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              外資製薬メーカー

              Japan Regulatory Lead (JRL), Regulatory 

              • 大企業
              • 年間休日120日以上
              • フレックス勤務
              • 産休・育休取得実績あり
              • 社宅・住宅手当有
              • 退職金制度有
              • 英語を活かす

              製品/プロジェクトの日本の規制戦略の計画と実行を担当

              仕事内容
              Japan Regulatory Lead (JRL) is responsible for planning and execution of Japan regulatory strategy of the assigned products/projects by
              ・Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan project team and Global Regulatory Strategy Team(GRST)
              ・Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input are properly understood by the governance bodies in GMeds, iMeds and MedI for their quality decisions through communication with GRST/Global regulatory execution team (GRET).
              ・Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.
              ・Managing quality regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.
              ・JRL will also contributeto regulatory policy shaping within the TA by working closely with TA RAD and Regulatory Policy and Intelligence Department
              ・JRL will work flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables
              応募条件
              【必須事項】
              ・Bachelor’s Degree in Science or related discipline
              ・Relevant regulatory experience or experience elsewhere in Pharmaceutical industry
              ・Cross-functionalproject team experience
              ・Thorough knowledge of the drug development process
              ・Written and verbal communication skills
              ・Scientific knowledge sufficient to understand all aspects of regulatory issues
              ・英語 English:Business English (Speaking level 6 or above)
              【歓迎経験】
              ・Getting drug/deviceapprovalsand supporting launch activities, such as a price negotiation, as a leading person
              ・Drug development and regulatory affairs experience in outside of Japan
              ・Working with external bodies, such as co-development companies and key opinion leaders, as a leading person.
              ・Line management
              【免許・資格】

              【勤務開始日】
              応相談
              勤務地
              【住所】東京、大阪
              年収・給与
              650万円~1200万円 
              検討する

              外資製薬メーカー

              【FIN 政策情報部】Pricing Manager, Individual Contributor or Staff, Pricing Group

              • 大企業
              • 年間休日120日以上
              • 産休・育休取得実績あり
              • 女性が活躍
              • 社宅・住宅手当有
              • 退職金制度有
              • 英語を活かす

              マーケットアクセスチームが効果的な情報を使用して価格戦略を策定できるよう支援

              仕事内容
              ・Make prices of assigned products optimal and contribute to company’s profit.
              ・Lead strategic price negotiation with MHLW on assigned products and manage preparation for the negotiation.
              ・Assess price potential of assigned products and help Market Access team develop pricing strategy with effective input.
              ・Contribute business planning with insightful analysis on healthcare & pricing environment change through close monitoring of discussion at Government councils and pricing tendency.
              ・Collaborate with other department colleagues to gain support for optimal pricing based on pricing strategy.
              ・Collaborate with Global Pricing & Reimbursement team in order to align pricing strategy with global strategy and gain support from global team as needed basis.
              ・Build strong relationship with MHLW officials and industry colleagues through trade association activities, and leverage them for optimal pricing outcome.

              ・Medical or Pharmaceutical Back ground
              ・Familiarity with operating in Global business
              応募条件
              【必須事項】
              ・Bachelors degree in relevant field (Marketing, Science, Economics or pharmacists)
              ・Sound knowledge of healthcare business and reimbursement pricing regulations in Japan.
              ・Interpersonal and communication / persuasion skills
              ・Clinical Development Knowledge
              ・Business level proficiency in Japanese and English
              【歓迎経験】

              【免許・資格】

              【勤務開始日】
              応相談
              勤務地
              【住所】東京
              年収・給与
              650万円~1000万円 
              検討する
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