Senior Data Review Specialist, Regulatory Submissions

Hikma Pharmaceuticals; Cherry Hill Township (NJ); Sur place; USD 66 000 - 134 000; Plein temps

Avantages offerts par ce poste

Annual bonus

401(k) with company match

PTO 20 days

Personal days

11 company paid holidays

Health, dental, vision

Life insurance

Employee discount

Wellbeing rewards

Tuition reimbursement

Parental leave

Résumé du poste

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, seeks a Sr. Specialist, Data Review – R&D Injectables to lead the critical review of pre-submission data for regulatory filings. You will ensure Data Integrity, Reliability, Accuracy, and Traceability of submitted data under cGMP and SOP guidelines.

The role requires expert knowledge of FDA/ICH guidelines, AR&D data, and collaboration with scientific staff to resolve deviations and ensure timely, compliant submissions.

Qualifications

• Bachelor’s degree in chemistry or closely related field with 5+ years of FDA regulated cGMP analytical development experience.
• Master’s degree in chemistry or closely related field with 3+ years of FDA regulated cGMP analytical development experience.
• Ph.D. in chemistry or closely related field with 2+ years of FDA regulated cGMP analytical development experience.
• Knowledge of pharmaceutical cGMP requirements, ICH/US FDA guidelines, and analytical method validation.
• Knowledge of pharmaceutical analytical technologies.
• Proficiency in LIMS, Empower 3 CDS and Quality Management software packages.
• Strong communication skills and ability to manage multiple projects.

Responsabilités

• Ensures cGMP and good documentation procedure during the review process.
• Audits regulatory pre-submission documents from AR&D and quality.
• Performs AR&D technical, scientific, and compliance review of data for regulated studies.
• Identifies deviations, OOS and OOT in AR&D data.
• Issues AR&D review observations and coordinates with scientific staff to ensure data integrity.
• Informs the manager immediately of any critical data integrity issues.
• Completes audit tasks within the specified timeframe without compromising quality.
• Performs additional responsibilities as assigned by the manager.

Connaissances

cGMP compliance

Analytical data review

Regulatory knowledge (FDA/ICH)

Data integrity

Project/workload management

Communication skills

Microsoft Office proficiency

Formation

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

Outils

LIMS

Empower 3 CDS

Quality Management software

Description du poste

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, seeks a Sr. Specialist, Data Review – R&D Injectables to lead the critical review of pre-submission data for regulatory filings. You will ensure Data Integrity, Reliability, Accuracy, and Traceability of submitted data under cGMP and SOP guidelines.

The role requires expert knowledge of FDA/ICH guidelines, AR&D data, and collaboration with scientific staff to resolve deviations and ensure timely, compliant submissions.