R8035 • Applications development
Washington, DC • Full-Time
The Application Systems Analyst IV focuses on full life-cycle management of requirements and specifications, User Acceptance Testing (UAT) support and user training support for the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS). This position is directly responsible for developing system specifications from the provided business requirements (including associated LOEs for development), as well as tracking those requirements throughout the design, development, testing, and implementation phases. An Application Systems Analyst IV must be able to apply professional knowledge to resolve complex issues where analysis of situations or data requires an in depth evaluation of variable factors.
Chickasaw Nation Industries, Inc. serves as a holding company with multiple subsidiaries engaged in several lines of business (Technology, Infrastructure & Engineering, Health, Manufacturing, Public Safety, Consulting, and Transportation) for the federal government and commercial enterprises. A portion of our profits is used to support Chickasaw citizens. We are proud to support the economic development and long-term viability of the Chickasaw Nation and its people. CNI offers premium benefits eligible on the first day of hire to full time employees; (Medical - Dental – Vision), Company Life Insurance, Short-Term and Long-Term Disability Insurance, 401(K) Immediate Vesting, Professional Development Assistance, Legal Aid Assistance Program, Family Planning / Fertility Assistance, Personal Time Off, and Observance of Federal Holidays.
As a federal contractor, CNI is a drug-free workplace and adheres to the Federal Controlled Substance Act.
ESSENTIAL REQUIREMENTS
The ability to obtain, maintain and access classified information at the Public Trust level.
Specialized knowledge and advanced skills in the tools, concepts, practices and procedures of application systems
Advanced knowledge and understanding of design applications using computer modeling, simulation, and optimization
Expert computer skills with advanced proficiency in a Windows based computer environment
Excellent analytical and problem-solving skills with ability to develop and follow through on creative solutions
Excellent verbal and written communications skills with ability to organize, document, present and explain information
Ability to clearly and concisely communicate / explain technical information to a broad range of people with varying levels of technical expertise
Exceptional customer service skills with ability to respond to requests in a professional, helpful and timely manner
Excellent project management skills necessary to facilitate conference calls, manage projects and coordinate deliverables
Exceptional organization skills with ability to effectively manage multiple projects and priorities
Ability to carry out day-to-day responsibilities and meet specified deadlines
Ability to effectively work both independently and in a team environment for the successful achievement of goals
Ability to adhere to regularly-scheduled business hours
Has experience in working on Pharmacovigilance IT projects with hands on experience for data mappings, data-analysis and identification.
Must be aware of Federal regulations for case compliance, safety surveillance and must be familiar with CFR mandates released for post-market adverse event reporting in the last 6-7 years.
Preferably have experience on FDA’s CDER (Drug) and CBER (biologic) product reporting guidance.
Must be aware of pharmacovigilance changes coming up for the industry for pre-market initiatives in the HL7 R3 space.
Must be aware of Product quality submission guidelines along with expertise on existing FAR, BPDR form regulations.
Must be familiar with MedDRA upgrade life cycles and process through automation.
General awareness of industry standards in support of Pharmacovigilance processes is ideal.
KEY DUTIES AND RESPONSIBILITIES
Essential Duties and responsibilities include the following. Other duties may be assigned.
Oversees projects from analysis through implementation. May support multiple projects while maintaining support of day to day business.
Serves as the department and client representative. Coordinates projects between Client Services and IT.
Provides weekly or daily technical system setup status reports to team and client, as needed.
Reviews, analyzes and evaluates business systems and client needs. Works directly with client and account managers to develop requirements for system development efforts and detailed technical specifications.
Writes test and use cases, and drives quality assurance through System and User Acceptance Testing.
Prepares and documents functional and technical specifications.
Works with IT and business project teams to understand reporting requirements and to propose solutions.
Documents and provides knowledge transfer to the Project Team for all solutions.
Analyzes divisional procedures to identify areas for automation, process improvement, etc.
Conducts ad-hoc reporting for Sales, Account and Operations Managers.
Formulates systems to parallel overall business strategies.
Trains users on the use of new programs. Provides technical assistance when required.
Develops and maintains documentation for both new and existing client business and system processes.
Prepares test scripts and performs / documents QA testing. Performs root cause analysis.
Coordinates and facilitates meetings with technical team and end-users (SMEs).
Proactively remains up-to-date with new technologies and new ways to develop programs by reading professional publications such as manuals, periodicals and technical reports.
EDUCATION AND EXPERIENCE
Bachelor’s degree in Computer Science, Computer Information Systems, Business Management or a related field of study and a minimum of eight (8) years' professional business analysis experience, preferably with a software solutions focus. Exposure and experience in working on EPLC Project is preferred.
PHYSICAL DEMANDS
Work is primarily performed in an office environment. Regularly required to sit. Regularly required use hands to finger, handle, or feel, reach with hands and arms to handle objects and operate tools, computer, and/or controls. Required to speak and hear. Occasionally required to stand, walk and stoop, kneel, crouch, or crawl. Must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus. Exposed to general office noise with computers printers and light traffic.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
EOE including Disability/Vet
*Please note, that this position is contingent upon the award or funding. The essential duties, experience, education requirements, and salary are subject to change.*
The estimated pay range for this role is $125K to $150K, with the final offer contingent on location, skillset, and experience.
CNI offers a comprehensive benefits package that includes:
Medical
Dental
Vision
401(k)
Family Planning/Fertility Assistance
STD/LTD/Basic Life/AD&D
Legal-Aid Program
Employee Assistance Program (EAP)
Paid Time Off (PTO) – (11) Federal Holidays
Training and Development Opportunities
Your application submission will be considered for all potential employment opportunities with Chickasaw Nation Industries (CNI).
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