Job Description: Job Description: Department Overview Rakutens Auto Business was established in May 2019 amidst the once-in-a-century transformation of the automotive industry, with a focus on MaaS (Mobility as a Service) and connected cars. Its mission
Leidos is hiring licensed behavioral health professionals to join our Adult Military and Family Life Counseling (MFLC) team to support Atsugi, Japan. Must be available to start on August 1st, 2026 Join the mission to support U.S.
Leidos is hiring licensed behavioral health professionals to join our Child and Youth Behavioral, Military and Family Life Counselor (MFLC) team to support Iwakuni, Japan. Must be available to start by September 4th, 2026 Join the mission
Candidates must live in Japan or Guam. Job Title: Work and Family Life Specialist (Remote) Summary Work and Family Life Specialists (WFLSs) provide one-on-one consultation, education, training, and information and referral services in support of the Work and
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Job Description: Business Overview Rakutens Advertising & Media Company provides a wide range of advertising and marketing services, including digital advertising, research, and influencer business. Our strength lies in our ability to provide end-to-end solutions, from
Job Description SummaryThe Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications,
Job Description: Job Description: Department Overview Auto Business Department is a new business unit launched in anticipation of the once-in-a-century revolution in the automotive industry, including MaaS and connected cars. Our mission is to create a
Job Description SummaryStudy Start-Up Managerは、ノバルティスのプロセス、GCP/ICH、及び国内における規制要件に従って、試験の計画、スタディスタートアップ業務を担い、プロジェクトのスタディスタートアップに関する成果物に対しての責任を負います。 また、国内の開発プロジェクトチーム及びグローバルスタディチームと連携し、担当プロジェクトのスタディスタートアップ業務をリードします。 Job Description Major Accountabilities ・国内の開発プロジェクトチームと連携し、国内のスタディスタートアップ戦略をサポートします。 ・国内の開発プロジェクトチーム及びグローバルスタディチームと協力し、国内のスタディスタートアップのスケジュール及び成果物が達成されるようにします。 ・プロジェクトにおいて、Green Light(治験実施医療機関が開始する準備ができる)まで、タイムリーなスタートアップ業務に説明責任を負います。 ・必要に応じて、IRB/IECへの提出資料の作成、同意説明文書のレビュー及び規制当局への提出、試験の開始業務が予定通りに実施及び完了できることを確認します。 ・IRB/IEC及び該当する場合は規制当局に提出するために、国内の提出資料を作成します。 ・TMF監査への準備を確実にするため、試験開始時の国内のTMF文書のスケジュール、正確性、品質について説明責任を負います。 ・財務基準、現行の規制、ICH/GCP、IRB/IEC、規制当局、SOPの要件を確実に遵守します。 ・ノバルティスの戦略に沿った革新的かつ効率的なプロセスを実行します。 ・Feasibility Manager及びSite Partnership Manager、並びにグローバルスタディマネージャーと連携し、試験の実現可能性をサポートします。 ・既に任命されている場合は、Portfolio Team Lead及びClinical Project Managerと協力して治験実施医療機関の選定をリードします。 ・スタディスタートアップフェーズにおける品質/コンプライアンス問題の主要なコンタクト先としての役割を果たし、必要に応じてエスカレーションします。 ・治験実施医療機関が「Green Light」に備えていることを確認し、初回及びその後の治験薬出荷のための全ての文書が整備されていることを確認します。治験実施医療機関の「Green Light」のレビューと承認に責任を負います。 ・ノバルティスの基準および国内外の規制に従い、スタートアップのスケジュールと品質を確保するために、国内のスタディスタートアップチームの活動を管理し、実施します(必要に応じて是正措置を提案します）。 • 国内のスタディスタートアップチームミーティングの主導/進行役を務め、必要に応じてグローバルスタディミーティングに参加します。 •
Job Description SummaryDrive regulatory submission excellence and early-stage development strategy by authoring high-quality Japanese New Drug Applications and providing pharmacology or toxicology expertise to clinical programs in Japan. Job Description 職務内容 非臨床安全性担当者としてプロジェクトチームに参画しチームメンバーと協働し開発を推進する。 Globalメンバーの一員として，国内外の開発に非臨床安全性担当者として貢献する。 主な役割責任 早期化合物の安全性評価を行いチームへ適切に評価内容を伝える。 承認申請資料を作成し，当局からの照会回答を含む承認申請全般に責任をもつ。
About us Our mission is to reinvent the way people learn, starting with language. Learning a language can change a life by opening doors to new cultures, careers, and communities. Two billion people around the world are
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Onto Innovation is a leader in process control, combining global scale with an expanded portfolio of leading-edge technologies that include: 3D metrology spanning the chip from nanometer-scale transistors to micron-level die-interconnects; macro defect inspection of wafers
Job Description: Department Overview Rakuten Rakuma was established in 2012 during the dawn of flea market apps. (Fril was launched in 2012 and merged with the former Rakuma in 2018.) Over ten years have passed since
Job Description: Business Overview The Commerce Company provides a wide range of services centered on internet-based shopping, lifestyle, and leisure offerings, all designed to make daily life more enjoyable and convenient. Among these, Rakuten Ichiba stands as
Job Description: Department Overview EC Consulting Department is a frontline division that acts as a partner to merchants on “Rakuten Ichiba,” providing comprehensive support - from strategic planning to product development - to help them maximize
Job Description: Business Overview Rakuten Group provides more than 70 services in a wide range of fields, including e-commerce, travel, digital content, and other Internet services in Japan and overseas, as well as financial services such
Job Description: Business Overview Rakuten Group, headquartered in Japan, serves approximately 100 million users in Japan and over 1 billion globally. We offer more than 70 services across various fields, including e-commerce, payment services, financial services,
Job Description: Business Overview Rakuten Group, headquartered in Japan, serves approximately 100 million users in Japan and over 1 billion globally. We offer more than 70 services across various fields, including e-commerce, payment services, financial services,
Job Description: Department Overview Have you ever felt happy about earning a lot of points? The Rakuten Super DEAL service is one of the largest point-back services in Rakuten Group, Inc., which has over 100 million