Senior Data Review Lead, R&D Injectables

RXinsider LTD.; Cherry Hill Township (NJ); On-site; USD 67,000 - 134,000; Full time

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Specialist, Data Review – R&D Injectables in Cherry Hill, NJ. The role focuses on critical review of pre-submission data and reports to ensure data integrity, reliability, and traceability for FDA submissions.

The position requires strong knowledge of cGMP, regulatory guidelines, and data management. Responsibilities include auditing AR&D documents, overseeing data quality, and coordinating with scientific staff to resolve issues.

Qualifications

• Bachelor’s degree in chemistry or closely related field and at least 5 years of FDA regulated cGMP analytical development or related laboratory experience, OR
• Master’s degree in chemistry or closely related field with 3 years of FDA regulated cGMP analytical development or related laboratory experience, OR
• Ph.D. in chemistry or closely related field and 2 years of FDA regulated cGMP analytical development or related laboratory experience.

Responsibilities

• Review pre-submission data and reports for regulatory submission to US FDA.
• Ensure data integrity, reliability, accuracy and traceability of submitted data.
• Audit regulatory pre-submission documents from AR&D and quality.
• Identify deviations, OOS and OOT in AR&D data.
• Issue review observations and coordinate with scientific staff.
• Report data integrity issues promptly to management.
• Complete audit tasks within timelines and maintain quality.
• Perform other duties as assigned by the manager.

Skills

FDA regulated cGMP

Analytical development

Data integrity

Project prioritization

Communication

Office software

Documentation review

Auditing

Attention to detail

Regulatory knowledge

Education

Bachelor's degree in chemistry or closely related field

Master's degree in chemistry or closely related field

Ph.D. in chemistry or closely related field

Tools

LIMS

Empower 3 CDS

Quality Management software

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Specialist, Data Review – R&D Injectables in Cherry Hill, NJ. The role focuses on critical review of pre-submission data and reports to ensure data integrity, reliability, and traceability for FDA submissions.

The position requires strong knowledge of cGMP, regulatory guidelines, and data management. Responsibilities include auditing AR&D documents, overseeing data quality, and coordinating with scientific staff to resolve issues.