Plan and coordinate the preparation of regulatory submissions including meetings with health authorities, INDs, Annual Reports, and routine correspondence.
Plan and coordinate the preparation of regulatory submissions including meetings with health authorities, INDs, Annual Reports, and routine correspondence.
Establish and report on key performance indicators, including use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation.
Support clinical, manufacturing, and finance with medium and long term supply planning "what if" scenario analysis to support long term supply chain decision making.
Provide technical expertise and review clinical and non - clinical, regulatory, and quality aspects of advanced development and acquisition programs and proposals.
Work as part of an interdisciplinary team to assist BARDA contractors to develop valid, high - yielding and economical processes and analytical methods for the production of biopharmaceutical products.
Provide financial analysis on medical countermeasure products that have both commercial and bio defense indications, specifically identifying the sustainability / viability of a commercial market.
Works closely with the analytical development team and reviews analytical method, protocols, stability protocols and data, supports the API CMC development strategy for the small molecule development projects.
Ensure financial and technical risk, value and return analyses are robust and include realistic scientific understanding of R&D deliverables, costs and timings.
Monitor BARDA supported contractors' project timelines for key regulatory and quality performance measures, and provide recommendations to overcome challenges and reduce program risk.
Monitor BARDA supported contractors' project timelines for key regulatory and quality performance measures, and provide recommendations to overcome challenges and reduce program risk.
Contribute preclinical perspective to ongoing R&D product development: requirements, product and test designs, defect reviews, user workflows, and field complaint investigations.
Design and provide day-to-day operational oversight and support to drug safety and pharmacovigilance system, ensure compliance with national, regional, and global drug safety and risk management regulations and codes of conduct.
Provide subject matter expertise (SME) from Discovery through Phase 2 development for novel approaches using technology for early identification of infection.
Responsible for aspects of clinical trial including key data management activities in compliance with GCP's, SOPs and standards within established timelines, and budgets.
Work towards the strategic development of the HIL as a GCLP reference laboratory for HIV prevention research and other infectious diseases, prepare and review clinical data and scientific reports and manuscripts.
Collaborate with Supply Chain personnel to produce investigational product forecasts and identify distribution, storage, and accountability requirements.
Consult, provide technical expertise and thought partnership, to maximize the impact of projects and the creation of well - integrated vaccine clinical development plans, clinical study designs, statistical analysis plans, and clinical assays for vaccine clinical studies.
Support the configuration, administration and maintenance activities of the sites manufacturing computer and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historians.
