Technical Writer / Editor

Job Title: Technical Writer / Editor
Request ID: RFQ1826464
Project: CBER CASA-CV Support
Employment Status: Contingent upon contract award
Location: Washington, DC metropolitan area, including Rockville, Silver Spring, and Beltsville, Maryland
Work Arrangement: Local hybrid position. Remote work may be authorized by FDA, but the employee must be available for onsite meetings and activities when directed.
Schedule: Monday through Friday, generally 8:30 AM–5:00 PM Eastern Time
Travel: Local DC metropolitan travel may be required and is not separately reimbursable
Citizenship: Must be a United States citizen
Security Requirement: Must be able to obtain a Tier 2 Public Trust background determination and HSPD-12 PIV credential
Classified Clearance: Secret or Top Secret clearance is not required

Target Candidate Pay Rate: $47.22–$48.76 per hour

SMX Services & Consulting is seeking a Technical Writer / Editor to support documentation, reporting, meeting records, validation findings, procedures, and Section 508-compliant deliverables for the FDA CBER CASA-CV Support project.

The Technical Writer will work closely with project managers, bioinformatics analysts, clinical-data standards specialists, and FDA personnel to transform technical and scientific information into clear, accurate, well-organized documents.

• Prepare, edit, format, and quality-check technical and management deliverables.
• Develop meeting agendas, presentations, and meeting minutes.
• Capture and distribute meeting minutes for contractor and FDA meetings.
• Support preparation of weekly status reports.
• Support preparation of monthly status reports.
• Support monthly financial-report narratives and supporting documentation.
• Maintain consistent terminology, formatting, grammar, and document structure.
• Prepare and edit Pinnacle 21 Enterprise quality and findings reports.
• Translate technical validation findings into clear language suitable for FDA reviewers and stakeholders.
• Develop standard operating procedures, process descriptions, user guides, checklists, and training materials.
• Support the Project Management Plan and O&M Optimization Cost Reduction Plan.
• Edit risk registers, issue logs, action-item logs, schedules, and project documentation.
• Ensure documents conform to FDA-provided templates and standards.
• Coordinate document reviews, comments, revisions, approvals, and version control.
• Verify deliverables for completeness, accuracy, consistency, and traceability.
• Ensure final electronic documents comply with applicable Section 508 accessibility requirements.
• Remediate Word, Excel, PowerPoint, and PDF documents for accessibility.
• Support WCAG 2.0 Level A and AA requirements where applicable.
• Maintain documentation in FDA-authorized repositories such as SharePoint.
• Protect CUI, sensitive information, and non-public FDA information.
• Use only FDA-authorized equipment, email, VPN access, and document repositories.
• Meet recurring weekly, monthly, and rapid-response documentation deadlines.

• United States citizenship.
• Ability to obtain a Tier 2 Public Trust determination and FDA PIV credential.
• Approximately three to five years of relevant technical-writing, editing, documentation, or communications experience.
• Experience preparing technical reports, procedures, meeting minutes, presentations, or project-management documentation.
• Strong command of English grammar, spelling, punctuation, syntax, and document organization.
• Ability to understand and accurately communicate technical or scientific subject matter.
• Experience collaborating with technical subject-matter experts.
• Ability to manage multiple documents and recurring deadlines.
• Strong attention to detail.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat or comparable PDF tools.
• Ability to follow government templates, naming conventions, review processes, and version-control procedures.

• Experience supporting FDA, HHS, or another federal agency.
• Experience writing about clinical data, health information, scientific systems, bioinformatics, or regulatory processes.
• Familiarity with CDISC, SDTM, ADaM, SEND, or Pinnacle 21.
• Experience creating Section 508-compliant Word, Excel, PowerPoint, and PDF files.
• Familiarity with WCAG accessibility requirements.
• Experience working with SharePoint or another controlled document repository.
• Experience supporting government project-management and contract deliverables.
• Familiarity with CUI, federal records-management, and information-security requirements.

Send a current resume and compensation availability to: