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（オンコロジー経験あれば尚可） 治験関連文書の作成経験（治験実施計画書の作成経験あれば尚可） 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
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new
Company Description Visa is a world leader in payments and technology, with over 259 billion payments transactions flowing safely between consumers, merchants, financial institutions, and government entities in more than 200 countries and territories each year.
Job Description ・FM-SOP、厚生労働省の医療用医薬品の販売情報提供ガイドラインなどの社内外の規制に沿った、SL/KDMとのScientific Exchange ・SL/KDMの依頼に応じた、最新科学情報、MISP等に関わる情報提供 ・Field Engagement Planに基づくIndividual Planの作成・実行 ・Scientific Exchangeを介したUnmet Medical Needs、Data Gap等のInsight収集 ・担当疾患領域に関わる論文、学会等の最新情報収集 ・SL Listの構築および更新 ・最新情報（Insight、論文情報、学会情報）の社内関連部署との共有 ・アドバイザリーボード、Medical Education等メディカルイベントのサポート Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Job Description Our Company is a biopharmaceutical company with a mission of discovering, developing, and delivering innovative medicines and vaccines which save and improve peoples’ lives. We have opened two roles in our Customer and strategy
About Recursive As the worlds population grows, we are facing a number of global challenges in the realms of environmental conservation, societal equity and ensuring that nobody is left behind in the transition to a digital
Mujin has transformed the field of industrial automation with its innovative robot control technology and is currently revolutionizing supply chains worldwide. Today, we are rapidly expanding our business both domestically and internationally, serving clients from Japan
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
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new
Mujin has transformed the field of industrial automation with its innovative robot control technology and is currently revolutionizing supply chains worldwide. Today, we are rapidly expanding our business both domestically and internationally, serving clients from Japan
Minimum qualifications: Bachelors degree or equivalent practical experience. 2 years of experience in account management, sales, or marketing. Experience developing and pitching solutions through various channels (i.e., over the telephone, email, in-person meetings) to prospects. Ability
Job Summary As project team manager, you will be responsible for managing Japan project management team while improving project management business process. In this position, you will have the opportunity to provide insight encourage the tam
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new
The successful candidate will play a critical role in our Information Security Management System project and compliance activities across the organization Responsibilities Contribute to the ISO27001 certification project and compliance activity across the organization. Plan, develop,
The successful candidate will play a critical role in our Information Security Management System project and compliance activities across the organization Responsibilities Contribute to the ISO27001 certification project and compliance activity across the organization by implementing
