Wärtsilä Energy leads the transition towards a 100% renewable energy future. We help our partners to accelerate their decarbonisation journeys through our market-leading technologies and power system modelling expertise. These cover decarbonisation services, future-fuel enabled balancing
Minimum qualifications: JD, LL.B., equivalent degree, or equivalent practical experience. 3 years of relevant attorney level work experience, in-house experience. Admitted to the bar and in good standing or otherwise authorized to practice law (e.g., have
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing
WPP is the trusted growth partner for the world’s leading brands. We unite cutting-edge media intelligence and data solutions, world-class creativity, next-generation production, transformative enterprise solutions and expert strategic counsel in a single company – powered
The Trade Desk is a global technology company and the world’s leading independent platform for digital advertising, with nearly 4,000 employees across more than 30 offices. Our technology helps advertisers reach the right audiences across the
Overview 3-4日のリモート勤務可能 QMS関連のコンサルティング業務を担当する機会があります。 To understand requirements from QMS/PMD Act., and support QA Senior Manager who drive forward proper Quality Management system operation and maintenance Create documents of QMS,FMR and MAH license related application under supervision of
Since 1998, weve been on a mission to reshape how players interact with their favorite games, growing into a global team of over 12,000 professionals spread across 70+ studios in 26 countries. We are always there
About Airwallex Airwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software, we empower over 250,000 businesses worldwide – including Brex, Navan, Qantas, SHEIN
About the Team The GTM Partnerships team is responsible for building a global, best in class, partner ecosystem that makes our customers successful, supports the companys mission of reaching AGI, and impacts the revenue growth of
With 1,000+ intelligence professionals serving over 1,900 clients worldwide, Recorded Future is the world’s most advanced, and largest, intelligence company! At Recorded Future, we built the world’s largest and most advanced threat intelligence platform - Enabling
Company Description It all started when engineer Fred Luddy wrote code that automated a tedious task for his coworker, Phyllis. She cried tears of joy. That moment inspired Fred to build a company that could do
Account Executive - Communications, Energy & Utilities Hybrid | Tokyo We’re a leader in data and AI. Through our software and services, we inspire customers around the world to transform data into intelligence – and questions
Menlo Security is the leader in Browser Security for human and agentic workforces. Our mission is to enable humans and agents to connect, communicate, and collaborate securely, without compromise. The Menlo Browser Security Platform protects organizations
Company Overview Offering a complete ecosystem of maritime services, including broking, finance, port services and research, Clarksons is at the heart of global shipping. Our unrivalled reach, expertise, and depth of experience, combined with leading research,
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Manager, CMC Regulatory Affairs to join our Regulatory Affairs team, supporting
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Administrative Coordinator to join our Regulatory Affairs team, supporting our Japan Regulatory
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager Regulatory Strategy Oncology & Japan Affairs to join our Regulatory
Job Description: Business Overview Rakuten Group provides over 70 services across a wide range of domains both in Japan and internationally, including internet services such as e-commerce, travel, and digital content; fintech (financial) services including credit
Job Description 【募集メッセージ】 オンコロジークリニカルサイエンス（OCS）では、がん治療を変えうる画期的な新薬の世界同時開発を様々な部署と連携して進めています。会社の重点領域の1つであるオンコロジー領域において、開発プロジェクトへの貢献を通じた様々な経験の中で、専門知識の習得、サイエンスレベルやコミュニケーションスキルの向上、論理的思考力の強化など、人財のさらなる成長を図っていきます。Oncology Clinical Science部のVisionとして「様々な知恵と経験を結びつけてOncology Clinical Science One Teamとしての新たな価値を創造し、Oncology開発チームの要としてステークホルダーに貢献できる存在となること」を掲げています。臨床試験の成功に向けた重要な任務を担うとても「やりがい」のある役割ですし、社員同士が気軽に相談・協力しやすい環境も整っています。是非、積極的なチャレンジをお待ちしています。 【期待される役割】 開発責任者（Japan Clinical Director）をはじめとする開発関連部門（米国本社を含む）と連携し、臨床試験チームの主要メンバーとして臨床試験を遂行し、当局との開発戦略の相談や承認申請の業務の一部を担う。 【業務内容】 開発戦略策定の補佐 （早期及び後期開発計画書への日本の臨床試験計画のインプット） 開発戦略に基づいた機構相談の立案や資料作成のサポート、及び照会事項に対する回答作成 治験実施計画書の立案及び翻訳・作成 o ローカル試験（試験骨子から作成） o グローバル試験（主に翻訳）：米国本社との日本固有の要件等に関する交渉を含む 同意説明文書（会社案）の作成 治験実施計画書に関連する資料（症例報告書、関連手順書等）の作成サポート及びレビュー 治験届（CTN）の添付書類作成とPMDAからの照会事項対応 症例の適格性確認、治験データに対するメディカルモニタリング、重篤な副作用（SAE）対応 治験総括報告書及び承認申請資料（CTD）臨床パートの作成 （メディカルライターと協働）及びレビュー 承認申請後の照会事項に対する回答作成、適合性調査対応 学会発表、論文作成及びそれらのサポート 【必須条件（望ましい条件）】 医薬品臨床開発業務の経験（3年以上のオンコロジー経験あれば尚可） 治験実施計画書の作成経験 社内（国内・外）関連部門及び外部専門医との密接な協働作業のためのコミュニケーションスキル 英語力（TOEICスコア730点以上目安）
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.