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
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
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
