Senior Reg Ops Specialist SME

Overview:

LMI is seeking a Senior Reg Ops Specialist SME to support the Biomedical Advanced Research and Development Authority (BARDA). This position can likely be performed remotely. This position requires the ability to obtain a public trust clearance. You must be a U.S. citizen.

The Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, software, Assay chemistry, microbiology, virology, immunology.

LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.

LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!

• Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.
• Participate as subject matter experts on Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.
• Provide subject matter expertise for the management, design, publishing, review, submission, and archive of eCTD submissions, including amendments and original filing.
• Coordinate publishing and submitting of all electronic dossiers and documents to regulatory authorities and/or clients.
• Liaise with Regulatory Affairs Project Managers, and CROs directly, as necessary, to coordinate submission timelines and technical specifications and for client eCTD reviews.

• Recognized Regulatory Operations expert with a bachelor’s or equivalent degree
• Minimum of fifteen (15) years progressive experience in leading regulatory operational activities supporting drug, biologic, and device development regulated by the Food and Drug Administration (FDA)
• Expert knowledge of FDA submission types and management of FDA submissions compliant with the eCTD specifications
• Experience with electronic publishing software and advanced PDF processing tools
• Expert knowledge of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) content requirements for CTD dossiers
• Knowledge of and experience in document-level formatting and publishing
• Understanding of the eCTD structure as well as US publishing guidance’s and ICH specifications for electronic publishing
• Superior competency in MS Word
• Experience with Accenture Starting Point
• Preferred: Superior competency in Adobe Acrobat and ISIToolbox™ and/or other PDF toolset(s)
• Ability to build XML documents using Lorenz or similar publishing software
• Ability to self-train in areas that are not part of the routine processing for eCTD Submissions (i.e., CSR publishing, PEUA, EUAs)
• Ability to obtain a public trust clearance. You must be a U.S. citizen.