企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
Medical Office Coordinator – General Medicines Tokyo, Japan - About the job As Medical Office Coordinator within our General Medicines Medical team, youll start your career journey with hands-on administrative support and grow into a meaningful
Job Purpose At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Responsibility: 変更提案に対する薬事影響評価（変更カテゴリ―、必要なデータ）の特定 市販製品（低分子医薬品及び/又はバイオ医薬品）の変更管理における薬事的なリスク低減策を含むCMC薬事戦略の立案・実行支援 薬事アクション（一変・軽変・相談・照会回答）に供する高品質な資料の適時作成 海外関連部署に対する本邦規制要件の提示・解説 （担当マネージャー）チーム成果物（提案・資料等）の品質保証（整合性、適切性） Role: 製造所の変更提案に対し適時薬事影響評価を行う。 市販製品の薬事アクション（一変・軽変・相談・照会回答）に対し、提言、方針策定の支援、海外を含む関連部署との交渉を行う。 薬事アクション（一変・軽変・相談・照会回答）に供する資料につき、海外薬事を含む国内外の品質部門と協働して資料作成を行う。 他部署との協業上の問題（役割分担等）の解決・調整を支援し、プロセス改善に寄与する、あるいはその提言を行う。 （担当マネージャー） チームメンバーの上記活動に対する能力開発を含めた指導・支援を行う。 関連部署との個別の課題／問題につき、必要な調整・解決のための協議を行う。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Basic Qualification スキル Skill 分析化学、製剤・薬剤学・プロセス工学（特に製造方法あるいはGMP）等に関する知識 品質に関わる国内規制、各種ガイドライン及び日本薬局方などの知識 ロジカルシンキング（論理的に物事を整理し、本質を見極められる） 他者との緊密な協力関係を構築し、協業できること Word、Excel、PowerPoint、Outlook、 経験 Experience CMC関連業務（分析、製造、QA、CMC薬事など、関連業務5年以上が望ましい） CMC薬事経験必須、スタッフは関連業務経験の有無により以下を考慮することがある - 変更管理業務を含むCMC薬事への興味の高さ・習得意志の強さ - 業務に利用可能な傑出したスキル（例：英語がnative levelなど）またはコンピテンシー（自己認知・成熟性、変革行動、顧客志向性など）を1つ以上有する 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
General Information Job Advert Title: PV Reporting and Information Management Professional Location: Nihonbashi, Tokyo Division: Regulatory Affairs and Pharmacovigilance Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative
Position SummaryYou will lead health technology assessment (HTA) and evidence synthesis activities to support access and reimbursement in Japan. You will work with cross-functional colleagues in market access, clinical development, regulatory, and global HEOR teams. We
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team. Reporting to the Head of Global Regulatory Affairs CMC
The Senior Medical Writer is responsible for planning, preparing, and managing medical writing projects as well as creating and reviewing documents in some instances. Reporting to the Head of Clinical Development Japan, the Senior Medical Writer
Job Overview As Biogen embarks on its first launch in a new therapeutic area, the Medical Manager, Pipeline will serve as a strategic architect and scientific leader, responsible for building the medical function from the ground
Job Description Specialty Care Commercial Strategy and Operation (Associate Director/Senior Specialist) Our company is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that improve and save lives. We are seeking
職務の目的および主な業務内容 主に下記の業務を担当いただきます 。 事務サポート業務内容 -チーム内および社外との会議調整 -資材審査のサポート（承認申請対応のみ。コンテンツの作成・修正は対象外） -社内外ステークホルダーへの対応（メール対応） ※職務内容および勤務地の変更範囲は会社の定めるところとする。 必要な条件 スキル Microsoft Outlook／PowerPoint／Word／Excelを用いた基本的な業務経験 社内外ステークホルダー対応（事務連絡・調整）の経験力 業務を主体的にリードいただける方 学位/資格/語学力 学位不問 望ましい条件 スキル Content Lab（社内システム）を用いた資材審査プロセスの対応経験※未経験の場合でも、配属後に業務を通じて習得可能経験 経験 製薬会社での業務経験 学位/資格/語学力 学士号（ビジネス/医学関連/関連分野） 日本語ビジネスレベル以上 Why GSK? Uniting science, technology and talent to get ahead of
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
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.