募集要項
- 募集背景
- 新規雇用
- 仕事内容
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SUMMARY
Responsible for formatting and publishing electronic documents and building regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs ＆ JNDAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications （eg, FDA, EMA, PMDA, ICH, etc）
JOB RESPONSIBILITIES:
• Manages staff and/or vendors who electronically format, publish electronic documents and builds Regulatory submission deliverables. Ensures quality, accuracy, and submission readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications （eg, FDA, EMA, PMDA ICH, etc）
etc.
- 応募資格
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- 必須
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Education
• Bachelor’s Degree
xperience
• 8＋ years of pharmaceutical experience
• Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications （eg, FDA, EMA, PMDA, ICH, etc）.
• Advanced knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.
- 募集年齢(年齢制限理由)
- 長期勤続によりキャリア形成を図る為 （長期勤続によりキャリア形成を図るため）
- 雇用形態
- 正社員
- 勤務地
- 埼玉県 / 千葉県 / 東京都 / 神奈川県
- 年収・給与
- 1100万円 ～ 1300万円ベース給与 + ボーナス + LTIs
