Return Flight Program-Business Operations Specialist - Tokyo, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000422752 Date Posted: 2024-04-17 Location: JPN - Tokyo, Japan Job Description Qualifications: (Japanese Follows) The “Boeing Return Flight program” is a
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Take lead in diverse range of RA projects to support clients in obtaining regulatory approval. Provide expertise in RA strategy/development. Client Details * One of the largest global CROs in the industry * Partnering with small to
This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 ( 目安:
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
Job Description Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. Manage and maintain regulatory operational activities in drug development, NDA
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
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 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
Are you experienced in CMC regulatory affairs or in generating high-quality documentation related to drug manufacturing and marketing approval/maintenance? Do you have a strong understanding of CMC requirements in Japan? We are seeking a CMC Expert to join
Minimum qualifications: Bachelors degree or equivalent practical experience. 9 years of experience working on technology policy issues within government, think tanks, public interest groups, or related industry associations. Ability to communicate in English and Japanese fluently
Head of Compliance (HoC) leads the Local Compliance department and engages support from Regional Compliance to ensure the organisation is compliant by desire and design by embedding sound Compliance Risk Management practices throughout the organisation. You
Business Operations Specialist - Tokyo, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000422120 Date Posted: 2024-04-30 Location: JPN - Tokyo, Japan Job Description Qualifications: (Japanese Follows) Boeing Global Enterprise Services (BGES) has an exciting opportunity
( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
職務 概要 Position Summary : 富士 New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering )は以下職務を行う。 The New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering ) for as follow l 富士工場新製品導入のガバナンス,プロジェクトの実施 Execute governance and project for Fuji
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
Job Description Job Responsibilities: Develop and execute strategies that align with the global business units’ strategy. Focus business areas products include ImmunoDiagnostics and Molecular Diagnostics. and other areas may be added as appropriate. Identify and evaluate
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance
Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected,
Description Kenvue is currently recruiting for: Legal Counsel This position reports into Legal Director Consumer Health Korea and is based at Ebisu, Tokyo, Japan. Who We Are At Kenvue , we realize the extraordinary power of
