募集要項
- 募集背景
-
Job Summary: Clinical Development Manager
Manage Post-Marketing Surveillance (PMS) operations, including team leadership, recruitment, training, and communication with stakeholders like physicians, corporate representatives, and regulatory teams.
- 仕事内容
-
Key Responsibilities:
● Develop and implement strategies with internal stakeholders (e.g., KOLs, corporate/division management, marketing, finance, regulatory, quality assurance, logistics) to manage domestic PMS.
● Ensure compliance with GPSP, guidelines, and standards.
● Adhere to timelines and achieve planned milestones.
● Select and contract with CROs, oversee compliance with protocols and provide guidance for corrective action.
● Prepare various reports (e.g., annual reports to PMDA, performance evaluations, interim reports).
● Address PMDA inquiries related to PMS.
● Manage and guide group members.
- 応募資格
-
- 必須
-
Skills & Qualifications:
● 5+ years of experience in medical device, pharmaceuticals, or biopharmaceuticals - with preference to medical devices related to cardiovascular.
● 5+ years of experience in PMS planning & implementation.
● Strong knowledge of notifications related to GPSP.
● Project Management skills
● Excellent communication skills in both Japanese & English.
- 雇用形態
- Full-Time/正社員
- ポジション・役割
- Clinical Development Manager
- 勤務地
- Tokyo
- 年収・給与
- 13 million yen ～ 15.49 million yen
