- Collaborate with quality assurance group to prepare, compile, and publish regulatory submissions (e.g., pre‐IND/IDE packets, IND/IDE applications, BLA/NDA applications)- Devise regulatory strategies for clientele and communicate those strategies to regulatory agencies- Compiled research from scientific and medical papers to create quality, clinical, and nonclinical study summaries and reports - Assist regulatory/quality assurance to assure GLP, GMP, and GCP standards are maintained by vendors and clinical sites- Design, review, and edit regulatory documents such as protocols, Investigator’s Brochures, informed consent forms (ICFs), and case report forms (CRFs) in conjunction with quality assurance department- Audit regulatory documents from clinical sites for compliance to applicable national and international laws and/or guidelines including but not limited to FDA, EU, HC and ICH.- Collaborated with technical subject matter experts to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions including IND, NDA, and BLA- Strategized regulatory approach for investigators to garner support from FDA to proceed with clinical studies- Reviewed preclinical and clinical study data to evaluate client potential for the organization- Interviewed physicians and researchers to clarify mechanisms of action and contraindications in anticipation of questions from the FDA

- Facilitated process improvement and procedural standardization within the vivarium in coordination with Government client - Led and participated in new business development activities including promotion of company capabilities at professional events and conferences - Modified proposal submissions to be congruent with current company practices- Identified potential Research Funding Proposals- Reviewed and finalized technical and business proposals for typographical, formatting, formula, and content errors using Microsoft Office Suite and Adobe

- Directed and monitored organization staffing, including employee recruitment, selection, onboarding, training, career development, performance assessment, and disciplinary actions - Wrote and implemented Quality Management Plans for three HHS contracts including the National Institutes of Health (NIH) and the Environmental Protection Agency (EPA)- Evaluated animal care contracts for compliance with Quality Management Plans and contract deliverables- Engaged in pre-proposal strategic activities, proposal reviews, and proposal writing - Conceptualized and implemented Training Manuals and Quality Assurance Plans for four Department of Health and Human Services (HHS) contracts- Completed administrative management deliverables in the absence of the Vice President of Research including; invoice requests, monthly reports and, project status updates - Evaluated health care benefit packages for personnel to balance employee and company burden- Recommended revisions to the Employee Handbook to integrate updated company bylaws and benefits

- Generated Quality Management Plans for Government facilities in accordance with agency standards and Federal laws - Performed annual inspection of the contractual efforts for compliance to their respective Quality Management Plans- Regularly inspected preclinical research facilities for compliance with GLP, AAALAC, and IACUC, regulations, and guidelines