Monica C. Mora Email & Phone Number

Miami, Florida, Us

• Regulatory Affairs: Developed internal local regulatory strategies, processes, & procedures to optimize the fast approval by INVIMA of clinical trials, & product registration, in accordance with global practices. Led regulatory interactions with local operating companies in the region to ensure regulatory compliance.• Project Management: Managed projects & field operation groups including training, development & growth initiatives. Developed strategic direction, global integration, & expansion of clinical operations for the company. Collaborated with internal teams to work with Colombia's government agencies & industry associations to draft proposed changes to Colombia's research environment to make it more attractive to foreign trial sponsors.• Business Development: Facilitated strategic & business alliances both in the U.S. & internationally. Strategically developed and maintained high-level client sponsorships & partnerships. Managed & built corporate relationships. Expanded new corporate partnerships. Managed persuasive proposals. Identified & framed opportunities.• Global Clinical Operations: Led first-in-man phase clinical trials internationally. Worked collaboratively with other development operations teams to agree on processes, systems, and procedures to conduct global development operations. Managed local legal operations including coordination, negotiation, & successful resolution of conflicts with local sites’ administrative staff, their legal counsels to enable timely execution of NDAs, CTAs, work orders & budgets. Directed & led operations for multiple global clinical programs.• Study Management: Ensured team operations, locally & globally as appropriate. Ensured timely communication & problem resolution occurs when study progress may not be meeting study goals. Ensured proper study global tracking & management. Planned study prioritization, budgetary requirements & goal attainment. Ensured consistency with processes & procedures

The LATAM Medtech Leaders Podcast is supported by Med Device Online and is a weekly conversation with leaders who have succeeded in Latin America. Visit the podcast page at https://www.bioaccessla.com/podcast. Foreign Medtech companies struggle to find a cost-effective clinical trial site or to gain market share in Latin America. LATAM Medtech Leaders delivers insightful interviews with leaders of medical technology companies with meaningful experience conducting first-in-human trials or with the commercialization of their medical devices in Latin America. They talk about their experiences in the region and provide a pathway for other leaders to follow so that they can save time and avoid costly mistakes.

• Legal Operations: Broad responsibilities that encompassed the timely and complex preparation of cases from discovery to hearing phase. Drafted documents and agreements ensuring business terms and structure were fulfilled. Quickly identified advantages and risks involved in each instance.• In-Depth Research: Applied analytical background to conduct extensive and conclusive legal research using online resources and customized models, to provide case-relevant data and materials. Performed background searches, cross-referenced information from different agencies. • Case Management: Completed all aspects of case applications, including review, submission, filing, and closing process. Ensured timeliness, completeness and accuracy of each application. Determined next action required. Coordinated multifaceted office functions encompassing allocation of human resources to different cases. Ensured internal communication. Understood workflows used by the firm and, when necessary, suggested changes in workflows that resulted in increased efficiency• Client Relations: Maintained ongoing communication with attorneys, clients, and government agencies from the point of referral/discovery to court phase, facilitating and expediting case processing.

• Business Development: Oversaw account retention and new-market penetration. Elaborated complex proposals. Provided effective responses to request for proposals (RFPs). • Analysis: Used sensitivity analysis to determine best profit margin, merits, and risks for each business prospect. Performed company and market research, and built key strategic relationships. Built and managed client portfolio using customized mathematical marketing models.• Project Management: Managed projects, including preparation of legal materials while ensuring regulatory compliances on solutions. Handled all steps for contract execution and closing. Developed, implemented and trained other areas in complex, Excel-based financial business models. • Client Relations: Responsible for consulting, advising, and delivering demonstrations to new and existing customers; praised by management and customers for critical abilities while gathering client information, analyzing data, and providing appropriate recommendations.

• Analysis: Produced mathematical models to evaluate company portfolio and acquisitions using different technology to originate relevant data. Performed Real Estate business valuations based on Sales comparison and income producing approaches. Analyzed companies financial needs to raise capital. • Operations. Executed on-site real estate property inspections, evaluated neighborhoods values, and observed external factors potentially affecting property values. Assisted clients with diverse proceedings, including but not limited to property analysis encircling property, market and industry analysis. Conducted computerized and law library research• Business Development: Served as the driving force behind start-up and growth of private investment company, building a $3.2 million portfolio in less than four years. Developed business plans, mid-term strategic plans and short-term financial plans in response to industry and economic challenges. • Financial Management: Spearheaded all internal operations, including negotiation of diverse agreements. Elaborated “what-if” analysis to examine changes in real estate property values and customers’ affordability situations. Coordinated approvals and documents required to finalizing real estate transactions. Oversaw the deal approval process. Ensured timely submission of statutory filings.• Client Relations: Provided managerial oversight to large, diverse, complex client engagement. Created and delivered presentations to investors. Planned and provided informative seminars to educate and create awareness.

Espoo, Southern Finland, Fi

Lucent is now part of Nokia. The company focused on fixed, mobile and converged networking hardware, IP technologies, software, services, and has operations in more than 130 countries.Provided high-level training efforts for Lucent Technologies. Developed, designed and presented multilevel technical courses in a corporate or academic environment, including classroom sessions, train-the-trainer, video conferencing, web-based training, CBT, and Q&A to employees, customers and end-users with varying levels of knowledge, skills, abilities and needs.

Responsible for direction of the largest unattended territory within the company. • Increased branch revenue by more than 50%. • Improved operational effectiveness of branch, actively engaging other company resources as necessary.• Designed and implemented strategic and financial plan. • Prepared budget and presented it to headquarters for approval. • Performed competitive analysis, through benchmarking and performance monitoring (Analyzed market share and data on competitors).

Conducted college-level courses in Computer Science studies to “Universidad Autonoma del Caribe” and served as academic advisor for students.

• Increased gross profits margins by restructuring organization through value-added analysis.• Played key role in increasing sales by 18% in a 3-year timeframe through business analytics.• Provided ad-hoc operational and financial analysis to upper management.• Developed sensitive analysis to support critical business decisions and applied mathematical methods to build excels models to compare and adjust financial plans.• Precursor to development and implementation of strategic plan.

Instructed classes in Software Project Planning, Data Structures, Turbo Pascal programming, and Computer Algorithms. Planned lectures, administered examinations, and assisted students outside the classroom.

• Assisted in the preparation and development of present and future financial performance reports. • Participated in development of financial mathematical models to support the different analysis performed by each business unit within the organization.

Graduate Certificate In Business Management, Business

Small And Medium Business Management Graduate Certificate, Business

Minor In Engineering Project Management, Management

Bachelor’S Degree, Computer Science, Engineering