At Similarweb, we are revolutionizing the way businesses interact with the digital world by revealing to them everything that happens online. Our unique data and solutions empower thousands of customers globally, including industry giants like Google, eBay,
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） Required Skills:
NVIDIA is looking for an expert Sr. Customer Technical Program Manager to drive the planning and execution of sophisticated, multidisciplinary infrastructure deployment programs with third party companies. We expect you to thrive in an forward-thinking environment
Generative AI is revolutionizing. Ranging from supercomputing, higher education, manufacturing, semiconductors, energy storage, climate science and agriculture. The advent of AI models and tools such as ClimaX, GenSLM, MatterGen, etc are some exemplars of adapting AI for
The Company PayPal has been revolutionizing commerce globally for more than 25 years. Creating innovative experiences that make moving money, selling, and shopping simple, personalized, and secure, PayPal empowers consumers and businesses in approximately 200 markets
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last
Basic purpose of the job: Manage the timely clinical development(CD) and Health Authority(HA) approval of NBI assets for target indications by providing appropriate and robust insights in [TA name] area, based on Japanese TA-specific and healthcare
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, Pharmacovigilance Safety Operations Japan to join our Global Patient Safety team,
１．主な職務における成果責任/ Description of Primary Role & Responsibility A. 市販製品・治験薬の安全性情報（有害事象）収集、評価 / Collection and Assessment of safety information (adverse event information) of marketed/investigation Pfizer products B. グローバル安全性データベースへのデータ入力と管理 / Data entry and management on Global Safety Database C. 日米欧の法規制の遵守、安全性コンプライアンス維持 /
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The MAS roles are hybrid in responsibilities. Specific roles in teams can vary between 80% field with 20% head office activity to 80% head office activity with 20% field
Overview Microsoft Cloud Operations + Innovation (MCO+I) is the team behind the cloud. CO+I is responsible for delivering over 200 Microsoft web portals, Live and Online Services around the world including infrastructure, security and compliance, operations,
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re
WELLINGTON MANAGEMENT Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return and risk objectives of institutional clients in more than
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to
About the Team OpenAI’s User Operations team shepherds our customers’ adoption of AI and ensures that our customers product experience is nothing short of exceptional. We are building the very first post-AGI support team. We resolve
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.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last
About Woven by Toyota Woven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of