DRT Strategies
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:
This role is only 50% (half-time for a full-year, or 940 hours). The Help Desk Analyst provides Tier-1 support for electronic submission and data standards systems, working under the guidance of a senior help desk lead. This role is responsible for responding to user inquiries, documenting and triaging issues, and ensuring timely resolution or escalation of tickets related to FDA submission platforms. The analyst applies analytic methodologies to evaluate project objectives, supports data collection and performance measurement activities, and contributes to process improvements. Duties include collaborating with project teams, assisting with data modeling and project testing, and maintaining accurate records to support operational and strategic goals. The Help Desk Analyst works closely with senior analysts and project managers to ensure high-quality customer service and effective support for both internal and external stakeholders.
Responsibilities:
Provide Tier-1 help desk support for electronic submission and data standards systems, including responding to user inquiries via dedicated mailboxes during business hours
Identify, document, classify, triage, and resolve or escalate all user tickets/issues related to FDA electronic submissions, ensuring timely and accurate handling
Support users (industry sponsors and internal stakeholders) with technical and general questions about FDA submission tools, standards, and system processes
Participate in the review, validation, and testing of new and updated electronic submission tools, and document tool deficiencies or gaps
Assist with operational tasks such as managing sample application numbers, supporting sponsor meeting package reviews, and maintaining knowledge base documents (FAQs, SOPs)
Facilitate and support user training logistics, including class scheduling, registration tracking, updating training materials, and providing training support for new or updated systems
Collaborate with project teams, technical staff, and subject matter experts to resolve complex issues and ensure continuous process improvement
Maintain accurate records, metrics, and documentation to support reporting, process improvement, and quality assurance activities
Provide customer support for all methods of electronic submission receipt
Escalate unresolved technical issues or complex inquiries to Tier-2 support or appropriate FDA business units within defined timelines
Require Experience:
At least 5 years of technical expertise providing Tier 1 and Tier 2 help desk support, including identifying, documenting, triaging, resolving, and escalating user inquiries related to electronic submissions and data standards
Demonstrated experience supporting FDA electronic submission data standards and processes
Experience developing, updating, and delivering comprehensive training programs and materials for diverse stakeholder groups.
Proven ability to manage high-volume email/mailbox support operations, including issue resolution and escalation processes
Ability to use Microsoft Office Suite (Excel, Outlook, SharePoint) with minimal guidance
Strong written and verbal communication skills for responding to user inquiries, documenting SOPs, FAQs, and knowledge base articles
Experience working in an environment with strict adherence to SOPs, privacy, and security requirements
Preferred Experience:
Prior experience supporting large-scale electronic submission programs for FDA or similar regulatory agencies
Familiarity with FDA’s CDER Informatics Platform, Electronic Submission Gateway (ESG), NextGen Portal, and related systems
Demonstrated ability to meet or exceed service level agreements (SLAs) and deliver high-quality work products with minimal oversight
Experience coordinating technical support across multiple help desk operations and collaborating with subject matter experts
Experience with process improvement initiatives to increase efficiency and reduce manual hours in help desk operations
Knowledge of FDA operational policies, data validation requirements, and modernization projects
Education & Training:
BS/BA degree
ITIL Foundation Certification preferred
Salary Range:
$60,000-80,000 or $28-38 per hour
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 HR@drtstrategies.com, 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.
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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.
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:
This role is only 50% (half-time for a full-year, or 940 hours). The Help Desk Analyst provides Tier-1 support for electronic submission and data standards systems, working under the guidance of a senior help desk lead. This role is responsible for responding to user inquiries, documenting and triaging issues, and ensuring timely resolution or escalation of tickets related to FDA submission platforms. The analyst applies analytic methodologies to evaluate project objectives, supports data collection and performance measurement activities, and contributes to process improvements. Duties include collaborating with project teams, assisting with data modeling and project testing, and maintaining accurate records to support operational and strategic goals. The Help Desk Analyst works closely with senior analysts and project managers to ensure high-quality customer service and effective support for both internal and external stakeholders.
Responsibilities:
Provide Tier-1 help desk support for electronic submission and data standards systems, including responding to user inquiries via dedicated mailboxes during business hours
Identify, document, classify, triage, and resolve or escalate all user tickets/issues related to FDA electronic submissions, ensuring timely and accurate handling
Support users (industry sponsors and internal stakeholders) with technical and general questions about FDA submission tools, standards, and system processes
Participate in the review, validation, and testing of new and updated electronic submission tools, and document tool deficiencies or gaps
Assist with operational tasks such as managing sample application numbers, supporting sponsor meeting package reviews, and maintaining knowledge base documents (FAQs, SOPs)
Facilitate and support user training logistics, including class scheduling, registration tracking, updating training materials, and providing training support for new or updated systems
Collaborate with project teams, technical staff, and subject matter experts to resolve complex issues and ensure continuous process improvement
Maintain accurate records, metrics, and documentation to support reporting, process improvement, and quality assurance activities
Provide customer support for all methods of electronic submission receipt
Escalate unresolved technical issues or complex inquiries to Tier-2 support or appropriate FDA business units within defined timelines
Require Experience:
At least 5 years of technical expertise providing Tier 1 and Tier 2 help desk support, including identifying, documenting, triaging, resolving, and escalating user inquiries related to electronic submissions and data standards
Demonstrated experience supporting FDA electronic submission data standards and processes
Experience developing, updating, and delivering comprehensive training programs and materials for diverse stakeholder groups.
Proven ability to manage high-volume email/mailbox support operations, including issue resolution and escalation processes
Ability to use Microsoft Office Suite (Excel, Outlook, SharePoint) with minimal guidance
Strong written and verbal communication skills for responding to user inquiries, documenting SOPs, FAQs, and knowledge base articles
Experience working in an environment with strict adherence to SOPs, privacy, and security requirements
Preferred Experience:
Prior experience supporting large-scale electronic submission programs for FDA or similar regulatory agencies
Familiarity with FDA’s CDER Informatics Platform, Electronic Submission Gateway (ESG), NextGen Portal, and related systems
Demonstrated ability to meet or exceed service level agreements (SLAs) and deliver high-quality work products with minimal oversight
Experience coordinating technical support across multiple help desk operations and collaborating with subject matter experts
Experience with process improvement initiatives to increase efficiency and reduce manual hours in help desk operations
Knowledge of FDA operational policies, data validation requirements, and modernization projects
Education & Training:
BS/BA degree
ITIL Foundation Certification preferred
Salary Range:
$60,000-80,000 or $28-38 per hour
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 HR@drtstrategies.com, 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.
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