Job Description 職務内容 クリニカルリサーチ領域での開発品の本邦臨床開発に係る以下の業務を担当する グローバル開発戦略における本邦臨床開発計画の立案・作成 本邦で実施する治験の科学的側面からのリード 臨床開発に係るPMDA相談準備・資料の作成 実施計画書の立案・作成（米国本社等、ステークホルダーへの説明・交渉を含む） ローカル試験：試験骨子から作成 グローバル試験：日本で実施するために計画書を適性化 他の治験関連資料（同意説明文書案、症例報告書、関連手順書等）の作成（他部門と協働） 治験実施のサポート（オペレーション部門と協働） 治験データのメディカルモニタリング 治験総括報告書の作成（メディカルライターと協働） 承認審査における臨床関連パートのリード 承認申請資料（CTD）臨床関連パートの作成（メディカルライターと協働） 臨床関連照会事項に対する回答作成 治験に関する学会発表及び／又は論文作成・サポート 必要とする資質 以下の業務を含む、製薬企業における臨床開発経験（５年以上） 臨床試験の運用経験（グローバル試験、ローカル試験、アジアン試験等） 臨床試験関連資料の作成・レビュー経験（治験実施計画書、同意説明文書等） 医学、薬学、公衆衛生学又は生命科学に関する学位（6年制学士又は修士以上） 未経験分野にチャレンジするフロンティア精神とリーダーシップ 国内外のチームメンバー及び社内外のステークホルダーと密接に協働するためのソフトスキル TOEICスコア730点以上に相当する英語力 Current Employees apply HERE Current Contingent Workers apply HERE Secondary
製品ごとの担当割ではなく，広く弊社製品の担当をしています。 チームワークと協力的な職場環境。 企業情報 * 外資医療機器会社 * 革新的な医療技術と幅広い製品ラインアップ 職務内容 * 各プロジェクトについては合意したタイムラインに沿って申請作業などを実施して頂きますが， * 申請書などのレビューはチームで行います。 * また，変更管理などの日常業務についてはチームで対応しています。 理想の人材 * CRO又は医療機器に関する業務経験 * グローバルチームで働く柔軟性と積極性があり，関係者との円滑なコミュニケーションが可能 条件・待遇 * 休日：日曜日、祝日、年末年始、会社指定休日 * 賞与：あり * 加入保険：雇用保険、労災保険、厚生年金、健康保険 Page Group Japan is acting as an Employment Agency in
Air Liquide Laboratories is one of the main R&D centers of the Air Liquide group. Its goal is to develop new and innovative solutions for the entire Air Liquide group. Air Liquide Laboratories is located at Innovation
Title: Medical Advisor / Medical Scientific Liaison FOP Company: IPSEN K.K. Job Description: As part of the Medical Affairs department, the MA/MSL is a hybrid, field-based scientific expert to external and internal stakeholders delivering non-promotional information
職位記述書 職務名 薬事規制スタッフ 勤務地 東京本社 レポート先 Quality, Safety & Regulatory Manager 担当ディビジョン Consumer Beauty & Luxury /Rimmel, Gucci, Burberry, CK, Tiffany,etc. 雇用形態 正社員 (full time) 業務内容 化粧品製造販売業者コティジャパンの薬事業務の遂行 主要業務 (70%) コティジャパン薬事規制業務 マーケティングおよび R&D と協力し、製品の成分、製品訴求、および製品表示が日本の規制に適合している事の確認 化粧品の申請書類作成・申請業務 化粧品の届出業務 (30%) 安全管理責任者（安責）業務
Job Description: Business Development Manager, Japan Huntsman’s Advanced Materials division is now looking for Business Development Manager, Japan. The primary function of this role is to identify new business opportunities and lead to launch these opportunities
Woven by Toyota is the mobility technology subsidiary of Toyota Motor Corporation. Our mission is to deliver safe, intelligent, human-centered mobility for all. Through our Arene mobility software platform, safety-first automated driving technology and Toyota Woven
About the Company Cybereason is on a mission to reverse the adversary advantage by empowering defenders with ingenuity and technology to end cyber-attacks. We have the technology, and now we are looking to expand our talent!
We are Reckitt そのチカラを自由に使え。 今の自分を超えていけ。 FREE YOUR POWER. PROGRESS YOURSELF. Home to the worlds best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the
We are looking for a solution consultant to join our Life Science & Healthcare solution consulting team in Tokyo. We are a team of product experts and is responsible for growing revenue from both existing and
Company Description Dynatrace exists to make the world’s software work perfectly. Our unified software intelligence platform combines broad and deep observability and continuous runtime application security with the most advanced AIOps to provide answers and intelligent
Automotive Connectivity Test Engineer Company Profile Capgemini Engineering combines, under one brand, a unique set of strengths from across the Capgemini Group: world-leading engineering and R&D and digital manufacturing expertise. With broad industry knowledge and cutting-edge technologies
■ 職務内容 / Job Description Drive development and execution of external communications strategy to drive a corporate reputation and advance science and therapeutic area leadership of AZKK. Leads a team of external communication managers and specialists
Cybereasons mission is to ‘protect it all’ – delivering unparalleled prevention, detection, investigation, and response for all endpoints: workstations, laptops, mobile devices and more. Our cyber-defence solutions combine machine learning and AI to analyze threats, connecting
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.
Medical Advisors provide medical and scientific expertise and guidance to investigators and CSU (Clinical Study Unit) staff performing clinical trials within a CSU cluster to ensure patient safety and scientific integrity of the protocol which ensures
About the Company Cybereason is on a mission to reverse the adversary advantage by empowering defenders with ingenuity and technology to end cyber-attacks. We have the technology, and now we are looking to expand our talent!
Were Celonis, the global leader in Process Mining technology and one of the worlds fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of
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.
Were Celonis, the global leader in Process Mining technology and one of the worlds fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of
