臨床開発(RA Specialist / Sr. Specialist) - 医療機器メーカー

勤務地 Tokyo, Japan
職種 正社員
給与 ¥7000000.00 - ¥10000000.00 per annum
専門
Sub-specialization 臨床試験 / CRA / CRC, 臨床開発(プロジェクトマネージャー), 薬事,
お問合せ Yasunori Kozaki
参照 JO-2011-450466
about Yasunori Kozaki

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[事業内容・会社の特徴]
外資系医療機器メーカー

[仕事内容]

  • PMDA・第三者認証機関向け薬事申請書作成・届け出業務、照会事項対応など
  • C1/C2の薬事償還業務
  • マーケティング部門、臨床開発、海外の開発部門との連携・折衝
  • 薬機法・関連法令にまつわる情報収集とSOP作成、更新業務 など

■Responsibility

  • Lead product registration projects (MD) and create registration documents in accordance with PMDAct.
  • Create and apply reimbursement document. Support preparing reimbursement documents for C1/C2 and obtaining reimbursement.
  • Review and approval product labeling and other related material to ensure consistency with labeling included in registration documents.
  • Review and approval product labeling and other related material to ensure consistency with labeling included in registration documents.
  • Help establish SOPs and work instructions.
  • Help conduct for training on SOPs, Work Instructions, PMDAct and other applicable laws and regulations
  • Internal consultation based on PMDAct including regulatory determination and support the team of the expertise area

■Engagement

  • Business Units: closely aligned with business unit(s), understand business priorities, keep business informed of RA strategy, progress, and resolve issues
  • BDX Regulatory: obtain product information required for product registration in Japan
  • LM: Request to obtain FMR and QMS inspection submission in align with product registration.
  • QM: provide required regulatory actions for product changes
  • PMDA: submit Shonin and Todoke to PMDA, manage inquiries from PMDA, lead consultation meeting with PMDA
  • Third party reviewer: submit Ninsho to the reviewers and manager their inquiries.
  • External Trade Association: be sensing, monitoring, and influencing as a part of industrial association.

[応募資格]

  • 出来ればクラスⅢ以上高度医療機器の新規申請経験
  • ビジネス英語力

[雇用形態]
正社員

[勤務地]
東京都

[給与]
700万〜1000万円
※能力・経験を考慮し当社規定により決定します。


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