Sr. Specialist, Data Review - R&D

Job Title: Sr. Specialist, Data Review – R&D InjectablesLocation: Cherry Hill, NJJob Type: Full-timeReq ID: 11160About Us:As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.Description: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, ORMaster’s degree in chemistry or closely related field with 3 years of FDA regulated cGMP analytical development or related laboratory experience, ORPh.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.What We Offer*:Annual performance bonus, commission, and share potentialAuto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contributeA generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries3 personal days (prorated based on hire date)11 company paid holidaysComprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefitsEmployee discount programWellbeing rewards programSafety and Quality is a top organizational priorityCareer advancement and growth opportunitiesTuition reimbursementPaid 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.Recruiters:Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.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.#LI-KJ1Job SummaryJob number: 11160Profession: Commercial, Sales & MarketingEmployment type: Full time