Company Description Wolt is a technology company that makes it incredibly easy to discover and get the best restaurants, grocery stores and other local shops delivered to your home or office. Since launching 7 years ago, Wolt has
Company Description Wolt is a technology company that makes it incredibly easy to discover and get the best restaurants, grocery stores and other local shops delivered to your home or office. Since launching 7 years ago, Wolt has
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 望ましい条件
Since its launch in 1993 with a collection of six essential handbags, Kate Spade New York has always been colorful, bold, and optimistic. Today, it is a global lifestyle brand that designs extraordinary things for the everyday, delivering
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Sales Job Details About Salesforce We’re Salesforce, the Customer Company,
Country Director – Japan Are you ready to unleash your potential in a global business that is committed to moving money for the better? How about helping drive successful strategies that will transform the customer and
Bring out your best SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has
Bring out your best SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Sales Job Details About Salesforce We’re Salesforce, the Customer Company,
At Match Group (NASDAQ: MTCH), millions of members use our products every month and our customers go on tens of thousands of dates every single day. Our reach and impact are staggering. We believe that no
Bring out your best SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Marketing & Communications Job Details About Salesforce We’re Salesforce, the
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job Category Sales Job Details About Salesforce We’re Salesforce, the Customer Company,
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves
Your work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market.
