When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Role Summary The clinician contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region. The clinician may be required to design a
Sr CRA II Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change
Sr CRA I Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change
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)
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
We Are Synopsys is the leader in engineering solutions from silicon to systems, enabling customers to rapidly innovate AI-powered products. We deliver industry-leading silicon design, IP, simulation and analysis solutions, and design services. We partner closely
Overview About the Role & Team In this position, we are looking for an analyst to lead Japan Digital Spending market research and to support Tech buyers’ research. The analyst has a responsible for CIS program,
Overview About the Role & Team In this position, we are looking for an analyst to lead application software market research, especially in mid-tier vendors area. The analyst has an assist for “Worldwide Semiannual Software Tracker”
REQ ID: FEQ427R347 Location: Tokyo, Japan At Databricks, our core values are at the heart of everything we do; a culture of proactiveness and a customer-centric mindset guide us to build a unified platform that makes
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put
Lumen is the trusted network for the AI‑powered world, connecting people, data, and applications through our expansive fiber network and connected ecosystem. We enable secure, high‑performance connectivity across cloud, edge, and AI workloads for enterprises, governments,
This position is for an 8-12 week Internship to be conducted in Summer of 2027 (Jun-Sep 2027). *Minimum 12 weeks Internship is required for all International hires (who require JP VISA Support)* An Amazon MBA summer
An Amazon MBA role consists of leading a strategic project that is data intensive, analytical, centered on a real business issue, and representative of the full-time role. Our MBA graduates will have ownership of a high
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
Our Mission At Palo Alto Networks®, we’re united by a shared mission—to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking.
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a
At Snowflake, we are powering the era of the agentic enterprise. To usher in this new era, we seek AI-native thinkers across every function who are energized by the opportunity to reinvent how they work. You
Job Description(仕事内容) 1)CJC製品全般をベースとしたETO製品のプログラムマネジメント全般(企画~量産) 2)ETO受注予算(目標)策定及び、達成に向けたKPI設定、施策検討 3)関係部門と連携したETO製品の営業活動全般 4) ETO製品開発にかかわる経費・投資計画の立案、関係部門調整 5)当社が対応可能なETO製品に導く、顧客折衝 6)ETO製品に対し、顧客との共同研究・共同開発等、共創活動の窓口業務 7)ETO案件重点顧客に関する情報の社内関係先への伝達 8)市場及び、関係部門からのETO製品要望の取りまとめ 9)自部門エンジニアリング担当及び、技術部門の開発業務支援 <経験・スキル> ・客先折衝力(コミュニケーション力) ・前向き(ポジティブ)な方 ・業務用空調・冷凍冷蔵ならびに換気扇機器の製品知識がある方(出来れば) Carrier is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color,
Amazons mission is to be Earths most customer-centric company, and our award-winning Customer Service (CS) team is an essential part of that mission. Within CS, the APAC Service Delivery organization operates a complex, multi-country network, delivering