Location Kasumigaseki Building 33rd Floor - 3-2-5 Kasumigaseki, Brookfield Culture Brookfield has a unique and dynamic culture. We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield
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 (VEP)とIntegrated Evidence Plan (IEP)の内容の企画・策定 およびその計画の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 適切な試験やデータベース研究の計画を組織横断チームにて企画・立案・提案し、その実行とEvidenceの公表 までの広い責任と職務をリードしていきます。 また、ワクチン領域においては、定期接種や自治体の予防接種補助金の根拠となるCost Effectivenessモデルの構築やその推定結果をEvidenceとして公表すること、ならびに臨床開発早期の段階にある製品Pipelineに 対して、日本やアジアの疫学的な視点から助言し、承認取得までの臨床開発計画におけるEvidence Gapを 評価し、製品Launchの前後に必要な最適なVEP/IEPを企画・立案・提案することが求められます。 The VEO Expert contributes to plan, develop and execute Value Evidence Plan (VEP)
Position summary The occupational health physician will be expected to provide OH related care to the site J&J employees. Additionally, the physician would need to provide expertise in the prevention, evaluation, and management of conditions that
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
Who we are Are you looking for a dynamic career with excellent advancement potential at a global market leader? If so, consider Gartner, the worlds leading research and advisory company. Gartner delivers the technology-related insight necessary
JOB SUMMARY Responsible for soliciting and managing of reservations sales-related opportunities. Manages and provides training and work assignments to Reservations Sales staff. Actively up-sells each business opportunity to maximize revenue opportunity. Achieves personal and team related
JOB SUMMARY Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer
JOB SUMMARY Develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer and property employees. The position provides the financial expertise to enable
JOB SUMMARY Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer
JOB SUMMARY Provides a high level of property maintenance knowledge. Position has overall responsibility for maintaining the building, grounds and physical plant with particular attention towards safety, security and asset protection. Accountable for managing the budget,
JOB SUMMARY Functions as the leader of the property’s sales department for properties with bookings over 300 peak rooms and significant local catering revenue. Manages the propertys reactive and proactive sales efforts. Provides day to day
JOB SUMMARY Assists in leading the property’s segmented sales effort (e.g., group, transient, association, corporate, etc.) and assists in the implementation of the segment sales strategy and achieving segment revenue goals, property revenue goals and guest
JOB SUMMARY Functions as the leader of the property’s sales department for properties with bookings over 300 peak rooms and significant local catering revenue. Manages the propertys reactive and proactive sales efforts. Provides day to day
JOB SUMMARY Provides a high level of property maintenance knowledge. Position has overall responsibility for maintaining the building, grounds and physical plant with particular attention towards safety, security and asset protection. Accountable for managing the budget,
OVERVIEW Are you tech-savvy? Have a passion for quality? We are looking for Data Raters to work on projects aimed at advancing AI technologies. Join us for a unique chance to kickstart your career in the
Job Description Responsibilities Functionally responsible and accountable for the following areas: Facilities management for 6 facilities in Japan Repairs, maintenance, improvement Access/badge management Office supplies, mail service Office layout, design, planning, seat assignments On-site Contingent Worker
JOB SUMMARY Supports the day-to-day execution of general ledger impacted processes, including support to clients as they work with and understand these processes. Performs accounting functions specifically in the areas of account balancing, ledger reconciliation, reporting
At Accelleron, we go further. Building on the heritage of more than 100 years as ABB Turbocharging, you will join a team of true experts in an exciting international environment that share a commitment to excel,
At MFS, you will find a culture that supports you in doing what you do best. Our employees work together to reach better outcomes, favoring the strongest idea over the strongest individual. We put people first
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
