Plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. Applies comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas. 専門分野の高度な知識を必要とするエンジニアリングプロジェクトまたは研究を計画,実施,指揮する。幅広い職務領域において,エンジニアリングの原則と実践に関する包括的かつ多様な知識を適用し,業務を行う。 Ø Oversees the
( 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
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Lead in GQP QA operational activities for the business for company products. Ensure effective compliance, continuous improvement activities, and overall quality processes. Client Details * Global Pharmaceutical company specializing in generics, biosimiilars, APIs, and new products
* This position will be responsible for managing assigned clinical studies globally and locally, overseeing study activities, budgets, timelines, and vendor relationships. * The role involves leading a multifunctional team, ensuring adherence to regulatory requirements, managing
職種 正社員 職務明細 Job Scope - Consultant for improving dealer service business & process, service structure & service profit based on Stellantis Japan (SJ) service strategy - Enhancement of AM’s activities. (Strategy, Target setting, Progress, Result,
職種 正社員 職務明細 LVMH Fashion Group Japan Internal Control provides services to several fashion brands, representing about 180 stores as well as 200 employees in charge of back-office operations. The mission of the Internal Control Specialist
職種 フルタイム(契約) スキル・資格 • 最低10年の経験、LSドメインの知識を持つサポートプロジェクト経験 • ITILの知識は必須。 • 日本語： 日本語ネイティブ、ビジネスレベルの英語または会話レベル以上 • Minimum 10 years of experience, Support project experience with LS domain knowledge • ITIL knowledge is a must, should have worked in support engagements •
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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.
Görev Tanımı The Position The Pharmacovigilance Senior Specialist (PV Senior Specialist) will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance organization and reporting into the head of Japan Pharmacovigilance. The PV Senior Specialist is
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Job Description Main Responsibilities: Support the Quality Assurance activities of the Marketing Authorization Holder as described below: Ensure the implementation of GQP Quality Assurance activities and ensure activities operate within established policies/procedures, global requirements, and all
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
職務内容 Key Accountabilities Country Quality System management Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance,
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的： ・GMP/GDPに基づき、安全/品質を担保しながら、輸送/保管の倉庫オペレーションを安定的に実行できるように管理する ・Job Purpose: Manage the transportation/storage warehouse operations stably while ensuring safety/quality based on GMP/GDP. 主な業務内容： ・輸送/保管におけるQMS及びGDPガイドライン等の要求事項を遵守できるように管理する ・関連するSOP/WIの維持管理を行う ・担当業務の逸脱報告/変更管理を実施する ・3PLと合意されたKPI管理を行い、倉庫オペレーションを適切に運営する ・回収及び返品オペレーション管理 ・社内外査察対応 ※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。 Key Responsibilities: ・Manage to comply with
Location: Shinagawa-Ku, Tokyo, Japan Job ID: R0021594 Date Posted: 2023-08-17 Company Name: HITACHI ENERGY JAPAN, LTD. Profession (Job Category): Engineering & Science Job Schedule: Full time Remote: No Job Description: Mission Statement: You will lead planning,
