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Application Systems Analyst IV
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. 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
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
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).