Application Systems Analyst R8035

Chickasaw Nation Industries • Rockville, MD

112d • $120,000 - $140,000

About The Position

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.

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.
• Experience in working on Pharmacovigilance IT projects with hands-on experience for data mappings, data-analysis and identification.
• Awareness of Federal regulations for compliance, safety surveillance and familiarity 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.
• Awareness of pharmacovigilance changes coming up for the industry for pre-market initiatives in the HL7 R3 space.
• Awareness of Product quality submission guidelines along with expertise on existing FAR, BPDR form regulations.
• Familiarity with MedDRA upgrade life cycles and process through automation.
• General awareness of industry standards in support of Pharmacovigilance processes.

Nice To Haves

• Exposure and experience in working on EPLC Project is preferred.

Responsibilities

• Oversees projects from analysis through implementation.
• 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.

Benefits

• Medical
• Dental
• Vision
• 401(k) Immediate Vesting
• Professional Development Assistance
• Legal Aid Assistance Program
• Family Planning / Fertility Assistance
• Personal Time Off
• Observance of Federal Holidays
• Short-Term and Long-Term Disability Insurance
• Company Life Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree