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部署・役職名 | [MedTech] 薬事本部 薬事マネージャー(循環器グループ) |
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職種 | |
業種 | |
勤務地 | |
仕事内容 |
Key Responsibilities: - Project Management for all project in the team. Make RA strategy for new product introduction to drive our business. - Take action to inquiry and/or instruction from Health Authority as a representative from Business Unit Regulatory Affairs in J&JKK. - Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part - Assist the group member as a first-line manager, to plan and evaluate performance. - Mentor, coach, train and develop the direct reports. Evaluate performance and provide opportunities for growth. - Communicate with all stakeholders including commercial and OpCo related RA matters in the team. - Contribute to RA organizational action as DRI or SME for assigned project - Contributes to development of team budget and implements cost controls. |
応募資格 |
【必須(MUST)】 Education:- Bachelor’s degree or an equivalent (or higher) is required Experience and Skills: Required: - Experienced Class III/IV NPI related action (At least 5 years) - RA knowledge and experiences - People management experience (2 or more members) - Work experience with global team - Business level communication both in Japanese and English - Demonstrates influence, negotiation and conflict resolution in matrix environment. - Rich experience in communication of regulatory requirements and regulatory issues. 【歓迎(WANT)】 Nice to have:- Experience of Class III/IV NPI leveraging Clinical Study Report (CSR/CER) is highly regarded. (Not essential) - Scientific background (e.g. Mechanical Engineering, Electrical Engineering, Biology, Chemical) |
アピールポイント | 女性管理職実績あり 従業員数1000人以上 創立30年以上 産休・育休取得実績あり 教育・研修制度充実 管理職・マネージャー |
リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
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 | 2024/08/20 |
求人番号 | 3790954 |
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