Job Description Main Responsibilities: Support the Quality Assurance activities of the Marketing Authorization Holder as described below: Ensure the implementation of GQP Quality Assurance activities and ensure activities operate within established policies/procedures, global requirements, and all
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
Job Requisition ID # 24WD78669 Position Overview Autodesk is seeking an experienced contract professional who will be responsible for drafting, negotiation, interpretation, and/or administration of contractual documents with some of Autodesks most significant APAC customers. This
Sells a subset of product or services directly or via partners to a large number of named accounts/non-named accounts/geographical territory. Career Level - IC3 Primary job duty is to sell technology software products and related services
Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
Account Manager This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE partner/customer office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way
Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
As a Microsoft Data Center Inventory & Asset Technician (DIAT), you will perform cycle audits, execute incoming/outgoing deliveries, coordinate security escorts for third-party vendors, and document inbound and outbound deliveries as instructed by management. You will
As a Field Marketing Manager for Oracles Cloud Applications, you will be responsible for crafting and executing event marketing plans targeting the ERP and HCM sectors. This role requires a collaborative team player who can work
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
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
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
Acquia empowers the world’s most ambitious brands to create digital customer experiences that matter. With open source Drupal at its core, the Acquia Digital Experience Platform (DXP) enables marketers, developers, and IT operations teams at thousands
Company Description Allegis Global Solutions is founded on a culture that is passionate about transforming the way the world acquires talent by delivering client-focused solutions that make a difference for businesses worldwide. From refining how you
It’s an amazing time to be joining Netflix as we continue to transform entertainment globally. Netflix is the worlds leading internet entertainment service with over 270 million paid memberships in over 190 countries enjoying TV series,
The SUSM ( Start-up Strategy Manager) will develop strategies to ensure the startup plan is executed to minimize time from study allocation to site activation in compliance with CSU/Cluster timeline predictability, company policies and regulations as
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
JOB SUMMARY Responsible for overseeing and coordinating the revenue management functions (pricing, competitive assessments, etc.) and recommending inventory strategy for participating Franchise hotels across all brands in Japan. This includes all room segments (transient, group, and
JOB PURPOSE The successful incumbent is an integral member of the Vaccines GBU ensuring operational smoothness, particularly, but not limited to, the following roles and responsibilities: Acts as focal point between Local/Regional Regulatory, Supply Chain, Sales
