RegOps Specialist SME

Job Description Background: The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks; pandemic influenza (PI), and emerging infectious diseases (EID). Together with its industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats. General SME Responsibilities: 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. 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; and plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic techniques, sterile manufacturing/filling and sterile facilities (sterile gowning) is also required. 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. Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work and make suggestions on ways to improve those statements of work. Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations. 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. Responsibilities specific to RegOps: 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. 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. Qualifications: Recognized Regulatory Operations expert with a bachelor’s or equivalent degree. At least ten (10) 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 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. Additional Information: BryceTech offers a full range of benefits, including competitive salary, a comprehensive health plan including dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, and an educational reimbursement program. All your information will be kept confidential according to EEO guidelines.

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