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部署・役職名 | [MedTech] 臨床開発 Clinical Affairs Staff |
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職種 | |
業種 | |
勤務地 | |
仕事内容 |
Overview: This position is accountable for leading in the development of clinical evidence generation and dissemination strategies across assigned projects. Main responsibilities and duties: ・ Lead to evidence generation strategy with collaboration relationships with all cross-functional partners (e.g. Marketing, Medical Affairs, Regulatory Affairs, HEMA, etc) as a clinical member. ・ Responsible for delivery of assigned clinical programs leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP) ・ Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/ECs, regulatory agencies, societies, associations, etc; ・ Lead in clinical scientific discussions with PMDA to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including sponsor regulatory inspections. |
応募資格 |
【必須(MUST)】 ・3 years of CRA (臨床開発) experience (医療機器または医薬品)・Business level English and Japanese (oral and written communication) ・Project planning and managing skills ・Demonstrates influence, negotiation, and conflict resolution skills. 【歓迎(WANT)】 ・Team leadership experience |
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 |
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 | 2024/12/06 |
求人番号 | 3966869 |
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転職・求人情報の詳細をご覧になる場合は会員登録(無料)が必要です