John Pierre Ruiz Email & Phone Number

Rockville, Maryland, United States

- Implements the strategic plan for the company, with particular focus on implementing new policy, procedures, and tools across the Operations Teams. - Established and heads the Enterprise Risk Management program, and manages compliance and regulatory affairs, working closely with legal and finance teams to ensure Dataprise meets all internal and external obligations.- Works collaboratively with our technology and innovation teams to ensure the department has the optimal technology, systems, and process to deliver a consistent and outstanding customer experience. -Leads the Compliance Department and all internal and external compliance efforts, to include regulatory compliance and compliance products offered to customers.-Creates auditing processes, establishes metrics, and is responsible for presenting Business intelligence reports for management, the executive team, and our board of directors. This role focuses on proactively partnering and engaging with the organization’s business and operations leaders to build and maintain an effective processes to service our customer base.

Rockville, Maryland

- Served as a trusted technology advisor responsible for defining winning strategies for multiple corporate and enterprise clients. - Analyzed the technical complexity of client environments and works to gain a deep understanding of how all aspects of the business interrelate to provide the appropriate roadmap to clients. - Researched various technologies and makes recommendations for the appropriate technologies/applications that can be implemented for a project or business goal/initiative. - Provided expert advice to clients on the technologies that can best support their business objectives to give them an edge over their competition. - Engaged in formal planning, requirements gathering, and budgeting for clients to manage business resources. - Developed and maintained business continuity, disaster recovery strategy, and operational plans. - Led risk planning and management strategies within client environments to help reduce overall risk and increase ROI of the present technologies. - Analyzed organization compliance requirements with laws and regulations (e.g., HIPAA, FISMA, PCI) and enacted strategies to close any existing gaps. - Developed and maintained service management and operation process frameworks for client delivery models. - Led budgeting and financial management activities, aligning budget advice to client business strategy and desired goals and outcomes. - Performed technology cost analysis in determining the true value of a technology investment (e.g., capital expenses, operating expenses), and outlined the return on investment and the total cost of ownership. - Facilitated all aspects of vendor selection/engagement and negotiation such as the request for information process, request for proposal (RFP) creation, price negotiation, vendor selection, contract management, and implementation management.

Silver Spring, Md

- Representative on strategic planning committees overseeing change and risk management and quality improvement initiatives throughout the Center. This involves the initiation, planning, execution, and control of new organizational entities in a massive reorganization of the Center.- Key Contributor on five initiatives: Center-wide patient preference strategic priority implementation, Center research metrics and communications, upper limb prosthesis research projects, computational modeling medical device development tools, and regulatory science metrics database development. Presented on these initiatives at conferences and the White House. Published multiple papers on these subjects.- Conducted research developing regulatory tools to assess product risk, safety and efficacy, medical device development tools, patient input into benefit-risk assessments and regulatory decision-making.- Managed Salesforce integration for the Center, replacing nearly 30 software tools with one custom made software framework, to include change management, risk management, CRM capabilities, and project tracking.- Improved Center research management and practice: Developed the strategy for metrics and risk management on Center research, protocols to enable public access to Center research outputs, methods for harmonization of research management between the three medical product Centers, and new tech transfer SOPs.- VP of Product Development for the aimHI program, a STEM outreach initiative that resulted in three mobile medical apps.

Cambridge, Ma

- Managed a team of four to model the development of an antisense oligonucleotide for seven disease states from inception through to NDA filing, and ultimately provide a priority disease and development strategy- Investigated the intellectual property and competitive landscape for each disease state, determined potential collaborators, and developed a market forecast, budget, and ROI strategy- Designed clinical trials, which included evaluations, endpoints, industry standards, and competitor design analysis, and presented a recommended regulatory pathway, approach, and timeline- Conducted weekly meetings and presentations with Sarepta and related groups, with benchmark reports given every month for a total of over 350 pages of analysis

Silver Spring, Md

- Developed an overall risk management program for the organization, to include framework, register, assessment, and compliance portfolios.- Incorporated a UK subsidiary, as well as outlined strategy for a JP subsidiary, to expand the organization’s presence abroad- Developed Salesforce as a system for collating and generating reports on finances and operations of the company, as well as tracking contacts, opportunities, leads, and sales initiatives- Assisted with reviewing and writing Orphan Designation Applications from clients such as Amgen and GT Biologics- Managed strategic partnerships with industry leaders and advised on strategic alliances globally - Instituted marketing initiatives by creating online promotional materials and enhancing visibility through social media- Represented the organization at conventions such as DIA and BIO, and handled logistics for over 30 additional conferences

Singapore

- Develop a marketing strategy for the introduction of a new Fragile-X diagnostic device into the US market- Developed a risk framework to include overseas regulatory and logistical risks to be accounted for in a Risk Register.- Interviewed key opinion leaders to develop a summary of unmet needs in physician labs- Created a pricing model based on both reference price and objective value of the device- Reported methods to address barriers of entry, such as adoptability and regulation (CLIA and FDA)

Claremont, Ca

- Managed a team of six, led the design phase of the project, created a product vision, and coordinated all meetings- Designed a device for the rapid, point-of-care diagnosis of neonatal sepsis, from the overall product architecture to the subsystem design and integration, including risk assessment, regulatory position, and clinical validation strategy- Summarized technical options for remote monitoring of neonatal sepsis into a comprehensive industry review- Produced CAD-assisted illustrations of our proposed device with proper dimensions and constraints

Gainesville, Fl

- Provided technical support to an entire college of faculty, staff, and students- Trained and managed a support team, including drafting management reports and customizing tools for CRM - Utilized troubleshooting skills to diagnose and resolve various computer-related issues- Assessed hardware and software for possible optimization and proposed new methods for enhancing the user experience- Facilitated large-scale IT projects by assisting domain admins with migrations and heavy patterning of data- Coordinated with users on a timely manner to meet their schedules and provide quality assistance- Demonstrated communication and judgment skills to alleviate pressure and stress caused by malfunctioning devices

Fifield Hall

- Tested viability of Phaseolus vulgaris and other plants as an alternative source of flavonoid synthesis for use in pharmaceuticals/Oncology research.- Analyzed DNA and RNA via multiple techniques including agarose gel electrophoresis, Sanger sequencing, blot analysis, and various bioinformatics strategies.- Extracted high quality, low contamination DNA and RNA samples.- Aligned sequences and analyzed using NCBI databases and BLAST functions.- Prepared degenerate primers for amplification of select sequences.- Assisted in error-checking new proprietary methodology in DNA purification.

Master Of Bioscience, Business Of Bioscience

Activities and Societies: Vice President of Student Government, PDA SoCal Student Chapter, Business of Bioscience Association, Biomedical.

Bachelor Of Science (B.S.), Plant Cellular And Molecular Biology, Biochemistry

Activities and Societies: Japanese Ambassador and Language Partner Program, Chinese American Student Association, Filipino Student.