Ordered and tracked required documents to ensure timely submission for processing/underwriting review and loan approval in accordance with all agency, state and federal guidelines. Liaison between loan originators, loan processor, underwriters, closers, escrow agents, insurance agents, employers and appraisal management companies. Trained colleagues and new employees in various aspects of document ordering and tracking as well as proficient use of Encompass and Outlook software.

Provided clerical assistance to multiple senior partners using internal software programs and Microsoft Office. Developed and maintained legal document files. Reviewed and processed expense reports to ensure accuracy before submitting to corporate headquarters. Reviewed and processed billing statements to ensure accuracy prior to mailing to clients.

Assisted the President of LED Medical Diagnostics by providing direction and structure for operating units to ensure attainment of business plan growth and profit. Participated in developing policy and strategic plans consistent with established goals, objectives and policies set by the CEO and Board of Directors. Used prior clinical and regulatory experience to provide strategic expertise for future diagnostic product development.

Clinical and Regulatory Submissions Management Consultant services for development-stage Biotechnology Company. Provided strategic expertise for pre-IND and IND filings with potential applications such as radiation exposure, infectious disease and wound healing through stimulation of human adult stem cells.

Managed Clinical Research Organizations, Investigational Research Sites, consultants and vendors for multiple Phase III, Global Multi-center studies related to oral cancer detection. Performed daily in-house operations associated with the studies. Maintained compliance of clinical studies per federal regulations, GCP and ICH guidelines. Achieved the fastest and most effective contractual negotiation with a global CRO over a 17 year span. Participated in the design of key study documents such as protocol, CRF,eCRF, Informed Consent, statistical analysis and data management schematics. Exceeded normal timelines based on fast and accurate budget development and review, quick negotiation process, strong decision making ability, comprehensive review of clinical and regulatory documentation and effective team coordination. Coordinated and attended Investigator Meetings and quarterly Medical Advisory Board meetings. Effectively performed various aspects of project management. Ensured adherence to budget and timelines for all studies as well as adherence to corporate insurance and legal standards.Attended End of Phase II meeting, pre-NDA meeting and Oncology Drug Advisory Committee (ODAC) meeting. Planned all meeting activities between corporate sponsor representatives, principal investigators, regulatory attorneys and key public speakers for ODAC meeting. Recorded and filed official corporate meeting minutes in accordance with FDA regulations.Provided clinical update for European and U.S. regulatory filings. Filed responses to Agency requests during review of NDA. Participated as the clinical technical representative during FDA Site Inspection.

Supported portfolio development activities and search for potential corporate partners by providing input during strategy development. Validated business models for partnerships, acquisitions or third-party subsidiary rights. Participated in deal negotiations, contract development, and due diligence. Conducted public information and internet searches to identify potential business partners. Led market research for products in various stages of development or commercialization. Organized data for third-party vendors and Corporate Board of Directors.Built partnerships and business relationships via attendance of major dental trade shows.Provided corporate management with legal and regulatory support for products in various stages of development or commercialization.Acted as primary interface with corporate patent attorney and managers regarding corporate patent and trademark records; improved processes and policies for maintenance of applications, renewals and new patents. Approved and successfully maintained budgets. Contributed to team development and implementation of new product launches. Managed marketing, advertising, media review and special sales plan activities during new product launch. Ensured eight new product launches were on time and within budget.

Developed and maintained corporate legal, regulatory, clinical, technical and marketing files.Liaison between attorneys, clinical research organization, clinical research sites, analytical labs, regulatory agencies and professional medical/scientific consultants during NDA filing period.Interfaced with third party legal consultants regarding regulatory, patent/contract issues and.Assisted with formulation of new international corporate entities and provided support to VP/GM Zila Europe and Zila China for contract, marketing/advertising, sales leads and regulatory issues.Provided operational support to third party manufacturers regarding packaging/labeling issues.Maintained and tracked all international marketing, distribution, manufacturing, and sales records. Collaborated with international customers, prospective domestic customers and academic institutions.