Regulatory Data Technical Advisor

BryceTech

Regulatory Data Technical Advisor in biotechnology and biopharmaceuticals at BryceTech. Focus on data quality and compliance in support of BARDA's nonclinical research initiatives.

Posted 5/19/2026full-timeRemote • District of Columbia, Washington • 🇺🇸 United StatesSeniorLeadWebsite

About the role

Key responsibilities & impact

Serve as technical SME for CDISC SEND and SENDIG-AR (2019)
Develop validation criteria, business rules, and quality control procedures for DCC ingestion of SEND datasets
Support design and implementation of DCC data architecture and metadata governance frameworks
Establish data acceptance and rejection criteria aligned with regulatory expectations
Contribute to DCC end user interface testing and acceptance criteria
Assist in developing end user training and implementation plans
Ensure alignment with Animal Rule regulatory requirements (21 CFR 314.600 and 601.90)
Assist other contractors by translating regulatory requirements into operational data standards specifications
Perform quality control of dataset packages
Integrate knowledge of nonclinical study conduct to assure correct dataset output
Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages
Communicate findings to team members and management
Obtain proficiency with DNCD quality control workflows to include regulatory dataset [e.g. SEND] review, study report QC, and other reviews, as required
Adhere to and/or assist in establishment/refinement of DNCD SOPs and business practice documents related to QC efforts
Learn data audit practices with possibility to assist in remote and/or on-site data audits of BARDA contracted research
Provide technical expertise to individual advanced research and development (ARD) and/or nonclinical project coordination teams (PCTs)
Act as the primary data management contact for BARDA ARD/nonclinical PCTs supporting contracts issued to CHEM, RADNUC, and BIOLOGICAL network contract research laboratories (CROs)
Coordinate with PCTs to determine intended use for data derived from contract(s) and establish data management plans intended to ensure data are fit for purpose
Coordinate with PCTs to ensure data management plans are included within contract management plans and quality assurance project plans established by CRO contractors
Develop strong PCT relationships that are driven by consistent study data analytic and management services in terms of quality and timeliness
Advise CRO contractors on data delivery and format requirements
Receive and review raw data from CRO contractors for completeness and quality according to established quality control standards
Coordinate with BARDA statisticians for appropriate methods and practices related to analytical support to PCTs

Requirements

What you’ll need

Advanced degree (e.g., Ph.D., M.P.H., M.S.) in biological and/or chemical sciences such as medicine, pharmacy, life science fields (e.g., immunology, molecular biology, biochemistry, microbiology, or similar)
Minimum eight (8) years of relevant industry and/or relevant postdoctoral experience in regulatory data standards and analytics
Direct SEND implementation experience
Client-focused approach to work; Ability to prioritize workload in a hybrid/remote work environment

Benefits

Comp & perks

competitive salary
comprehensive health plan including dental and vision coverage
company-paid life & disability insurance policies
401(k) plan with company match
educational reimbursement program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CDISC SENDSENDIG-ARdata architecturemetadata governancequality controldata managementdata acceptance criteriadata audit practicesregulatory dataset reviewdata analytics

Soft Skills

client-focusedprioritizationcommunicationcollaborationrelationship buildingtroubleshootingtraining developmentteamworkadaptabilityproblem-solving

Certifications

Ph.D.M.P.H.M.S.