Laulima Government Solutions is looking for a Biodefense Regulated Laboratory Technical Writer on our United States Army Medical Research Institute of Infectious Diseases (USAMRIID) contract at Fort Detrick, Maryland.
This individual will write a variety of technical articles, reports, brochures, user guides, training materials, manuals, and other technical documentation for a wide range of uses by applying word processing, graphics and audio visual communications techniques for technical or scientific subject matter. Desires experience in a research setting with a variety of scientific and research concepts, practices, and procedures. For information technology writing, desires experience with planning, developing, maintaining, rewriting, and producing computer software/systems related documentation including tailoring style and readability to user requirements. Assists programmers and engineers with developing on-line documentation. Performs a variety of tasks including preparing complex report documents from raw and processed data and manipulating data and scientific findings into tables and text for presentation in a logical fashion.
Provide technical document writing and editing support to USAMRIID’s Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) capability. Knowledge and experience shall support performing the following specific tasks for 20 – 30 projects of varying scope per year.
Possess the scientific and regulatory background to work directly with Chief, NCD, Study Directors, principal investigators, nonclinical study teams, project managers, Quality Assurance personnel and GLP Archivist to manage preparation of complex reports and other documents from raw data and/ or processed data.
Process and tabulate data and observations into appropriate tables and text following standard templates, developing and establishing templates where needed.
Review and edit draft reports and other documents for organization, clarity, use of correct terminology and scientific standards.
Prepare documents to include but not be limited to nonclinical GLP protocols, SOPs, and associated documents; research reports; and nonclinical study reports that are in compliance with FDA regulations, e.g., 21 CFR 314, where the goal is inclusion in FDA animal rule submission.
Administer receipt, collation, and assembly of documents for review, to include management those processes; managing development and review of large documents with multiple review cycles and short deadlines.
Manage documents in electronic document management databases, and manage organization of retention of study documentation, including electronic raw data, in coordination with Institute GLP Archivist.
Participate in study and project meetings to provide input regarding deliverables, timelines, and processes.
Provide contract surge data technical writing/editing support in different areas throughout the period of performance of the task order.
Provide monthly progress reports in accordance with specific project timelines and deadlines.
BS Degree and 5 years’ experience
Required Skills and Experience:
5+ years of professional work experience as a technical writer in a relevant field (biomedical, medical, scientific)
Successful candidate must be proficient in editing technical documents
Proficient in the use of Microsoft Office suite of applications (Word, Excel, Outlook, PowerPoint, etc)
Must be detail oriented and take initiative
Experience with scientific database platforms (Oracle, Access, FileMaker, etc)
Working knowledge of Federal Regulations such as Good Laboratory Practices, Investigational New Drug (IND) application process, Animal Welfare Act, FDA Animal Rule, Electronic Records Management
Desired Skills and Experience:
Able to provide a technical writing sample
Experience working in Department of Defense and/or research environments
Must be able to obtain a National Agency Check with Inquiries with Law and Credit (NACLC).
Laulima Government Solutions. LLC is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid vacation and sick time; and 10 paid holidays. Laulima Government Solutions is proud to be an equal opportunity employer.
For additional information on Laulima Government Solutions, LLC, please visit www.laulimags.com.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status
Internal Number: 5072
About The Alaka'ina Foundation Family of Companies
The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms who are designated as Native Hawaiian Organization (NHO)-Owned and fall into the respective categories of Small Business (SB), 8(a) certified Small Disadvantaged Business (SDB), and HUBZone.
Certified in 2004 as a Native Hawaiian Organization (NHO), the Alaka`ina Foundation Family of Companies (FOCs) consists of Ke`aki Technologies, Laulima Government Solutions, K?pono Government Services, and K?pili Services. Our mix of capabilities, NHO procurement advantage, and contract vehicles present a strong tool set to the Federal acquisition community. These features create a total solutions package that is compelling and can support a variety of acquisition strategies. Through our total solutions, the FOCs has performed on a broad range of mission requirements. Each company represents the cohesion that we bring, as One Team with One Mission, to each and every project, program, and contract we undertake.
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