Associate Medical Director/臨床開発医師 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 09月 22日

求人情報

臨床開発医師

求人管理No.011065

会社概要

Associate Medical Director

Minimize potential risk to clients by managing medical aspects of contracted tasks.

募集要項

Project Related Medical/Safety Support:
・ Minimize potential risk to and clients by managing medical aspects of contracted tasks. This includes, but is not limited to, medical monitoring of all safety variables (AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication for protocol restrictions and unblinding requests). Scope of work also includes discussion internally with medical monitors in Japan, APAC and global and project team colleagues internally, as well as with principal investigators and clients of all medical issues during the course of a study by proper medical judgment, interpretation and decision.

・Medical review of serious adverse events
・Ensure tasks delegated to medical monitors are properly executed. Adhere to applicable regulations and ICH guidances regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to corporate policies and SOPs/WPDs.
・Present standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand business.
・Provide medical consultation to team members and help manage protocol related medical questions. Communicate clearly with project team members and clients, maintaining open communication to ensure all procedures are followed appropriately.
Provide therapeutic training and protocol training on assigned studies, as requested.
・Perform listing reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety listings as well as use of Patient Profiles and other tools to assess for potential safety signal.
・This position will be assigned to APAC components of gl

募集条件

  • ・Academic Qualification: -MD degree
    ・Required Knowledge and skill:
    ・ A certified license of a medical doctor. - Experience in hospital settings for at least 5 years, with a specialty of oncology (preferred) or internal medicine related therapeutic area. -Be able to work both in an Japan organization and a regional/global environment. -Experience in regulatory authority or pharma would be a plus, but not a must.
    ・Language: Both Japanese and English proficiency.

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • なし

勤務時間

  • 09:00-18:00 フレックス制度あり コアタイム:11:00~16:00

給与

  • 年俸制:1000~1300万程度