本社(大阪府大阪市中央区)又は東京支店(東京都千代田区)
Head Office (Chuo-ku, Osaka) or Tokyo Branch (Chiyoda-ku, Tokyo)
※将来的に会社の定める場所(国内事業所および海外など)へ変更になる場合があります
This may change in the future to a location determined by the company (domestic offices or overseas, etc.)
SHIONOGI製品のMedical Plan及びTactics,予算を立案し,上級管理職から承認取得に責任を負う.この過程においては国内及び海外グループ会社,並びにアライアンス企業の関連部署との協力体制を取る.また,定期的にMedical Plan/Tacticsの進捗を管理し,課題解決をリードする.
メディカルアフェアーズ部にて立案される研究計画をレビューし,Brand PlanやMedical Planとの整合性や,研究シノプシスの妥当性を確認する.研究開始後は担当者による研究実行をサポートする.
担当領域/製品のPublicationについて,科学的インプットを行う.
メディカルアフェアーズ部における領域/製品の代表として,社内の研究開発,マーケティング等の部門との協同を行う.
Lead the development of the Medical Plan and Tactics, as well as the associated budget, and obtaining approval from senior leadership. This requires a close collaboration with relevant departments in both domestic and overseas subsidiaries as well as alliance companies.
Track the progress of the Medical Plan/Tactics and lead problem-solving activities.
Review research plans developed by the Medical Affairs department, ensuring alignment with Brand Plans and Medical Plans, and confirming the validity of research synopses. Provide support for the execution of research by the assigned personnel.
Provide scientific inputs for the Publication of the assigned area/product.
Represent the assigned area/product within the Medical Affairs department and collaborate with other departments such as Research & Development and Marketing within the company.
This may change in the future as determined by the company.
【必須要件】
・医療関連(例:医学、薬学、生命科学など)の学士号以上の学位
・GCP/倫理指針/臨床研究法の理解
・治験・臨床研究の研究計画の立案経験
・開発製品又は市販後製品の責任者/リーダー経験
・CNS領域(不眠症,ADHD,うつ病)の治験又は臨床研究への従事経験
【望ましい要件】
・TOEIC800点以上
・開発製品又は市販後製品の論文著者経験
【Essential criteria】
- Bachelor's degree or higher in a medical-related field (e.g., medicine, pharmacy, life sciences)
- Understanding of GCP/ethical guidelines/clinical research regulations
- Experience in developing protocol for clinical trials/clinical research projects
- Experience as leader for investigational or post-marketing products
- Experience in clinical trials or clinical research in the CNS field (insomnia, ADHD, depression)
【Desirable criteria】
- TOEIC score of 800 or above
- Experience as an author of scientific papers for investigational or post-marketing products