Qureos Mentor

DRT Strategies, Inc.

<div>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:<ul><li>
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.</li><li>
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.</li><li>
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.</li><li>
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.</li><li>
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.</li><li>
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.</li></ul>
Required Experience:<ul><li>
A minimum of 5&ndash;8 years of professional experience in technical writing, preferably within federal contracts or the Department of Defense (DoD) environment.</li><li>
Demonstrated expertise in federal regulatory writing and FDA-specific documentation standards is strongly preferred.</li><li>
Proven ability to incorporate feedback from subject matter experts and legal reviewers efficiently and meet established deadlines while maintaining high quality standards.</li><li>
Experience handling sensitive or pre-decisional government information with strict confidentiality.</li><li>
Familiarity with a style guide (e.g., AP, AMA).</li></ul>
Preferred Experience:<ul><li>
Experience with the FDA, regulatory, healthcare, laboratory, pharmaceutical industry.</li><li>
Advanced proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.) and tools such as SharePoint and Adobe Acrobat.</li><li>
Experience with Visual Basic, EndNote, Adobe Acrobat.
</li><li>Familiarity with Section 508 compliance.</li></ul>
Education &amp; Training:<ul><li>
A Bachelor's degree in one of the following fields: English, Journalism, Communications, Engineering, or a technical discipline (Engineering, Computer Science, Biological sciences).</li></ul>
Work Authorization, Clearance Requirement, &amp; Additional Information:<ul><li>
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.</li><li>
No agencies, third parties, or Corp-to-Corp submissions.</li></ul>
Salary Range:<ul><li>
$70,000 - $90,000</li><li>
Salary commensurate with experience.</li></ul>
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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Technical Writer - FDA

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DRT Strategies, Inc.

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Technical Writer - FDA