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Medical Affairsの求人-yamato - 5 Job Positions Available

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This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 (

Johnson And Johnson  25 days ago
Mastercard jobs

Job purpose Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. In order to build a trust with External Experts (EE) and scientific community through, MSL needs to

Mastercard  1 day ago
Mastercard jobs

Job purpose: Responsible for implementing the Medical Affairs Plan of specified Team strategies, driving a consistent approach to carrying out scientific engagement activities internally and in the field; ensuring compliance with all relevant regulations and GSK policy/code of

Mastercard  1 day ago
Mastercard jobs

Job purpose: Plan and execute the marketing strategy and tactics to ensure commercial success of the product Key responsibilities: To strategically drive “Shape the market” & “Shape the product”, work with Brand Lead to develop and

Mastercard  1 day ago
GSK jobs

Job Purpose: MSL Manager is accountable for leading and driving performance of MSL department in corresponding therapeutic area. MSL Manager drives MSL department by setting the right business objectives and priorities aligned with global counterpart to

GSK  1 day ago

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