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 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
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
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,
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
Who Are We? HoYoverse is committed to providing immersive virtual world experiences to players around the world. We have brought fans popular games including Genshin Impact, Honkai: Star Rail, Honkai Impact 3rd, Tears of Themis, and
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
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
Responsibilities: About Tencent Games Tencent Games was launched in 2003 and has since grown into a leading global platform for game development, publishing, and operations. We are dedicated to providing high-quality interactive entertainment experiences to players and
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Joining Razer will place you on a global mission to revolutionize the way the world games. Razer is a place to do great work, offering you the opportunity to make an impact globally while working across
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
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
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
Mujin develops MujinController, a platform that leverages a real-time digital twin and provides a suite of perception, planning, and control algorithms to digitize the physical world. Powered by our unique approach to robotics Machine Intelligence (MujinMI),
Job Title: Director Healthcare, Japan Location: Tokyo, Japan About Springer Healthcare Springer Healthcare is a leading global medical communications and education provider. Working in partnership with pharmaceutical companies and key opinion leaders, Springer Healthcare develop bespoke
Who Are We? HoYoverse is committed to providing immersive virtual world experiences to players around the world. We have brought fans popular games including Genshin Impact, Honkai: Star Rail, Honkai Impact 3rd, Tears of Themis, and
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
Who Are We? HoYoverse is committed to providing immersive virtual world experiences to players around the world. We have brought fans popular games including Genshin Impact, Honkai: Star Rail, Honkai Impact 3rd, Tears of Themis, and
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
