SmartNews is a global leader in redefining information and news discovery, committed to providing users with accurate, timely information and supporting quality journalism. We combine the power of our unique machine-learning technology with the expertise of
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
Company Description Smartkarma connects independent investment research analysts to institutional asset managers, such as sovereign wealth funds, hedge funds, pension funds, boutiques and family offices. Smartkarma’s cloud-based platform leverages the latest in technology to provide a
Company Description Ubisoft’s 19,000 team members, working across more than 40 locations around the world, are bound by a common mission to enrich players’ lives with original and memorable gaming experiences. Their dedication and talent has
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 Ubisoft’s 19,000 team members, working across more than 40 locations around the world, are bound by a common mission to enrich players’ lives with original and memorable gaming experiences. Their dedication and talent has
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
Requisition ID: 3986 Grade: L3 Country: Japan Duty Station: Tokyo Category: Project-funded Professional and higher Type of Job Posting: Internal and External Employment Type: Staff-Full-time Appointment Type: Fixed Term - 200 series Indicative Minimum Net Annual
The Associate Director, reporting to the Japan Brand Practice Lead, will work in close partnership with the APAC/global brand team, and other key Practice and teams in Japan to advance the vision for the Brand Practice
Company Description As a Digital Experience Specialist, You contribute to digital profitable growth in your sales market, playing a critical role in securing the end to-end digital experience of our customers that drives brand perception, sales
Responsibilities TikTok is the leading destination for short-form mobile video. At TikTok, our mission is to inspire creativity and bring joy. TikToks global headquarters are in Los Angeles and Singapore, and its offices include New York,
About ElevenLabs ElevenLabs is a growth-stage startup that has built the most advanced AI voice models and AI voice products (text to speech, audiobooks creation, dubbing, and the voice library). We launched in January 2023 and
Founded in 2013, Voodoo is a tech company that creates mobile games and apps with a mission to entertain the world. Gathering 800 employees, 7 billion downloads, and over 200 million active users, Voodoo is the
HARMAN’s engineers and designers are creative, purposeful and agile. As part of this team, you’ll combine your technical expertise with innovative ideas to help drive cutting-edge solutions in the car, enterprise and connected ecosystem. Every day,
Job Description Summary ・ 開発品の添付文書案の作成 ・ 市販後における添付文書改訂対応 ・ eCTD publishing、申請電子データ提出の日本対応 ・ 承認内容等のデータベース管理 Job Description 先発医薬品の添付文書情報を注意深く監視し、改訂情報等入手した場合には速やかにその内容を自社品添付文書に反映させる（後発医薬品） CDS（Core Data Sheet）更新等の添付文書改訂案件が発生した場合には、安全性部門と協力し適切なタイミングで添付文書改訂を検討・実施する（先発医薬品相当） 開発品において開発薬事等関連部署と協力し、添付文書記載要領に準拠しかつ、先発医薬品の記載内容を参考に添付文書案を作成する 添付文書案作成や市販後の添付文書改訂において、必要に応じて規制当局（MHLW/PMDA）とコミュニケーションを図る 添付文書の記載内容や法定表示事項を参考に、テキストマスターの作成・承認やアートワークレビューを実施する eCTD、申請電子データのPMDA仕様を把握し、日本での提出をリードする 海外のオペレーションチームと連携し、日本仕様のeCTD、申請電子データの編纂をコントロールする 承認書管理データベース等ITインフラの運用管理を行う 【必須要件】 グローバルと英語でコミュニケーションを主体的に実施できる 以下のa)またはｂ）の条件を満たす a)添付文書業務の経験がある a)添付文書関連通知の知識を有する b)eCTD、申請電子データ関連業務の経験を有する 【望ましい資格】薬剤師資格 【求める人材】 プロジェクトに応じてリーダーおよびサポーターとなり、周囲と連携して 業務遂行できる ラーニングアジリティ 計画的に業務の遂行ができる 運用側としてのITリテラシーを所持している
As one of the worlds leading industrial research laboratories, Microsoft Research (MSR) has more than 1,000 researchers and engineers working across the globe. In the past 30 years, Microsoft scientists have not only carried out world-class
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 Who we are Wise was founded in 2011 with a clear mission: Money without borders so people and businesses can send, spend and get paid in any currency, whenever, wherever. Sure, the heart of
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
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
