職務 概要 Position Summary : 1. The launch of new technology, products and technical transfers. 2. The validation process and execution (Process and Cleaning Validation). This includes lifecycle management of products (including continuous improvement). 3. Packaging
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。会社の最重点領域の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。OCS部のVisionとして「様々な知恵と経験を結びつけてOCS 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（JCD）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】 がん領域の臨床開発プロジェクトにおける以下業務を担当 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 ローカル試験（試験骨子から作成） グローバル試験（主に翻訳）：米国本社や海外ベンダーへの説明、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） Current Employees apply HERE Current Contingent Workers
【障がい者雇用】Interior Composite Materials & Process Engineer - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426793 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology (BR&T) defines, executes
Return Flight - Interior Composite Materials & Process Engineer - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426776 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology
Interior Composite Materials & Process Engineer - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426362 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology (BR&T) defines, executes
Location: (HE)Office_Kokubu Job ID: R0053878 Date Posted: 2024-06-24 Company Name: HITACHI ENERGY JAPAN, LTD. Profession (Job Category): Engineering & Science Job Schedule: Full time Remote: No Job Description: Your responsibilities: You will be responsible for engineering in
Blackstone is the world’s largest alternative asset manager. We seek to create positive economic impact and long-term value for our investors, the companies we invest in, and the communities in which we work. We do this
Work Schedule Other Environmental Conditions Office Job Description At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to
Work Schedule Other Environmental Conditions Office Job Description Product Applications Specialist - 3D Visualization and Analysis Software When you are part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance,
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
Cohesity is a leader in AI-powered data security and management. Aided by an extensive ecosystem of partners, Cohesity makes it easy to secure, protect, manage, and get value from data — across the data center, edge,
Role Details Business, Location: WITec, Tokyo, Japan Role: Field Service Engineer Reports to: Oi Service Technical Manager Direct Reports: None Primary Purpose: Oxford Instruments WITec is seeking an experienced Field Service Engineer with a strong both
The Construction Project Manager is responsible for managing and overseeing construction engineering, planning, and design of all strategic asset investments of Maersk L&S facilities in APA. Working closely with cross-functional teams and external consultants to deliver
Job Description Summary of job scope: We are seeking a Machine Learning Engineering Paid Internship, with a growth mindset, to work closely with cross-functional business teams adopting agile ways of working, to create business values and
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s
Description Kenvue is currently recruiting a PR Specialist. This position reports into Senior Manager, External Communications, and is based in Tokyo, Japan. Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built
