Company Description Since we opened our doors in 2009, the world of commerce has evolved immensely, and so has Square. After enabling anyone to take payments and never miss a sale, we saw sellers stymied by
As Lead Development Engineer (Data) for BestX product, VP the ideal candidate will be: Responsible for implementation and delivery of KDB enhancements to the BestX product Exhibit superior skills in modern Agile, Cloud-based, Server side, DB, Development.
企業概要 At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible. At our core, Western Digital is a company of problem solvers.
Job Purpose: His/her mission is to work closely with the business stakeholders and lead the process in defining, answering business questions and implementing innovative solutions arising from business questions that can be answered with analytics/AI. Through
Job Purpose: クローバルメディカルライティング及び国内マトリックスチームと協働し、規制当局に提出する承認申請資料、臨床試験の関連文書等の作成をリードする。関連法規、ガイドライン及び社内規定に従い、戦略的に、正確で科学的な文書を遅滞なく作成し、臨床試験の実施及び承認申請・取得に貢献する。また、効率的な文書作成プロセスを推進する。 Key Accountabilities/Responsibilities: 規制当局に提出する薬事文書の作成のリード:CTDの臨床・臨床薬理パート、対面助言資料、照会事項回答等 臨床試験に関連する文書の作成:治験実施計画書、治験総括報告書等 上記文書の作成におけるストラテジー・key messageの作成、文書作成のファシリテート、解析計画等の検討、スケジュールの作成及びCROマネジメント等 Basic Qualification: Skill CTD臨床パート、治験総括報告書、治験実施計画書等、承認申請や臨床試験に関連する文書の作成能力 社内外の関係者と円滑にコミュニケーションし、マトリックスチームをリードすることができる Global Medical Writing と協業するための英語でのコミュニケーションスキル ロジカルシンキング ダイナミックな変化のある状況下において、柔軟性・自発性をもって問題解決能力を発揮し、目標に向かって推進できる能力 臨床試験に関する基本的知識 生物統計学、薬物動態学に関する基本的知識 薬事規制、ICHガイドライン等に関する基本的知識 基本的なPCスキル(Word、Excel、PDF) Experience 製薬企業又はCROにおけるメディカルライティング業務経験(3年以上) Preferred Qualification: Skill 英文メディカルライティングスキル(治験総括報告書、治験実施計画書等) Experience 承認申請及び審査対応業務の経験(CTD作成、照会事項対応) 臨床開発業務又はそれに準ずる業務経験 複数部署の関係者で構成されるチームをリードした経験 Education/Certification/Language 薬学部または理学系学部卒以上
JOB SUMMARY Functions as the strategic business leader of rooms operations and acts as General Manager in his/her absence. Areas of responsibility include Front Office, , Retail/Gift Shops, Recreation/Fitness Center, Housekeeping and Security/Loss Prevention. Position oversees
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Company Description Are you ready to trade your job for a journey? Become a FlyMate! Passion, excitement & global collaboration are all core to what it means to be a FlyMate. At Flywire, we’re on a mission
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
Cohesity is a leader in AI-powered data security and management. Aided by an extensive ecosystem of partners, Cohesity makes it easy to secure, protect, manage, and get value from data — across the data center, edge, and cloud. Cohesity
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital
Objectives of Position: Independently or partially independently execute R&D projects and topics that support the BASF innovation pipeline to meet the current and future business needs for BASF. Main Areas of Responsibilities and Key Activities: Accelerate
Genesys empowers more than 7,500 organizations in over 100 countries to improve loyalty and business outcomes by creating the best experiences for customers and employees. Through Genesys Cloud, the #1 AI-powered experience orchestration platform, Genesys delivers
Builds strong working relationships, underpinned by trust, credibility and respect with business supervisors Seeks to understand business strategies and supports development and delivery of short and long-term people strategies and agendas Supports the development of HR
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的: 臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。 業務内容: 海外本社の関係部門(特にGlobal SDL)と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。 開発戦略立案:日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う 臨床試験の運営:Study実施の具体的方針決定(各種Study levelでの意思決定)、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理 業務全般及び組織運営にかかわる以下の活動を担う。 各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力(専門的技能・知識等)の向上を担う(組織開発、人財育成 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要要件 Required Skill, Experience, Etc.
JOB SUMMARY Must have Japanese citizenship or Eligible work in Japan permit holder Functions as the strategic business leader of the property’s food and beverage/culinary operation, including Restaurants/Bars, Room Service and Banquets/Catering, where applicable. Position oversees
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
Organization Description Developed in partnership with jeweler and luxury products designer Bulgari, our select Bulgari Hotels & Resorts are located in major cosmopolitan cities and luxury resort destinations. Join our team and help deliver the excitement,