Employer Industry: Government Consulting and Biomedical Research

Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Work remotely with flexible hours
- Recognized as a #BestPlaceToWork in the United States
- Chance to contribute to critical public health initiatives and the development of medical countermeasures
- Supportive and people-centered company culture
- Competitive benefits package

What to Expect (Job Responsibilities):
- Support BARDA Program Offices as a subject matter expert on various threats, including chemical, radiological, and biological
- Advise on Technical Evaluation Panels, including reviewing technical proposals and budget proposals
- Provide expert assessments and guidance to Program Coordination Teams and federal staff
- Develop work products and reports related to BARDA’s mission and regulatory requirements
- Coordinate submission timelines and technical specifications with Regulatory Affairs Project Managers and CROs

What is Required (Qualifications):
- Bachelor’s degree or equivalent in a relevant field
- Minimum of fifteen (15) years of progressive experience in regulatory operations for drug, biologic, and device development
- Expert knowledge of FDA submission types and eCTD specifications
- Proficient in electronic publishing software and advanced PDF processing tools
- Ability to obtain a public trust clearance; U.S. citizenship required

How to Stand Out (Preferred Qualifications):
- Superior competency in Adobe Acrobat and ISIToolbox™ or other PDF toolsets
- Experience with Accenture Starting Point
- Ability to build XML documents using Lorenz or similar publishing software
- Self-training capability in non-routine eCTD submission processing areas

#GovernmentConsulting #BiomedicalResearch #RemoteWork #BestPlaceToWork #RegulatoryAffairs

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