* Manage timely product approvals for target indications in Japan * Align with global strategies and Japanese healthcare requirements * Collaborate across departments for regulatory compliance * Develop and update Japanese clinical development plans * Handle submissions
開発部門では国内外で実施する臨床試験の企画・管理・モニタリングなど様々な業務を行っており,チームで企画からモニタリング業務まで担当します。 企業情報 * 外資系製薬会社 * イノベーション:研究開発への投資を通じて、新しい医薬品や治療法の開発に取り組んでおり、疾患の治療と予防に貢献しています。 * 将来の医療ニーズに対応するために多岐にわたる製品パイプラインを保有しています。 職務内容 * 治験実施計画書、同意説明文書及び症例報告書の作成(補助) * モニタリング計画書等、各種手順書の作成 * モニタリングおよび施設対応の実施責任者として、モニターを指揮して治験を実施 * モニタリング報告書・必須文書・症例報告書等の確認 * 担当試験に係わるチーム内(モニター)教育 理想の人材 * 臨床開発のモニタリング経験 * リーダーシップ、コミュニケーション、プレゼンテーションのスキル 条件・待遇 * 休日:日曜日、祝日、年末年始、会社指定休日 * 賞与:あり * 加入保険:雇用保険、労災保険、厚生年金、健康保険 Page Group Japan is acting
* Takes accountability and serves as the first line of contact at the study level. 企業情報 * Top 3 Pharmaceutical Company * Rich pipeline with nice promotion space 職務内容 * Takes accountability and serves as the
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
Job Description The position takes a responsibility for medical contents in all clinical development programs in assigned therapeutic areas (such as dementia, movement disorders, neuromuscular, and MS/Immunology etc.) in Japan. The individual functions as a scientific and
企業概要 At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is
* Responsible for supporting the Project Management group to ensure smooth and effective study delivery through organising of important documents and files. Client Details * European headquartered, pharmaceutical company with a mission to help patients with
* Contribute to the development of innovative cancer therapies by working collaboratively with R&D, program management, clinical operations, biostatistics, and data management teams * Contribute to the clinical strategy and development plans for various oncology indications * Provide
Responsible for generating post-marketing safety evidence of products using real-world data in Japan. 企業情報 * Top Global Pharmaceutical Company * Highly specialized in Oncology area with rich pipeline 職務内容 - Creates study report, and Re-examination dossier
To provide the leadership to the project teams to build high performing teams for maximizing the value of products in Japan. Ready to level up to be a leader of Global Clinical Project Management? 企業情報 * Top
Oversee safety and pharmacovigilance in clinical trials, including adverse event analysis, reconciliation, safety reporting, regulatory compliance, stakeholder liaison, and document management. Client Details Leading pharmaceutical innovator driving the forefront of medical discovery through cutting-edge research and development