Operations Specialist

Reg Ops Specialist SME | Healthcare and Life SciencesProSidian Seeks a Reg Ops Specialist SME | Healthcare and Life Sciences - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Executive Consultant/SME I Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA's mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases.Seeking Reg Ops Specialist SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This as a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Reg Ops Specialist SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World). RESPONSIBILITIES AND DUTIES - Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014] 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.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. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.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 neededProvide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed workReview 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.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.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.QualificationsDesired Qualifications For Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014] (HHS109014) Candidates:Bachelor's degree or equivalent qualification.At least 10 years of experience in leading regulatory operations supporting drug, biologic, and device development regulated by the FDA.Expertise in FDA submission types and eCTD specifications.Knowledge of ICH guidelines for CTD dossiers and electronic publishing. Education / Experience Requirements / Qualifications Bachelor's degree or equivalent qualification in a relevant field.Additional certifications or training in regulatory operations and publishing software preferred. Skills Required Superior competency in MS Word, Adobe Acrobat, and PDF toolsets (e.g., ISI Toolbox™).Experience with electronic publishing software (e.g., Lorenz or similar tools) and XML document creation.Advanced knowledge of FDA and ICH submission requirements.Ability to self-train in specialized areas (e.g., CSR publishing, PEUA, EUA). Competencies Required Strong project management skills for submission coordination and timeline management.Ability to design, review, and archive eCTD submissions, including original filings and amendments.Knowledge of FDA regulatory frameworks, guidelines, and operational requirements.Exceptional attention to detail in formatting, publishing, and dossier preparation. Ancillary Details Of The Roles Provide subject matter expertise for managing and submitting electronic dossiers to regulatory authorities and clients.Liaise with regulatory affairs project managers and CROs to coordinate submission timelines and technical specifications.Expertise in compliance with US publishing guidance and ICH specifications for electronic submissions.Deliverables include properly formatted and compliant eCTD submissions, CSR publishing, and EUA filings.Support BARDA Program Divisions by aligning with regulatory and operational requirements.Provide training and guidance on publishing tools and FDA submission requirements Other Details Knowledge of Accenture Starting Point preferred.Ability to provide strategic advice on submission planning and regulatory publishing improvements.Advanced skills in risk analysis and benefit assessment for submission success.Engagement in BARDA's mission to enhance regulatory readiness for medical countermeasure development.Additional Information CORE COMPETENCIES Teamwork – ability to foster teamwork collaboratively as a participant, and effectively as a team leader Leadership – ability to guide and lead colleagues on projects and initiatives Business Acumen – understanding and insight into how organizations perform, including business processes, data, systems, and people Communication – ability to effectively