Technical Writer - FDA

DRT Strategies, Inc.•Silver Spring, MD

3d•$70,000 - $90,000

About The Position

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. 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). 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.

Requirements

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).

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
Analyze and synthesize performance data related to FDA's annual reporting requirements and draft narrative sections explaining performance outcomes, trends, and contextual factors.
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.