Hikma Pharmaceuticals · 2 days ago
Sr. Specialist, Data Review - R&D
Cherry Hill, NJ
Full-time
Onsite
Mid, Senior Level
$67K/yr - $134K/yr
3+ years expHikma Pharmaceuticals is committed to building a diverse and inclusive team and is seeking a talented and motivated Sr. Specialist, Data Review – R&D Injectables. In this role, you will be responsible for the critical review of pre-submission raw data and reports for regulatory submission to the US FDA, ensuring compliance and data integrity throughout the process.
Health CareMedicalPharmaceutical
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
Qualification
Required
Requires a 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
Proficient in MS Office applications (Word, Excel)
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
Must be a self-motivated, proactive team player with positive interaction with colleagues and stakeholders to ensure work ethics, teamwork, and discipline
Conduct oneself in a professional manner in alignment with corporate values
Ability to work and interact successfully in a global, diverse and dynamic environment
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
Benefits
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.
Company
Hikma Pharmaceuticals
Hikma focuses on a wide range of generic, branded generic and in licensed pharmaceutical products
5001-10000 employees
H1B Sponsorship
Hikma Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (23)
2023 (22)
2022 (24)
2021 (28)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
International Finance Corporation
2025-07-15Post Ipo Debt· $250M
2005-11-04IPO
Leadership Team
Said Darwazah
Chief Executive Officer
Khalid Nabilsi
Chief Financial Officer
Recent News
London Evening Standard
2025-12-16
2025-12-15
MarketScreener
2025-12-15
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