FMT(Fecal Microbiota Transplantation)実施基盤や生命科学研究、バイオインフォマティクス研究を活用し、消化器系疾患や免疫系疾患を対象とした複数パイプラインの開発と探索的研究を進めています。また、順天堂大学消化器内科が進めている腸内細菌叢移植療法を用いた臨床研究(潰瘍性大腸炎治療)を社会実装すべく安全で高品質なFMT療法の普及拡大に注力しています。
業務内容
医薬品等の薬事規制対応/薬事申請業務
PMDA 対応業務(各種面談/ミーティングの設定や照会事項等受領、回答提出)
FDA対応業務(各種面談/ミーティングの設定や照会事項等受領、回答提出)
医薬品等の国内承認申請業務
国内外開発薬事(薬事に関する社内連携推進)
国内外の薬事規制に関する情報収集
本ポジションの魅力・やりがい
弊社はFMTという新しいモダリティの医薬品を開発する国内のトップランナーです。前例もなく誰も答えを知らない中で、新しい技術の医薬品を自分たちの手で開発できるという魅力があります。
ベンチャー企業の経営に直結した業務であり、経営の臨場感を得ながら全員でIPOを目指すことにより起業家精神を養いながらキャリアップすることができます。
医療機関やアカデミア、創薬研究部門・CMC部門とも密接に連携して開発を進めますので、幅広い分野の知識を習得することができます。
海外の専門家とのコミュニケーションがありますので、グローバルに活躍するチャンスがあります。
応募要件
必須要件
薬事業務経験
MS OfficeまたはGoogle Workplaceを使ったレポート・資料作成やデータ整理ができる方
Slack等のチャットツールを使ったコミュニケーションに抵抗がない方
英語資料を問題なく読めること、英語によるコミュニケーション能力(ビジネス会話レベル)
大学の先生等とコミュニケーションを円滑に行える方
原則として30代以降(ただし経験や能力を鑑み20代も考慮する)
歓迎要件
FDAにおける薬事の経験
薬事戦略立案の経験
臨床開発関連薬事の経験
チームで協力しあい課題解決することに楽しみを持てる方
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