Sr. Specialist, Data Review - R&D

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

Job Title: Sr. Specialist, Data Review – R&D Injectables

Location: Cherry Hill, NJ

Job Type: Full-time

Req ID: 11160

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Specialist, Data Review – R&D Injectables.

In this role, you will be responsible for and accountable for the critical review of pre-submission raw data and reports ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission data and reports by using department SOPs and analytical methods to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.

Key Responsibilities

• Ensures compliance with cGMP and good documentation procedure during the review process.
• Audits regulatory pre-submission documents from the Analytical Research and Development (AR&D) and quality.
• Perform AR&D technical, scientific, and compliance review of data and documentation generated by the AR&D group in support of regulated studies.
• Identify deviations, OOS and OOT associated with AR&D data as applicable.
• Issue AR&D review observations and work closely with the scientific staff to ensure data integrity.
• Informs the manager immediately of any critical data integrity issues or data irregularity.
• Completes the audit tasks within the specified timeframe without compromising the quality of the audit.
• Performs any other responsibilities which are required as assigned by the manager.

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• 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.
• Knowledge in pharmaceutical cGMP requirements, ICH/US FDA guidelines, Laboratory test procedures, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures, method validation protocols/reports, COAs, product development reports, and Quality overall summaries.
• Knowledge in pharmaceutical analytical technologies.
• Proficiency in LIMS, Empower 3 CDS and Quality Management software packages.
• Ability to monitor, coordinate and prioritize work in an effective and efficient manner, with capacity to manage simultaneous projects within a set timeline; ability to continuously make an assessment of the workload and suggest any support required on need basis.
• Demonstrates excellent interpersonal communication skills: verbal, written and presentation skills.
• Expert computer skills with the ability to enter data into and retrieve information from various software programs such as Microsoft Office Suite programs Word, Excel, PowerPoint, and Outlook.

Compensation

Base Salary: $66,600.00 to $133,750.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.