At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
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
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
Project Management, Northeast Asia Region APC Construction & Operations APAC Project Management Team Japan Responsibilities • Tender and Project Operation management • Oversee overall tender process, technical/commercial discussion, and submission of Onshore Turbine supply and supervise projects
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
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
Coordinate and lead commercial, engineering and other teams from the beginning of project development through to the Final Investment Decision (FID), with the potential to continue in this role during the later construction stages of the project.
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together,
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
We support peace and prosperity by building connections, understanding and trust between people in the UK and countries worldwide. We work directly with individuals to help them gain the skills, confidence and connections to transform their
BoostDraft is a software engineering company that develops IDE for documents. It was founded by MIT and Stanford grad students, developing an assisted document editor for legal documents. It is a new document editor that employs
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
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
About US (GEMS): ENGIE Global Energy Management & Sales (GEMS) provides energy supply solutions and risk management services to support its clients through their decarbonization journey, while optimizing ENGIE’s assets and contributing to value creation. ENGIE
Appetizer At Maersk, we are determined to put our customers’ needs first. Global Markets are evolving fast, and we aim to connect, protect, and simplify our customers’ supply chain in response to these changes. We are
#WeAreCrowdStrike and our mission is to stop breaches. As a global leader in cybersecurity, our team changed the game. Since our inception, our market leading cloud-native platform has offered unparalleled protection against the most sophisticated cyberattacks.
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for
Position Summary: Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for
About the Role: Grade Level (for internal use): 13 Department overview: Sales specialist is a key function within S&P Global with responsibility for client-facing activity including all aspects of business development for its specialist product line
