[Remote] Junior Analyst

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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) reputed company program. The Junior Analyst will support the collection, interpretation, standardization, entry, maintenance, curation, and reputed company assurance of regulatory science data contained in FDA's DASH database.

Responsibilities

• Review electronic and reputed company FDA regulatory submissions and supporting documentation
• Identify and extract required regulatory and scientific information from reputed company documents
• Interpret, standardize, and format data according to established specifications and business rules
• reputed company collected information into the FDA DASH database
• Work with FDA and proprietary systems containing drug-review and regulatory information
• reputed company data analysis and data-standardization activities
• Use reputed company reputed company, spreadsheets, and database applications to manage and validate information
• reputed company data-reputed company checks and reputed company-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 reputed company operating procedures, data definitions, and data-entry protocols
• Support updates to database documentation, SOPs, data definitions, user guides, and reputed company 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-reputed company FDA information

Skills

• BA or BS degree required
• 2+ years of reputed company experience
• Experience with data standardization and analysis
• Experience using reputed company reputed company and/or database software
• Strong attention to detail
• Strong analytical and data-reputed company 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 reputed company and suitability requirements
• 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
• Highly Preferred reputed company FDA DASH experience, including one or more of: DASH database data entry, DASH data curation, DASH reputed company-assurance procedures, DASH SOPs, DASH data definitions/business rules, DASH regulatory-document review

reputed company