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
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
#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.
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
Get to know Okta Okta is The World’s Identity Company. We free everyone to safely use any technology—anywhere, on any device or app. Our Workforce and Customer Identity Clouds enable secure yet flexible access, authentication, and automation
Koala is a high growth ecommerce startup originating in Sydney, Australia. We provide furniture for the digital age, and have become well known in Australia and Japan because of our approach to marketing & retail which
As an Amazon Field Engineer, you will provide full life-cycle support to AWS Data Centers from design inception through site improvement and maintenance. You will be the ‘go to’ engineering resource for your region when technical
Koala is a high growth ecommerce startup originating in Sydney, Australia. We provide furniture for the digital age, and have become well known in Australia and Japan because of our approach to marketing & retail which
Job Description Prepare documents and report regularly with client management people, business and IT departments on project planning, quality, and progress. Lead Japanese team members and offshore development members, directing their work and ensuring that it gets done. Understand
Company Description LinkedIn is the world’s largest professional network, built to create economic opportunity for every member of the global workforce. Our products help people make powerful connections, discover exciting opportunities, build necessary skills, and gain
Wrike is the most powerful work management platform. Built for teams and organizations looking to collaborate, create, and exceed every day, Wrike brings everyone and all work into a single place to remove complexity, increase productivity,
Company Description We are Wix’s Enterprise team. We’re a new team focused on becoming the go-to solution for large companies looking to maximize their potential online. Through a combination of forward-thinking design language and a smart,
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
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. We were founded in 2014 and joined
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
