のサービスの価値をより深く浸透させ、新規顧客開拓や既存顧客への契約拡張を実施、拡販、グローバルアカウントモデルで世界中の「対象企業」グループとのビジネスを拡大する。 「対象企業」のニーズに応えられるよう東京本社を拠点とした営業活動を行う。事業プランを策定し、実行、実現する。 営業、マーケティング、デリバリ、サポートのあらゆる面から「対象企業」ビジネス戦略をリードする。 入社後３ヶ月以内に初期の研修を終え、サービスの内容と技術的知識を修得し、会社の方針に沿って自律的な活動を行う。 日本における最大顧客である「対象企業」を責任者となる為、Global Mgmt. Team の注目度も一際高い。 「対象企業」のビジネスを広範囲に把握し、「対象企業」の事業展開に大きく寄与する提案活動をする為の、戦略立案スキル。 OPENTEXT のサービスの内容や技術的優位性を、ビジネス面、技術面双方から説明できるスキル。 「対象企業」との良好な人間関係樹立、維持する為のスキル、他チームとの連携等の為のマネジメント、コミュニケーションスキル Interpersonal/Team Skills Required パートナーである SC
Our Equity Research team is fast-paced, demanding and intellectually stimulating! As a Vice President in Equity Research team, you’ll primary take responsibilities for industry analysis and company-specific coverage within the sector, with the opportunity to take on lead
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we
About Glean We’re on a mission to make knowledge work faster and more humane. We believe that AI will fundamentally transform how people work. In the future, everyone will work in tandem with expert AI assistants
About Glean We’re on a mission to make knowledge work faster and more humane. We believe that AI will fundamentally transform how people work. In the future, everyone will work in tandem with expert AI assistants
