Technical Writer

Cape Fox subsidiary Eagle Health, LLC is seeking candidates for aTechnical Writerto support a government customer at Ft. Detrick.This position is contingent upon contract award.

Incumbents are encouraged to apply!

The salary range (or hiring range) for this exempt position has been established at:$105,000 - $119,000.

The above salary range represents the company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition, we offer a variety of benefits including company holidays, paid time off, health insurance, dental insurance, vision insurance, life and disability insurance, tuition reimbursement, as well as 401K with company match. This job will be posted until filled or withdrawn.

Job Summary

The Employee shall serve as an Institute resource to prepare complex report documents from raw and/or processed data and provide technical writing support to the USAMRIID Command and Public Affairs Office.

Essential Functions and Responsibilities

• Employee shall prepare documents to include but are not limited to: Protocols and protocols amendments, research and nonclinical study reports, and FDA animal rule submission documents in compliance with FDA/GLP regulations. Shall report data and scientific findings in appropriate table and text formats for presentation in logical fashion. Knowledge and experience shall support performing the following tasks for 10-15 projects of varying scope per year and shall support the review of 3-6 documents per month.
• Employee shall apply Subject Matter Expert (SME) level knowledge of MS Word.
• Employee shall create new or leverage existing templates to create new documents.
• Employee shall work with advanced styles within very large documents.
• Employee shall create, edit, and customize hierarchical lists, table of contents, list of tables, list of figures, and cross-references.
• Employee shall create, format and edit complex tables.
• Employee shall manage advanced Word options to allow troubleshooting with any aspect of Word documents, including styles issues.
• Employee shall process and tabulate data and observations into appropriate tables and databases and text following standard templates, developing and establishing templates where needed.
• Employee shall review and edit draft reports and other documents for organization, clarity, use of correct terminology and scientific standards.
• Employee shall prepare documents to include but not be limited to nonclinical GLP, SOPs, and associated documents; research reports; and nonclinical study reports that are in compliance with FDA regulations, e.g., 21 CFR Part 314, where the goal is inclusion in FDA animal rule submission.
• Employee shall print study documents for the study team as needed.
• Employee shall administer receipt, collation, and assembly of documents for review, to include management of those processes; managing development and review of large documents with multiple review cycles and short deadlines.
• Employee shall manage documents in electronic document management databases, and manage organization of retention of study documentation, including electronic raw data, in coordination with the institute's GLP Archivist.
• Employee shall attend and participate in study and project meetings to provide input regarding deliverables, timelines and processes as needed. Attend approximately 2-4 meetings per month.
• Employee shall execute work according to USAMRIID study team established project timelines; communicate effectively with peers, USAMRIID PM, management and internal customers regarding project status; monitor project status and proactively communicate to study team and TPOC potential delays and challenges.
• Employee shall foster positive working relationships with colleagues, study teams, QARCO, and other USAMRIID staff members.
• Employee shall respond to QR comments, QA findings, and CAPA Plans within the specified timeframe associated with the task; requested extensions must be justified.
• Employee shall maintain a current GLP training file describing applicable training and experience IAW USAMRIID SOPs.
• Employee shall complete written bi-monthly progress reports.
• Employee shall write, review and revise SOPs
• Employee shall read and understand all applicable protocols and amendments to support the generation of technical, interim, or final study reports.
• Employee shall perform quality control when reviewing study documentation during compilation of report template and contents.
• Employee shall maintain and update project time tracking in an electronic database.
• Employee shall assist the USAMRIID PAO with the review of technical documents and the writing, editing, and formatting of communications products as needed. Additionally, when PAO is out of office for extended periods, Employee shall support the USAMRIID Manuscript Review Process by serving as the PAO approver.