PMS企画・運営リード/ PMS Planning & Operations Lead

A global biopharmaceutical company is seeking a PMS Planning & Operations Lead. The selected candidate will develop and execute PMS strategies to align with regulatory requirements and maximise product value.

Responsibilities:

• Develop PMS strategies aligned with RMP and regulatory authority agreements
• Oversee PMS activities to ensure timely, high-quality, and cost-effective study execution
• Ensure inspection readiness through risk management and CAPA implementation
• Manage and monitor external CROs to secure reliable execution and expanded services
• Collaborate with internal teams to deliver rapid and efficient data management
• Build and maintain relationships with regulatory bodies, industry associations, and key opinion leaders

Requirements:

• Bachelor’s degree or equivalent is ideal
• More than 3 years of experience in interventional or non-interventional study design or oversight of execution operations
• More than 3 years of experience in the pharmaceutical industry
• Knowledge of pharmaceuticals and medical devices law, GPSP/GVP/ GCP and
  SOPs, and applicable to clinical and post marketing areas
• Proficient in English (TOEIC 700+) is ideal

About the Company:

An international biopharmaceutical company with a wide portfolio of products that support the treatment and prevention of various diseases. The company has been widely recognised for its medicine.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: 41XK7S