Inspection Readiness Lead for Clinical Trials & Compliance

Regeneron Pharmaceuticals, Inc (USA); Armonk (NY); On-site; USD 150,500 - 245,500; Full time

Benefits offered by this job

Annual bonuses

401(k) company match

Health and wellness programs

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Clinical Study Inspection Readiness to oversee GCP inspection activities for clinical programs. This role involves collaborating with program leaders and ensuring compliance with ICH/GCP guidelines.

The ideal candidate has over 8 years of clinical experience, strong project management skills, and proficiency in AI tools. The position offers a competitive salary and comprehensive benefits.

Qualifications

• 8+ years of relevant clinical experience.
• Clinical inspection experience strongly preferred.
• Knowledge of ICH guidelines and clinical trial documentation.
• Experience managing complex clinical portfolios.

Responsibilities

• Lead mock, dry‑run, and actual inspections.
• Guide and support Clinical Study Teams during inspections.
• Ensure Trial Master File (TMF) documentation is maintained.
• Manage inspection action items throughout their lifecycle.
• Utilize AI applications to enhance documentation.

Skills

Good Clinical Practice (GCP)

Project management

Communication skills

Stakeholder management

AI tools proficiency

Education

BS/BA degree

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Manager, Clinical Study Inspection Readiness to oversee GCP inspection activities for clinical programs. This role involves collaborating with program leaders and ensuring compliance with ICH/GCP guidelines.

The ideal candidate has over 8 years of clinical experience, strong project management skills, and proficiency in AI tools. The position offers a competitive salary and comprehensive benefits.