Technical Writer FDA

• 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 FDAs 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 FDAs 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 FDAs 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 58 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 Bachelors 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.

• $70000 - $90000
• Salary commensurate with experience.

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.

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