医薬品業界における臨床開発業務等への就職、転職等に関する相談についてお話できます

  • 治験/臨床試験

経験内容

いつごろ、何年くらいご経験されましたか?

医薬品業界における臨床開発のプロジェクトマネジメント業務を約18年、mid-sizedグローバルCRO 2社にてJapan Country Manager、その他、非臨床研究、臨床開発オペーレーション (モニタリング業務管理)、安全性情報管理等の業務経験があります。

どちらでご経験されましたか?

外資系製薬会社、国内バイオテクノロジー会社、内資系及び外資系CRO

氏名・職歴の開示について

氏名:(開示前)

ClinTec International / Director of Operations Japan

プロフィール詳細を見る


自己紹介

- Management and Leadership: Over 15 years of project management experiences across early-stage, large-scale and Post-Marketing studies, and managed and mentored a dozen to two dozen staff including Clinical Leaders and CRAs, as well as cross-functional department managers
- Pharmacovigilance and Regulatory Oversight: Experiences in Post-Marketing Surveillance, and local pharmacovigilance support to global Medical Directors in clinical trials, with practical knowledge regarding local regulatory requirement, Japan Pharmaceutical and Medical Device Act (PMD Act) and GxPs, e.g. GCP, GVP, GPSP adopted throughout clinical development and product life-cycles
- Japanese Medical Documentation: Quality-assured regulatory and clinical documentations written in Japanese, including English translation, which fully reflects the understanding and interpretation for medical and scientific terminology in both languages
- Financial Management: Keep projects in line with budget and profit expectations, with proven records on the concrete achievement of expected profitability for all involved projects.

職歴

  • ClinTec International /Director of Operations Japan

    2015/10

  • ClinTec International /Director of Operations Japan

    2015/10

  • ClinTec International /Director of Operations Japan

    2015/10