• Perform statistical analysis by using Proc Print, Proc Means, Proc Freq, and Proc Report. Import raw data and create SAS data sets from flat files in formats like delimited, CSV, and XPT; Import techniques are used to generate datasets from raw set files, and set, merge, sort, update, formats, and functions are used to modify datasets.Experience in SAS/BASE, SAS/MACROS, SAS/EG, and SAS/ACCESS; Perform statistical analysis by Proc Gplot, Proc Mixed, and Proc Lifetest; Write SQL queries and stored procedures leveraging SQL passthrough, hash lookups, and format lookups; Develop SAS macros, templates, and utilities for data cleaning and reporting; Provide programming input to CRF, SAP, analysis file specifications, tables, figures, and listings (TLF) shells; Use SAS/ODS to generate XML, RTF, MS Excel, PDF, and HTML.

Skills: PROC PRINT, PROC MEANS, PROC FREQ, PROC REPORT, SAS/BASE, SAS/MACROS, SAS/EG, SAS/ACCESS, PROC GPLOT, PROC MIXED, PROC LIFETEST, SQL QUERIES, SAP, SAS/ODS, XML, and RTF.

Educational Qualification: Bachelor’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note: Must be willing to travel and/or relocate to work in unexpected locations across the United States.

• The clinical data manager is responsible for collecting data from clinical trials created for pharmaceuticals, biologics, or devices. ensures the data collected is accurate, groups the data properly, solves operational problems, and prepares statistical reports. Work with complex computerised record systems and maintain security and integrity. Collect data from clinical trials. Sort information and then ensure it’s screened, grouped, summarized, transcribed, and coded. Consult with other employees to solve operational or data problems. Provide clerical duties such as data entry, transcription, coding, and collating searches. Prioritize work in line with project management decisions. Manage clinical trials through the review, computerization, cleaning, and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines, and regulatory agency guidelines. Validate clinical trial data to ensure consistency, integrity, and accuracy based on project-specific guidelines. Generate data retrievals and summaries. Query the data for inconsistencies and revise the case report forms in compliance with standard operating procedures. Review the case report forms for completeness and consistency. Implement a strategy for data cleaning and the design and programming of clinical databases. Review and approve the design, data review ground rules, and database design according to standard operating procedures and protocol.

Skills: database/coding/computer skills; report writing; analytical; EDC, SAS, and CDISC.

Educational Qualification: Bachelor’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc., or in a healthcare or technology-related field.

Note:  Must be willing to travel and/or relocate to work in unexpected locations across the United States.

• The validation engineer is responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current good manufacturing practises (GMPs), and all other regulatory requirements, including GAMP5. executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages. compiles and analyses validation data, prepares reports, and makes recommendations for changes and/or improvements. may also investigate and troubleshoot problems that occur and determine solutions. coordinates and executes validation change control and the preparation of draught protocols, reports, and data tables. maintains all documentation pertaining to validation. will assist in developing procedures and/or protocols. coordinates contract personnel through the completion of assignments. participates on cross-functional project teams with the support of development, manufacturing, engineering, quality, and other groups as required. may provide day-to-day guidance and training to other validation technicians. serves as an information resource for validation technicians, contractors, and vendors. resolves validation issues of moderate scope with limited direct supervision. Understanding and application of validation principles, concepts, practices, and standards working knowledge of current good manufacturing practices (GMPs). Previous experience with Computer System Validation (CSV) and experience with the System Development Life Cycle of automated computer systems within biopharmaceutical environments Working knowledge of the validation of process control (PCS) and data acquisition systems is preferred.

Skills: Proficiency in Microsoft Office Suite or related software is required.

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note:  Must be willing to travel and/or relocate to work in unexpected locations across the United States. 

• The Drug Safety Associates are responsible for ensuring that drugs and other pharmaceutical products are safe to use. They commonly work in a laboratory setting, testing new drugs or reviewing existing ones to ensure that they meet quality standards. Drug safety associates may also be tasked with monitoring the effects of certain drugs on human subjects. This can include observing patients who are taking these drugs as part of clinical trials or performing tests on animals to determine how different substances interact with each other. Also, they are responsible for reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug. conducting site visits to observe the distribution process to ensure compliance with federal regulations. Performing clinical research studies involving human subjects in accordance with appropriate standards of ethics and safety Monitoring compliance with drug licensing laws and regulations ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions. preparing reports about the status of drug inventories and other pertinent information for management. suggesting methods to improve workflow processes within the pharmacy department. Administering medications to individuals according to established protocols Providing assistance in the investigation of medication errors or problems with drug labelling or packaging

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note:  Must be willing to travel and/or relocate to work in unexpected locations across the United States. 

• The Regulatory Affairs Associate independently prepares, reviews without appreciable direction, and submits high-quality regulatory submissions, such as ANDAs, to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.

• Compile and complete high-quality ANDAs and amendments, ensuring that the final submission meets the requirements of the USFSDA-recommended ANDA checklist to avoid any acceptance to file issues. Ensure all submissions and projects are completed within the expected timeline. maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. provides guidance and direction to junior employees.

• Coordinates with external vendors for project support activities. This may include, but is not limited to: RS statements, TSE/BSE statements, melamine-free certificates, cGMP certificates, debarment certificates, US agent letters, DMF Loa’s, Technical data sheets and technical drawings, quantitative compositions of colors, flavors, etc. Follow up with the purchase team for DMFs and compliance with DMF review comments. Organize and maintain submission components associated with a regulatory submission electronically. This may include scanning, converting to PDF, bookmarking, hyperlinking, electronic processing, and uploading to e-CTD Xpress, etc., independently. Reviews of ANDAs against Refuse-to-Receive (RTR) Standards Guidance to avoid deficiencies that may result in FDA RTRs—review includes a critical, detailed assessment that technical documentation and information is available, accurate, and complete for submission.provides guidance and direction to junior employees for the screening of ANDAs against the checklist. represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or resolve technical issues. Prepare and update the road map for each assigned product with committed timeliness by each department. Evaluate change controls and develop strategies for correct filing categories with the manager's guidance.Proactively brings major project issues, if any, to the manager's attention for resolution and agreement. Review the API DMFs thoroughly and share the review comments with the purchase department on time. Follow up with the purchase team or with the DMF holder directly as needed to ensure compliance with the provided comments.

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note:  Must be willing to travel and/or relocate to work in unexpected locations across the United States. 

• The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. The CTA also supports the study team by creating and distributing study team materials, tools, and documents. Creating and or reviewing study plans, specification documents, materials, and tools ability to communicate clearly, both verbally and in writing, to sites, vendors, CROs, the internal study team, etc. Track study progress in CTMS, including patient enrollment and patient status, and oversight of regulatory documents for site initiation. Provide access to systems when applicable. Track and ensure the training of the study team. QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert Acknowledgements, ICFs, and timelines Process and track payments to vendors and study sites as appropriate. Oversee TMF Quality Review for the study team and complete TMF QC for the department on a quarterly basis for each study. collecting, quality reviewing, and submitting documents to the TMF. TMF is subjected to quality control as needed. Support planning and logistics for meetings, including investigator meetings, study team meetings, and meetings with CROs and other vendors. Generate, finalize, and distribute study team agendas and meeting minutes. Assist with generating the CSR appendices and participate in SOP and WP development. Mentor and coach other CTAs, as appropriate, and participate in or provide leadership in departmental initiatives.

Skills: Computer skills (MS Office suite), CTMS (TW, Celtrak), familiarity with ICH/GGCP and regulatory guidelines and directives.

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note: Must be willing to travel and/or relocate to work in unexpected locations across the United States. 

• The Clinical Research Associates should assist in organising and monitoring the different stages of clinical trials. The following are other duties and responsibilities a clinical research associate should be able to execute: Supervise study sites and activities to ensure adherence to appropriate industry protocols and the terms of the study. Collect and authenticate data collection forms, otherwise known as case report forms. Screen potential study participants through medical record reviews, interviews, and follow-ups with healthcare providers. Coordinate with ethics committees to safeguard the rights, safety, and wellbeing of all research subjects and research activities. Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports, and consent forms. Prepare final reports, occasional manuscripts or publications, new drug applications (NDAs), and biological licence applications (BLAs). Ensure proper transmission of clinical case data to the data management centers, review case reports for questions and problems, and clarify or obtain alterations to the data as appropriate. Oversee research, technical, and administrative staff, to include training, hiring, goal setting, and the distribution of workload.

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note:  Must be willing to travel and/or relocate to work in unexpected locations across the United States. 

• The medical coder, or Certified Professional Coder, is responsible for reviewing a patient’s medical records after a visit and translating the information into codes that insurers use to process claims from patients. accounts for the coding and abstracting of patient encounters, including diagnostic and procedural information, significant reportable elements, and complications. investigates and analyses data requirements for reimbursementanalyses medical records and identifies documentation deficiencies. serves as a resource and subject matter expert to other coding staff. reviews and verifies documentation that supports diagnoses, procedures, and treatment results. identifies diagnostic and procedural information. Audits of clinical documentation and coded data to validate documentation support services rendered for reimbursement and reporting purposes. assigns codes for reimbursements, research, and compliance with regulatory requirements utilising guidelines. follows coding conventions. serves as a coding consultant to care providers. identifies discrepancies, potential quality of care, and billing issues. researches, analyzes, recommends, and facilitates a plan of action to correct discrepancies and prevent future coding errors. identifies reportable elements, complications, and other procedures. serves as a resource and subject matter expert to other coding staff. assists the lead or supervisor in orienting, training, and mentoring staff. provides ongoing training to staff as needed. handles special projects as requested.

Skills: Administrative writing, reporting skills; organizational skills; record-keeping; Microsoft Office skills; professionalism; confidentiality; organization; typing; verbal communication.

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Note: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.

• The application developer should be responsible for Developing software solutions to meet customer needs Creating and implementing the source code of new applications Testing source code and debugging code evaluating existing applications and performing updates and modifications. Developing technical handbooks to represent the design and code of new applications Work collaboratively with the team to receive and respond to project requests. Investigate potential programming requirements and programming languages. Provide programming experience to creatively design software. Utilize industry-accepted testing methods to troubleshoot flaws. Work with different teams and departments to ensure code quality. Create reports and present development updates to teams and stakeholders. Customize existing code to ensure efficiency and functionality. Accurately document programming and code changes.

Educational Qualification: Bachelor's or Master’s degree or equivalent, preferably in a scientific discipline such as statistics, computer science, mathematics, etc. healthcare or technology-related field.

Requirement: Must be willing to travel and/or relocate to work in unexpected locations across the United States.