Junior Programmer

Junior Programmer – FDA DASH Database / Project Support

SMX Services & Consulting is seeking a Junior Programmer to support FDA CDER's DASH Knowledge Management program.

This position combines database/technical support with significant project coordination, quality management, schedule oversight, issue resolution, and project-management responsibilities. The FDA's stated qualifications for this labor category emphasize successful project completion, assignment of responsibilities, progress monitoring, quality standards, and administrative/contractual compliance.

Responsibilities

• Coordinate project activities and support timely completion of assigned work.
• Monitor project schedules, milestones, tasks, and deliverables.
• Assist with setting deadlines and coordinating responsibilities.
• Track and summarize project progress.
• Identify issues affecting successful delivery and coordinate resolution.
• Establish and reinforce quality work standards.
• Monitor compliance with project, administrative, and contractual requirements.
• Support development and maintenance of the Project Work Plan.
• Support project kickoff activities.
• Participate in bi-weekly FDA status meetings.
• Track deliverables, action items, risks, next steps, and anticipated issues.
• Support database-enhancement and process-improvement activities.
• Coordinate with FDA technical specialists, subject-matter experts, consultants, and other contractors.
• Support modifications to data processes, procedures, database fields, documentation, and related workflows.
• Assist with maintenance of SOPs, data definitions, user guides, SharePoint tracking materials, and project documentation.
• Support change-control and documentation activities.
• Maintain compliance with FDA security and confidentiality requirements.

FDA requires project oversight, a Project Work Plan and bi-weekly status updates under Task Area 3.

Required Qualifications

• BA or BS degree required.
• 4+ years of professional experience.
• 2+ years of management experience.
• Experience coordinating and completing projects on schedule.
• Experience overseeing project activities.
• Experience establishing deadlines and assigning responsibilities.
• Experience monitoring and summarizing project progress.
• Experience establishing and communicating quality work standards.
• Proven ability to identify and resolve issues affecting successful delivery.
• Proven ability to ensure compliance with administrative and contractual requirements.

These are the express minimum requirements under SOW §10.1.

Preferred Qualifications

• Federal or State Government experience.
• FDA/CDER experience.
• Familiarity with the CDER new-drug-review process.
• Experience working with regulatory documents.
• Database management or database-development experience.
• Oracle/APEX relational database experience.
• Experience with complex queries and relational data.
• Pharmaceutical, biomedical, regulatory-science, or health-data environments.
• Data-quality and QA/QC experience.
• Change-management and formal change-control experience.
• Experience maintaining SOPs, technical documentation, and project documentation.

Oracle/APEX, regulatory science, biomedical knowledge, and CDER system experience are specifically important elements of FDA's technical evaluation.

Highly Preferred

• Previous FDA DASH experience.
• Hands-on DASH database support.
• Experience with FDA proprietary drug-review systems.
• Experience interpreting FDA regulatory or sponsor-submitted documents.

Security Requirements

Candidate must be able to complete:

• NACI
• Level 5 Public Trust processing
• Fingerprinting
• FDA security/privacy training
• Required NDA/non-public-information agreements

Work Location

Primarily remote, with potential occasional onsite work at FDA facilities in the Washington, DC area. FDA identifies the White Oak Campus in Silver Spring, Maryland for the kickoff meeting.

Pay Rate: $54.35–$56.66/hour

This position is contingent upon SMX contract award and FDA acceptance of the proposed candidate.