RA Manager/薬事マネージャー - 医療機器メーカー

勤務地 Tokyo, Japan
職種 正社員
給与 ¥8000000.00 - ¥12000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 薬事,
お問合せ Taro Satake
参照 JO-2008-446108

Note: Fluent ~ Native level Japanese

[ポジション]
薬事マネージャー

整形外科領域の新規薬事申請経験がある方を募集。
即戦力としてご活躍頂けます。

[事業内容・会社の特徴]
外資系メディカル/大手外資系医療機器/外資系ヘルスケア

[仕事内容]
Key Responsibility

  • Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part
  • Take action to inquiry and/or instruction from Health Authority as a representative from Business Unit Regulatory Affairs.
  • Project Management for all project in the team. Make RA strategy for new product introduction and/or Clinical study having discussion and negotiation with Health Authority.
  • 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

[応募資格]
Qualifications
Education:

  • Bachelor's degree or an equivalent qualification is required, and an advanced degree is preferred.

Experience and Skills:

  • Experienced Class I/ II/ III NPI related action by covering several franchise and area/ Basic RA/QA/VS knowledge and experiences (At least 5 years)
  • Experience of Class III/IV NPI leveraging Clinical Study Report (CSR/CER)is highly regarded. (Not essential)
  • Demonstrates influence, negotiation and conflict resolution in matrix environment.
  • Rich experience in communication of regulatory requirements and regulatory issues.
  • Fluent communication both in Japanese and English (ex, TOEIC >800)
  • Strong scientific background (e.g. Mechanical Engineering, Biology, Chemical)

[雇用形態]
正社員

[勤務地]
東京

[勤務時間]
フレックスタイム、在宅勤務有り

[給与]
800〜1200万円程度 (ご経験、スキルによりご相談)

[待遇・福利厚生]
社会保険完備(健康・厚生・雇用・労災)、従業員持株会、財形貯蓄制度、育児支援制度、住宅融資制度、産前産後休暇・育児休職、育児短時間勤務制度

[休日休暇]
完全週休2日制、年末年始休暇、年次有給休暇、リフレッシュ休暇、ボランティア休暇

[選考プロセス]
書類選考、面接数回を予定

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