JOBID:111690735304
Clinical Quality Specialist
アボットメディカルジャパン合同会社
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その他臨床開発
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医療機器メーカー/医療関連サービス
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東京都
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600万円~950万円
募集要項
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- 職種
- その他臨床開発
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- 業種
- 医療機器メーカー/医療関連サービス
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- 職務内容
- This role is designed to drive efficiency and productivity in clinical trial execution while maintaining the highest quality standard. The position ensures that clinical study data utilized for regulatory submissions comply with relevant regulations. Additionally, it drives quality management and continuous process improvement to ensure adherence to regulatory requirements throughout clinical study execution. This role may offer a pathway to managerial positions and/or broader responsibilities within the APAC region or globally, allowing candidates to expand their expertise across diverse regions.
We seek individuals who are eager to embrace challenges and drive innovation in clinical trial execution while upholding the highest quality standards. This role is ideal for those who aspire to develop their careers and take on various positions in the future, including People Manager and Project Manager roles.
【Major Responsibilities】
〇 GCP Compliance: Verify GCP compliance of foreign data submission for product approval.
〇 Regulatory Audits: Support GCP/GPSP conformity audits by competent regulatory authorities.
〇 Coaching and Knowledge Sharing: Demonstrate thorough knowledge of clinical research conduct, laws, regulations, and standards, and coach others in compliance with applicable company SOPs and policies.
【Clinical Quality】
〇 Primary responsibility is ensuring implementation of quality plan at every stage of the Clinical Trial process/operations.
〇 Implement quality assurance regulations.
〇 Write and revise standard operating procedures.
〇 Support and facilitate audits and regulatory inspections.
〇 Supervise all quality control aspects of the process (laboratories studies, clinical research, testing, operations).
〇 Ensure that standards are met and report potential issues either with quality or reliability of testing procedures.
〇 Lead implementation of new regulations.
〇 May support quality training.
【Process Management】
〇 Ensure high-quality clinical study deliverables on time.
〇 Ensure efficient document management and filing.
〇 Manage and oversee clinical vendors to leverage external resources and ensure quality deliverables from them.
〇 Manage multi-regional processes.
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- 勤務地
- 東京都
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- 給与
- 600万円~950万円
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- 給与(詳細)
- 経験・スキルをもとに優遇
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- 応募資格
- 【Minimum Requirements】
〇 Bachelor’s degree or equivalent
〇 >5 Years of experiene in clinical study roles, ensuring compliance with J-GCP, Ethical Guidelines for Medical Reserch 〇 Involving Human Subjectsm, and/or the Clinical Trial Act.
〇 Fluent in English and Japanese (speaking, writing and reading).
〇 Proven expertise in Microsoft Office Suite.
〇 Excellent written and verbal communication skills, including negotiation and relationship management.
〇 Strong problem-solving, organizational, analytical and critical thinking skills.
〇 Full knowledge and understanding of GCP.
〇 Strict attention to detail.
〇 Ability to interact with senior internal and external personnel on significant matters, often requiring coordination between organizations.
【Preferred Requirement】
〇 Degree in science/health-related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences).
〇 Experience in quality management and/or quality assurance.
〇 Clinical monitoring experience under Medical Device GCP, ISO14155.
〇 Project management experience under Medical Device GCP.
会社情報
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- 会社名
- アボットメディカルジャパン合同会社
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- 本社所在地
- 〒105-7115
東京都港区東新橋一丁目5番2号 汐留シティセンター
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- 資本金
- 25億200万円
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- 従業員数
- 連結約2,300名
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- 企業の特徴
- アメリカ・イリノイ州に本社を持つAbbott Laboratoriesは1888年に創業され、世界100カ国以上で事業を展開するグローバルヘルスケア企業です。
日本においては、治療機器、臨床検査、糖尿病ケア、栄養製品の4つの事業領域で製品とサービスを展開しています。
同社の強みは、世界規模の研究開発力と、それを日本の医療ニーズに合わせて展開する柔軟性にあります。
グローバルで確立された技術と品質を、日本国内の医療現場に適した形で提供できる体制が整っています。
また、患者中心のアプローチを重視し、医師・医療従事者との連携のもと、QOLの向上につながる製品開発に力を入れています。
予防から診断、治療、健康維持に至るまで、人生のあらゆる段階で人々の健康を支えるトータルソリューションを提供していることが最大の特徴です。
転職相談
医療機器業界における転職やキャリア設計、
求人などまずはカジュアルにご相談を
承っております。