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  7.  >  Preclinical Science ＆Translational Safety Japan

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[Innovative Medicine] R＆D, Group Manager（Sr. Principal Scientist）, Pharmacokinetics ＆ Drug Metabolism, Preclinical Science ＆Translational Safety Japan

年収： 1200万 ～ 1600万 ?

採用企業案件

採用企業

ヤンセンファーマ株式会社

  • 東京都

    • 会社規模501-5000人
  • 医薬品メーカー
部署・役職名 [Innovative Medicine] R＆D, Group Manager（Sr. Principal Scientist）, Pharmacokinetics ＆ Drug Metabolism, Preclinical Science ＆Translational Safety Japan
職種
業種
勤務地
仕事内容 ■JOB SUMMARY:
1. Conduct 1) to 4) below in the non-clinical area.
1) Ensure appropriate studies are conducted at appropriate times to support development in Japan.
2) Ensure study results and their interpretation meet Japanese requirements.
3) Ensure resolution to all project-related problems that might affect development in Japan.
4) Ensure non-clinical submissions are of the highest scientific quality, and these are prepared within timelines.

2. Focus on self-evaluation, self-management and self-development.
3. Educate and coach the group members and make proper assignments and fair performance appraisals.
4. Plan and execute strategy of the group
5. Shape regulatory acceptance aligned with international standards through external/industry activities.

■KEY RESPONSIBILITIES: List major responsibilities and duties of the position.
1. Conduct 1) to 9) below in the non-clinical area.
1) Research global (e.g. JJPRD) documents and published papers and see whether or not the study items and/or results meet requirements by the Japanese
regulatory authorities and see whether or not there is a critical issue against clinical studies and/or NDA's.
2) Make and discuss possible resolutions to a problem for clinical studies and/or NDAs with relevant colleagues and put the most appropriate resolution (e.g. additional studies and/or documentation) into practice.
3) Prepare high-quality non-clinical documents for clinical studies and/or NDAs.
4) Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with global, JPKK and/or external experts.
5) Provide support for preparing high-quality documents for marketing.
6) Discuss the requests for non-clinical studies from external investigators with relevant colleagues and perform joint studies if needed.
7) Provide relevant colleagues with suggestions from non-clinical perspectives.
8) Establish, maintain and improve relationship to relevant colleagues and external experts.
9) Support the group members, and check the documents and/or responses prepared by the group members in terms of science and quality

2. Make the group's objectives in line with R&D's goal and share them with the group members.
3. Assign the group members to projects and change the members if needed.
4. Give feedback and coaching to the group members and make fair performance appraisals.
労働条件 ■勤務地：
Chiyoda / Japan
応募資格

【必須（MUST）】

■Experience/Knowledge
. Expert knowledge of the non-clinical area, advanced knowledge of non-clinical notifications/guidance/guidelines in Japan/EU/US, advanced knowledge of processes for IND/NDA, advanced knowledge of other non-clinical areas, and intermediate knowledge of clinical areas.
. Experience in non-clinical areas for more than 12 years or equivalent to the experience.
. Experience with activities outside the company or department

■Skills/Capabilities
. Advanced presentation and negotiation skills with global mindset.
. Advanced communication skills in English.
. Advanced skills in managing and developing the group members, including coaching, feedback and mentoring.

■Qualification/Certificate
Ph. D or Equivalent
受動喫煙対策

その他

「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日 2026/07/27
求人番号 9278823

採用企業情報

ヤンセンファーマ株式会社
  • ヤンセンファーマ株式会社

  • 東京都

    • 会社規模501-5000人
  • 医薬品メーカー

  • 会社概要

    私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
    ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
    満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
    さんの手元に届けることができるよう取り組んでいます。

    私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
    （Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
    ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
    神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
    かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
    ライフ）の向上を目指した支援活動などをおこなっています。

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