Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food
Job Purpose: His/her mission is to work closely with the business stakeholders and lead the process in defining, answering business questions and implementing innovative solutions arising from business questions that can be answered with analytics/AI. Through doing this, this
Business Overview MACDERMID ENTHONE INDUSTRIAL SOLUTIONS MacDermid Enthone Industrial Solutions is a global supplier of industrial metal and plastic finishing chemistries. We primarily design and manufacture chemical systems that protect and decorate surfaces. Our high-performance functional coatings
EDP Renewables APAC is the main subsidiary of EDP Group, a global leader in the renewable energy sector and one of the world’s largest wind producers. With its headquarters in Singapore, EDP Renewables is the leading
Are you enthusiastic about the opportunity of working for the global leader in renewable energy? Are you a constructive team member and want to be a part of an award-winning team, where the values are high?
Requisition #: 14484 Our Mission: Powering Innovation That Drives Human Advancement When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more
Job Description: ■Mission Supporting the conservation of our corporate value and sustainable growth of our business that provides Rakuten Edy, Rakuten Cash, Rakuten Pay, Rakuten Point Card, etc. By grasping risks across the organization and actively managing and
EDP Renewables APAC is the main subsidiary of EDP Group, a global leader in the renewable energy sector and one of the world’s largest wind producers. With its headquarters in Singapore, EDP Renewables is the leading
LSEG Data and Analytics equips the financial community with access to an open platform that uncovers opportunity and catalyzes change. With a dynamic combination of data, insights, technology, and news from Reuters, our customers can access
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 and
About the job The Red Hat Open Innovation Labs team is looking for an Engagement Lead to join us in Tokyo, Japan. In this role, you will use a variety of modern application development practices, along
AXS Japan GK, of AXS Group, LLC is a subsidiary of AEG and sells millions of tickets every year for 500+ partners across North America, Europe, and Asia, from venues like the O2 in London and
Do you enjoy a role in management? Are you interested in helping to shape a new solution in Japan About our Team Elsevier Health applies innovation, facilitates insights, and helps drive more informed decision-making for our
FP&A Manager Essential Duties and Responsibilities: General accounting tasks in accordance with IFRS (monthly, quarterly and annual accounts) Reporting to the Swiss Head Office via the consolidated financial reporting package Cash management
Are you interested in working with the largest AWS Partner Network (APN) organizations across Asia Pacific as they navigate through some of the most dynamic and disruptive transformation projects in their Enterprise customer organizations histories? Does
Service Commercial APAC Region APC Service APAC Service Sales Offshore APAC Responsibilities You will be overall responsible for the implementation of service sales contract strategies within Vestas. You will have the task to negotiate the Service
Job purpose Responsible for driving commercial success of product in Japan LOC. Member of the Global/LOC cross-functional shaping global strategy and co-creation Key responsibilities Understand global strategy and initiatives, as well as local environment and insights
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的 The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The
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
職務の目的 開発品目の承認申請時の添付文書案作成等： 薬事規制及びGSKポリシーに従い、申請内容に基づく添付文書案作成においてプロジェクトチームをリードする。 CCDSに基づく添付文書の記載事項が承認されるよう、承認審査における添付文書関連照会事項に対する回答作成をリードする。 市販品目の添付文書管理： 薬事規制及びGSKポリシーに従い、最新の情報に基づく添付文書の改訂及び改訂添付文書の公開を滞りなく行う。 添付文書に係るカスタマーからの問い合わせに対して適切に回答する。 アートワーク管理： 必要な薬事Inputを行い、アートワークの変更及び製品への封入切り替えが滞りなく行われるように取り計らう。 市販後薬事： 市販品目のライフサイクルマネジメント（主にCMCの変更管理）に関連し、規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行する。 主な業務内容 承認申請資料（添付文書案含む）の作成・改訂 承認申請時の添付文書案作成における取りまとめ 承認審査時の添付文書関連照会事項に対する回答作成 添付文書改訂相談における当局窓口 添付文書改訂版の校正 添付文書の届出 PMDA 公開サイトの企業ページ管理・必要情報の登録・公開 添付文書に係る外部問合せに対する回答 患者向医薬品ガイドの作成・改訂、当局への改訂相談、公開 市販品目の変更管理に関する薬事業務 業許可管理の業務 当局対応での、承認時期への影響や承認後のグローバルビジネス及び国内での市販製品の供給への影響等を鑑みた方針決定 業界団体・学術団体等を通じた薬制に関する規制調和の推進 ライフサイクルマネジメントに関連する市販後薬事の業務全般におけるタイムライン管理、薬事的課題の把握及び解決策の提案、当局交渉等のマネジメント 必要な条件 医薬品開発、薬事関連業務、変更管理業務あるいは安全性管理業務の経験 海外とメール又は口頭でコミュニケーションができる英語力 当局関係者と交渉するためのコミュニケーション能力 基本的なITスキル（Word, Excel, Power Point等） 向上心があり、変革に対して前向きであること
