The Role
Draft, review, and edit FDA compliance documentation (warning letters, import alerts, guidance, meeting materials). Collaborate with FDA program offices, legal counsel, and SMEs to ensure technical accuracy, regulatory alignment, confidentiality, and adherence to federal and FDA style requirements.
Summary Generated by Built In
Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, 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 Technical Writer will provide comprehensive writing and editing support for the FDA's Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Manufacturing Quality (OMQ).
Job Summary:
The Technical Writer will support OMQ's regulatory compliance and enforcement activities by drafting, reviewing, and editing a wide range of FDA compliance-related documentation. The Technical Writer will work collaboratively with FDA program offices, legal counsel, and subject matter experts to produce clear, accurate, and consistent communications that meet federal requirements and FDA style guidelines. This position requires strict adherence to confidentiality standards, as the role involves handling sensitive pre-decisional government information.
Responsibilities:
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, 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 Technical Writer will provide comprehensive writing and editing support for the FDA's Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Manufacturing Quality (OMQ).
Job Summary:
The Technical Writer will support OMQ's regulatory compliance and enforcement activities by drafting, reviewing, and editing a wide range of FDA compliance-related documentation. The Technical Writer will work collaboratively with FDA program offices, legal counsel, and subject matter experts to produce clear, accurate, and consistent communications that meet federal requirements and FDA style guidelines. This position requires strict adherence to confidentiality standards, as the role involves handling sensitive pre-decisional government information.
Responsibilities:
- Warning Letters: Draft, review, and edit warning letters issued to regulated entities for violations of FDA regulations, ensuring technical accuracy, regulatory citation precision, and adherence to FDA's warning letter format, tone, and enforcement policies.
- Import Alerts: Develop and edit import alert documentation for products subject to detention without physical examination, ensuring clarity in describing violations, affected products, and guidance for industry compliance, while maintaining consistency with Customs and Border Protection coordination requirements.
- Regulatory Discretion Documents: Draft policy statements and guidance documents outlining FDA's enforcement discretion positions, ensuring clear articulation of scope, conditions, and limitations, and verifying alignment with applicable statutory and regulatory frameworks.
- Regulatory Meeting Materials: Prepare briefing documents, meeting agendas, summary reports, and presentation materials for regulatory meetings with industry, advisory committees, and other stakeholders; edit meeting minutes and follow-up correspondence for accuracy and completeness.
- Performance Goal Analysis: Analyze and synthesize performance data related to FDA's annual reporting requirements and draft narrative sections explaining performance outcomes, trends, and contextual factors.
- External Stakeholder Talking Points: Develop concise, accurate talking points for FDA leadership and staff communications with external stakeholders, adapting technical content for diverse audiences including industry, consumer advocates, Congress, and media.
- A minimum of 5–8 years of professional experience in technical writing, preferably within federal contracts or the Department of Defense (DoD) environment.
- Demonstrated expertise in federal regulatory writing and FDA-specific documentation standards is strongly preferred.
- Proven ability to incorporate feedback from subject matter experts and legal reviewers efficiently and meet established deadlines while maintaining high quality standards.
- Experience handling sensitive or pre-decisional government information with strict confidentiality.
- Familiarity with a style guide (e.g., AP, AMA).
- Experience with the FDA, regulatory, healthcare, laboratory, pharmaceutical industry.
- Advanced proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.) and tools such as SharePoint and Adobe Acrobat.
- Experience with Visual Basic, EndNote, Adobe Acrobat.
- Familiarity with Section 508 compliance.
- A Bachelor's degree in one of the following fields: English, Journalism, Communications, Engineering, or a technical discipline (Engineering, Computer Science, Biological sciences).
- This position requires the ability to obtain and maintain a U.S. government Public Trust clearance. Due to contract requirements, candidates must be U.S. citizens or lawful permanent residents (green card holders) to be eligible.
- No agencies, third parties, or Corp-to-Corp submissions.
- $70,000 - $90,000
- Salary commensurate with experience.
Skills Required
- 5-8 years of professional technical writing experience
- Experience within federal contracts or Department of Defense environments
- Proven ability to incorporate feedback from subject matter experts and legal reviewers and meet deadlines while maintaining quality
- Experience handling sensitive or pre-decisional government information with strict confidentiality
- Familiarity with a style guide (e.g., AP, AMA)
- Demonstrated expertise in federal regulatory writing and FDA-specific documentation standards
- Experience with FDA, regulatory, healthcare, laboratory, or pharmaceutical industry
- Advanced proficiency in MS Office Suite (Word, Excel, PowerPoint), SharePoint, and Adobe Acrobat
- Experience with Visual Basic and EndNote
- Familiarity with Section 508 compliance
- Bachelor's degree in English, Journalism, Communications, Engineering, Computer Science, or Biological sciences
- Ability to obtain and maintain a U.S. government Public Trust clearance
- Must be a U.S. citizen or lawful permanent resident (green card holder)
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
DRT Strategies, Inc. (DRT) is an award-winning technology innovator and leading digital transformation partner to large federal agencies and commercial clients for nearly 20 years. The company is a ServiceNow™ Partner - Specialist, Amazon Web Services (AWS) Consulting Partner, UiPath Partner, SAFe Bronze Partner, Esri Bronze Partner, and holds ISO 9001:2015, ISO/IEC 20000-1:2018, and ISO/IEC 27001:2013 certifications and has achieved CMMI-DEV Level 3. DRT is headquartered in Arlington, Virginia, with offices in Atlanta, Georgia. More information on the company can be found at www.drtstrategies.com.
.png)
