Design Controls Jobs in Japan

職務内容 / Job DescriptionAssociate Director Clinical Quality Management (ADCQM) leads the planning and implementation of all quality activities adapting to changes in the environment through relevant Clinical Quality Management System. ADCQM is individual contributor and skill expert which meets o...

職務内容Description: The PS Epidemiologist (PSEPI) serves as a study lead for Post Authorization Regulatory Commitment Studies (PARCS) including post-marketing database study and use-result survey accelerating the generation of valuable real-world evidence. Leveraging extensive clinical research exp...

Role DescriptionThe Personal Assistant to the Head of R&D Japan is responsible for performing a wide range of high impact executive administrative and project-oriented activities in direct support of the Head of R&D Japan and the R&D Japan leadership team. The role involves initiating and managing e...

職務内容 職務内容 / Job Description呼吸器領域の医療施設医師薬剤師に対する医薬品の情報提供活動および適正使用の推進 応募資格(経験資格等) / Qualification (Experience & Skill etc.)Typical AccountabilitiesEducation Qualifications Skills and Experiencee必須 / Mandatory

Job Description業務内容1. グローバル戦略に沿った効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築2. 規制当局厚生労働省独立行政法人医薬品医療機器 総合機構などとの窓口業務3. 承認申請審査資料機構相談資料照会事項に対する回答等へのレビューアドバイスを通じ当局提出文書の質の向上に資する4. 承認申請審査...

職務概要臨床試験のデザイン分析解釈を関連する薬事規制要件標準業務手順書SOPおよびベストプラクティスに従って業務を行う臨床開発チームの中で特に臨床開発リーダー臨床薬理担当者統計担当者で効果的に協働し科学に基づいた統計の専門知識を生かし医薬品開発に貢献する職務内容試験デザイン統計解析計画統計解析結果の解...