Junior Analyst

Job Title: Junior Analyst – FDA DASH Regulatory Data / Database Curation
US CITIZEN ONLY
Client: U.S. Food and Drug Administration (FDA) – CDER / Office of Translational Sciences
Location: Remote with occasional onsite support in Silver Spring, MD / Washington, DC area
Duration: 12 Months – Contingent Upon Contract Award
Pay Rate: $44.27–$46.15/hour
Position Type: Key Personnel / Government Contract
Clearance: Must be able to obtain required FDA suitability, including NACI and Level 5 Public Trust processing
Anticipated Start: Upon contract award and completion of applicable onboarding/security requirements

Job Summary

SMX Services & Consulting is seeking a Junior Analyst to support the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Office of Translational Sciences, on the Data Analysis Search Host (DASH) Knowledge Management program.

The Junior Analyst will support the collection, interpretation, standardization, entry, maintenance, curation, and quality assurance of regulatory science data contained in FDA's DASH database.

The role requires strong attention to detail and the ability to accurately review complex FDA and sponsor-submitted regulatory documentation, identify required data elements, standardize those data according to established procedures, and enter validated information into database systems.

FDA specifically values candidates who already understand CDER's new drug review process and have experience with FDA regulatory documentation, FDA systems, pharmaceutical data, or the DASH database.

Responsibilities

• Review electronic and paper FDA regulatory submissions and supporting documentation.
• Identify and extract required regulatory and scientific information from source documents.
• Interpret, standardize, and format data according to established specifications and business rules.
• Enter collected information into the FDA DASH database.
• Work with FDA and proprietary systems containing drug-review and regulatory information.
• Perform data analysis and data-standardization activities.
• Use Microsoft Excel, spreadsheets, and database applications to manage and validate information.
• Perform data-quality checks and quality-assurance reviews.
• Review newly entered application records for accuracy, consistency, and completeness.
• Maintain QA/QC records and supporting documentation.
• Identify inconsistencies or questions and escalate them to FDA DASH subject-matter experts.
• Follow established DASH standard operating procedures, data definitions, and data-entry protocols.
• Support updates to database documentation, SOPs, data definitions, user guides, and related resources.
• Participate in FDA training and knowledge-transfer activities.
• Work collaboratively with FDA subject-matter experts, technical personnel, and other contractors.
• Protect sensitive, proprietary, CUI, PII, and non-public FDA information.

The underlying DASH work includes regulatory-data collection, entry, maintenance, curation, standardization and QA/QC.

Required Qualifications

• BA or BS degree required.
• 2+ years of professional experience.
• Experience with data standardization and analysis.
• Experience using Microsoft Excel and/or database software.
• Strong attention to detail.
• Strong analytical and data-quality skills.
• Ability to interpret detailed technical or scientific information.
• Ability to follow established processes, SOPs, and data standards.
• Ability to communicate questions, risks, and data discrepancies promptly.
• Ability to meet FDA security and suitability requirements.

The BA/BS, 2+ years of experience, data-standardization/analysis experience, and spreadsheet/database capability are direct SOW §10.2 requirements.

FDA/CDER Experience — Strongly Desired

Candidates with the following backgrounds should be prioritized:

• Familiarity with the FDA CDER new drug review process.
• Hands-on experience with FDA new-drug-review IT systems.
• Experience reviewing FDA or sponsor-submitted regulatory documents.
• Knowledge of IND, NDA, BLA, and efficacy-supplement documentation.
• Pharmaceutical, biomedical, clinical-trial, or regulatory-science experience.
• Life-sciences and/or statistical experience.
• Experience extracting regulatory data from scientific documents.

FDA's evaluation gives significant emphasis to personnel knowledge of CDER's new-drug-review process, regulatory documentation and FDA systems.

Highly Preferred

Direct FDA DASH experience, including one or more of:

• DASH database data entry
• DASH data curation
• DASH quality-assurance procedures
• DASH SOPs
• DASH data definitions/business rules
• DASH regulatory-document review

Direct DASH experience is expressly identified as highly preferred by the solicitation.

Security Requirements

Candidate must be capable of completing:

• National Agency Check Inquiry (NACI)
• Level 5 Public Trust processing, including fingerprinting
• FDA security and privacy training
• FDA nondisclosure/non-public-information requirements
• Required protection of sensitive FDA information

The RFQ expressly requires NACI and Level 5 Public Trust processing for contractor staff.

Work Location

Work is expected to be performed primarily through remote electronic access to the FDA intranet. Occasional travel to FDA offices in the Washington, DC area may be required, and the kickoff meeting is planned for the FDA White Oak Campus in Silver Spring, Maryland.

Pay Rate: $44.27–$46.15/hour

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