DRT Strategies
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Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries. Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description
The Food and Drug Administration’s is seeking contractor support to help manage and improve systems used for electronic. The overall goal is to keep these systems reliable and up-to-date as regulatory requirements and technology evolve. The contractor will provide expertise on regulations and technical issues, support testing and implementation of new standards (like updates to electronic submission formats), deliver ongoing help desk and training services, and assist with daily operations. The work will also involve managing user questions, supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will help the FDA meet its obligations under recent legislation and ensure that its electronic submission platforms remain effective and secure.
Job Summary
The Functional Analyst will support a lead in analyzing business needs, documenting processes, and ensuring compliance with FDA requirements for electronic submissions and data management. This position works closely with business and technical teams to validate, review, and continuously improve the intake and analysis of study data for human drug applications. Responsibilities include supporting the implementation and testing of data standard updates, performing data quality assessments, preparing technical documentation, and helping coordinate stakeholder requirements to streamline regulatory review and enable ongoing enhancement of FDA submission processes.
Responsibilities
Support a Lead in analyzing business needs, documenting processes, and ensuring alignment with FDA electronic submission and data management requirements. Participate in the development and implementation of solutions by leveraging expertise in regulatory data standards, electronic submissions, and study data management. Document and map business processes related to human drug data submission, intake, validation, and review, ensuring compliance with FDA policies and industry standards. Gather, analyze, and document requirements for updates to study data-based validations in validation tools, collaborating with business and technical stakeholders. Support validation and testing activities for new and updated electronic submission tools, including preparing test data, developing test scripts, and conducting acceptance testing. Identify, document, and analyze tool deficiencies and process gaps; perform root cause and impact analysis, and propose enhancements to improve data intake and review processes. Contribute to the continuous improvement of study data intake, validation, and analysis processes by recommending and supporting the implementation of process enhancements and published data standards. Assist in the integration of study data with analytical and review tools, ensuring seamless data flow and supporting scientific review activities. Perform data profiling and quality assessments of non-clinical and clinical study data to identify deficiencies impacting regulatory review, and support remediation efforts. Prepare and maintain technical documentation, including requirements, test cases, standard operating procedures (SOPs), FAQs, and knowledge base articles. Monitor industry trends, policy changes, and best practices in electronic submissions and data management, and assess their impact on FDA processes and systems. Direct and coordinate activities of staff as necessary, providing guidance and oversight on tasks related to electronic submission support, validation, and process improvement. Participate in meetings, facilitate discussions, and communicate findings to stakeholders, including FDA staff, contractors, and external partners. Support help desk operations by triaging, documenting, and resolving user inquiries related to electronic submissions, and escalating complex issues as needed. Ensure compliance with security, privacy, and quality assurance requirements as outlined in FDA policies and the Statement of Work. Contribute to project deliverables such as progress reports, data profiling analyses, implementation roadmaps, and final project documentation.
Require Experience:
3–5 years of experience as a Functional Analyst, Business Analyst, or in a similar role supporting regulatory, data management, or electronic submission projects Demonstrated experience with FDA electronic submission standards and processes, and data standards Experience gathering, analyzing, and documenting business and technical requirements for system enhancements, process improvements, or validation tools Experience supporting validation, testing, and implementation of COTS tools or regulatory data management systems Strong analytical, problem-solving, and communication skills, including the ability to document processes, prepare reports, and present findings to stakeholders Experience providing Tier 1 and Tier 2 support for technical or regulatory help desks, including issue triage, resolution, and escalation
Preferred Experience:
Experience supporting FDA or other federal regulatory agencies in electronic submission, data standards, or informatics modernization projects Familiarity with industry data standards such as CDISC, SEND, HL7, and experience with study data validation and profiling Experience with process improvement initiatives in a regulatory or scientific data environment. Experience developing and delivering training materials or user support documentation for regulatory systems Proficiency with tools such as Microsoft Excel, SharePoint, Outlook, and specialized FDA systems Project management or Agile methodology experience is a plus.
Education & Training:
Bachelor’s degree in a relevant field such as Business, Information Systems, Computer Science, Life Sciences, or a related discipline.
Salary Range:
$60,000-$80,000 Salary commensurate with experience.
Company Benefits:
DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).
EEO Commitment
DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and qualified applicants for employment without regard to race, color, creed, religion, national origin, gender, sexual orientation, age, gender identity, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local laws.
Reasonable accommodation for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing [email protected], or by dialing 571-482-2517.
DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).
Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at hr@drtstrategies.com if you believe you have received a fraudulent email. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Business Development and Sales Industries IT Services and IT Consulting Referrals increase your chances of interviewing at DRT Strategies by 2x Sign in to set job alerts for “Functional Analyst” roles.
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DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries. Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description
The Food and Drug Administration’s is seeking contractor support to help manage and improve systems used for electronic. The overall goal is to keep these systems reliable and up-to-date as regulatory requirements and technology evolve. The contractor will provide expertise on regulations and technical issues, support testing and implementation of new standards (like updates to electronic submission formats), deliver ongoing help desk and training services, and assist with daily operations. The work will also involve managing user questions, supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will help the FDA meet its obligations under recent legislation and ensure that its electronic submission platforms remain effective and secure.
Job Summary
The Functional Analyst will support a lead in analyzing business needs, documenting processes, and ensuring compliance with FDA requirements for electronic submissions and data management. This position works closely with business and technical teams to validate, review, and continuously improve the intake and analysis of study data for human drug applications. Responsibilities include supporting the implementation and testing of data standard updates, performing data quality assessments, preparing technical documentation, and helping coordinate stakeholder requirements to streamline regulatory review and enable ongoing enhancement of FDA submission processes.
Responsibilities
Support a Lead in analyzing business needs, documenting processes, and ensuring alignment with FDA electronic submission and data management requirements. Participate in the development and implementation of solutions by leveraging expertise in regulatory data standards, electronic submissions, and study data management. Document and map business processes related to human drug data submission, intake, validation, and review, ensuring compliance with FDA policies and industry standards. Gather, analyze, and document requirements for updates to study data-based validations in validation tools, collaborating with business and technical stakeholders. Support validation and testing activities for new and updated electronic submission tools, including preparing test data, developing test scripts, and conducting acceptance testing. Identify, document, and analyze tool deficiencies and process gaps; perform root cause and impact analysis, and propose enhancements to improve data intake and review processes. Contribute to the continuous improvement of study data intake, validation, and analysis processes by recommending and supporting the implementation of process enhancements and published data standards. Assist in the integration of study data with analytical and review tools, ensuring seamless data flow and supporting scientific review activities. Perform data profiling and quality assessments of non-clinical and clinical study data to identify deficiencies impacting regulatory review, and support remediation efforts. Prepare and maintain technical documentation, including requirements, test cases, standard operating procedures (SOPs), FAQs, and knowledge base articles. Monitor industry trends, policy changes, and best practices in electronic submissions and data management, and assess their impact on FDA processes and systems. Direct and coordinate activities of staff as necessary, providing guidance and oversight on tasks related to electronic submission support, validation, and process improvement. Participate in meetings, facilitate discussions, and communicate findings to stakeholders, including FDA staff, contractors, and external partners. Support help desk operations by triaging, documenting, and resolving user inquiries related to electronic submissions, and escalating complex issues as needed. Ensure compliance with security, privacy, and quality assurance requirements as outlined in FDA policies and the Statement of Work. Contribute to project deliverables such as progress reports, data profiling analyses, implementation roadmaps, and final project documentation.
Require Experience:
3–5 years of experience as a Functional Analyst, Business Analyst, or in a similar role supporting regulatory, data management, or electronic submission projects Demonstrated experience with FDA electronic submission standards and processes, and data standards Experience gathering, analyzing, and documenting business and technical requirements for system enhancements, process improvements, or validation tools Experience supporting validation, testing, and implementation of COTS tools or regulatory data management systems Strong analytical, problem-solving, and communication skills, including the ability to document processes, prepare reports, and present findings to stakeholders Experience providing Tier 1 and Tier 2 support for technical or regulatory help desks, including issue triage, resolution, and escalation
Preferred Experience:
Experience supporting FDA or other federal regulatory agencies in electronic submission, data standards, or informatics modernization projects Familiarity with industry data standards such as CDISC, SEND, HL7, and experience with study data validation and profiling Experience with process improvement initiatives in a regulatory or scientific data environment. Experience developing and delivering training materials or user support documentation for regulatory systems Proficiency with tools such as Microsoft Excel, SharePoint, Outlook, and specialized FDA systems Project management or Agile methodology experience is a plus.
Education & Training:
Bachelor’s degree in a relevant field such as Business, Information Systems, Computer Science, Life Sciences, or a related discipline.
Salary Range:
$60,000-$80,000 Salary commensurate with experience.
Company Benefits:
DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).
EEO Commitment
DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and qualified applicants for employment without regard to race, color, creed, religion, national origin, gender, sexual orientation, age, gender identity, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local laws.
Reasonable accommodation for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing [email protected], or by dialing 571-482-2517.
DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).
Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at hr@drtstrategies.com if you believe you have received a fraudulent email. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Business Development and Sales Industries IT Services and IT Consulting Referrals increase your chances of interviewing at DRT Strategies by 2x Sign in to set job alerts for “Functional Analyst” roles.
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