Job Description

• Enter data into Oracle APEX-based systems using dropdowns, validation tools, and standardized formats.
• Review regulatory documents (e.g., NDA, BLA, IND submissions) to extract key data elements.
• Interpret and standardize terminology using predefined vocabularies such as MedDRA and WHO Drug.
• Collaborate with FDA subject matter experts (SMEs) to resolve any unclear or ambiguous data entries.
• Maintain accurate records and participate in data quality activities including peer review and self-audits.
• Scan and digitize paper documents using FDA-provided hardware.
• Assist in documenting challenges and suggesting improvements to SOPs and workflows.
• Communicate regularly with teammates and FDA personnel to ensure smooth data entry operations.

• Bachelor’s degree or certification in Life Sciences, Public Health, Regulatory Affairs, Biomedical Science, or related field (or in progress).
• 1–3 years of experience in a Business Analyst, data entry, or research support role (internships may be considered).
• Strong attention to detail and comfort working with structured data.
• Familiarity with regulatory or clinical documentation preferred.
• Experience with Microsoft Excel and PDF tools (Adobe); Oracle APEX or other data capture systems a plus.
• Understanding of biomedical or pharmaceutical terminology is a plus, but not required.
• Clear written and verbal communication skills.

• Eager to learn regulatory systems and FDA processes.
• Comfortable working in a fast-paced, detail-oriented environment.
• Interested in public health, life sciences, or regulatory data.

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