Job Description

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Kelly Government Solutions offers scientists the opportunity to support basic and applied research projects designed to protect our military and nation from current and emerging biological threat agents. We are seeking a Research Documents Coordinator (Technical Writer) to support these efforts in a Department of Defense laboratory in Frederick, MD. ***Position contingent upon contract award.***

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Paid leave as well as 11 paid federal holidays and 401K plan.

- Professional development program for continuing job-related education/training

The Contractor Shall:

• Draft, edit, and format technical documents including protocols, protocol amendments, nonclinical study reports, FDA Animal Rule submissions, GLP reports, SOPs, and scientific publications.
• Collaborate with research scientists, study teams, regulatory affairs staff, and project managers across multiple concurrent projects (10–15 per year).
• Apply subject matter expertise in Microsoft Word, including creation and management of templates, hierarchical lists, tables, cross-references, and document troubleshooting.
• Participate in document review cycles and ensure final documents meet scientific, regulatory, and formatting standards.
• Process, tabulate, and format raw and processed data into standardized tables, charts, and scientific narratives.
• Manage document workflows, including collation, version control, electronic document management, and archival coordination with the GLP Archivist.
• Support quality assurance activities, respond to audit findings and CAPAs, and maintain GLP-compliant training and documentation records.
• Support internal and external study meetings (2–4/month), communicate project timelines, and track progress in centralized databases.
• Review and revise SOPs and contribute to continuous improvement of writing and compliance procedures.
• Assist the USAMRIID Public Affairs Office (PAO) with formatting and reviewing technical documents and communications materials, and act as the PAO approver during absences.

Qualification Requirements:

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biomedical Sciences, or related field). Advanced degree preferred.
• Minimum 5 years of experience in scientific writing or technical writing within a research, pharmaceutical, or regulatory environment.
• Strong working knowledge of FDA regulations (e.g., 21 CFR Part 314), GLP compliance, and document structures for FDA submissions.
• Demonstrated expertise with advanced Microsoft Word functions (styles, TOCs, tables, cross-referencing, template creation, etc.).
• Experience with electronic document management systems and familiarity with version control and document tracking practices.
• Excellent organizational, communication, and time management skills, with the ability to manage multiple projects with overlapping deadlines.
• Ability to work collaboratively with multidisciplinary teams and interface with scientific and administrative personnel.

PLEASE APPLY ONLINE

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

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