運用サポート/ Operations Support

A global life sciences consulting company is looking for an Operations Support. The selected candidate will support regulatory documentation, inspection tracking, RTQ coordination, and EDMS updates across key lifecycle activities.

Responsibilities:

• Prepare MCN and PCA packages, including document compilation, formatting, template use, and basic completeness checks
• Maintain project timelines, task lists, and trackers for GMP inspections and FMA activities
• Track RTQ response owners, due dates, and status updates
• Register and update information in EDMS for MCN, PCA, approvals, GMP inspections, FMA, and lifecycle events

Requirements:

• 1-3 years of experience in an operations-oriented support role (operational support, coordination, administrative operations, shared services, or back-office operations within a pharmaceutical organisation)
• Proficient in IT
• Skilled in MS Office Suite
• Professional level Japanese; proficient in written English

About the Company:

A global leader in life sciences consulting, this company delivers regulatory, clinical, and quality solutions to support pharmaceutical, biotechnology, and medical device companies worldwide. Known for its innovative approach and deep domain expertise, it empowers job hunters to be part of impactful projects that advance healthcare and compliance on a global scale.

Keywords:

ライフサイエンス, 業務サポート, 薬事, 求人, 外資系

Job Ref: 4K940Q