Moises Gutierrez Email & Phone Number

Accountable for all Managed Access Programs for the Cluster MC3 (Mexico, Central America & Caribbean) in Oncology for all operational aspects. ensuring high quality of the end-to-end process. Proven expertise in the simplicity process ensuring the successful of the implementation and execution project with adequate and available resources in the organization. Challenging the process and ensuring implementation of standards and process in the organization in alignment with relevant laws and regulations.Role model for other countries, sharing the local best practices with global and regional team-members leads, ensuring optimal prioritization of operational activities for programs in line with the strategic plans in the company.Managed Access Programs culture as awareness for the internal & external people involved in the programs.Savings provided for the logistics operation during 2019. W&D expenses decreased to 70%Responsible for acting as a single point of contact for the global and regional team to provide a local or franchise input, reporting the project progress and issues with their resolutions. A good exposure developed to lead in the different interaction with all relevant functions.Actively participate as cross functional & cross divisional panel membership in initiatives assigned by local and regional teams.A good enough ability to lead a multidisciplinary team in a complex matrix environment as well as ability to build effective relationship with stakeholders based in the engagement. Responsible for managing the on-boarding of operational team, training- coaching and mentoring of new staff. Responsible for attending the inspections and audits ensuring the correct management of programs, such as all the information in databases and tracking systems, attending all the physician request and ensuring all deliverables according timelines, budget, quality standards, SOP and business guidance.

As BPA, I had the experience of being a strategyc-business partner for the Medical Advisors, providing support and full-administration for medical finances, allocating the resources in the best way to maximize the brands through adjustments and changes in the LO (Latest outlook) by brand and Non-promo Event.Key financial activities such as creation of budget detailed by internal orders, cost elements and cost centers. Analysis of expenses by functional area (vs LO, LF1, LF2 and Budget) Execution of many useful financial systems and tools: FCRS, Business Planning Control (Platform), cross charge, accruals, reclassifications, reimbursements (Intercompany invoices)Reporting (Dashboard) and Follow-up with vendors, payments, invoices, conciliations, etc. Forecast & Demand for the local Drug- Supply, CUPs (Compassionate Use Programs)Planning & Trial Management.- Creation of Trial budget, submissions, assumptions, reconciliation and close out of TCF (Trial Commitment Form).Point of contact with the Regional BPA (TCs monthly) to report the Trial expenses, monthly briefing, conciliations, actuals, etc.Inspections-_Matrix BPC (Audit Ready Inspections)

In this project, I was responsible in the full management for the financial-service contracts for all oncology clinical trials, achieving a good enough negotiation with the principal Investigators, staff, labs and other vendors related to the clinical research development.Internal & external follow-up with people accountable for the contracts (IMSS). Target visits to the potential sites and Institutions executed to evaluate our opportunities areas and improve them (INCAN, CANIFARMA, etc.). Creation and administration of local Fair Market Value, according to the local rate and budget by protocol.Key figure in the Lean Project (Six Sigma) applied to the financial-service contracts, besides to providing financial support for the payments to the Investigators and Sites.

Proven expertise as CTA (Clinical Trial Associate) based on the regulatory reports, statistics and global metrics, besides to the management of database for the medical information-protocols.Being the Start-up the key phase for the beginning of any Clinical Trials, the participation at AMIFF program to improve the start-up at Country-Pharmaceutical level was important for the UHAPs creation and the Initial Contracts was the trigger to this initiative.

Start-up process. Active submissions to the Committee and MoH (Ministry of Health), including regulatory information, translations, etc.Proven expertise as SME (Subject Matter Expert) of TMF (Trial Master File) system. Generation of smart reports and statistics from TMF system.Sr. at Quality Control of all clinical trial documentation uploaded at the TMF system. Coaching & mentoring model for the Monitors-clinical research associates. Co-Monitoring visits to support in the quality and archiving of site-Investigators file.

Control to the depot operation for the investigational medicine product, including all the life-cycle of the product process such as shipments, inventory, destruction, maintenance, etc.Strong and professional skilled in the planning and logistics activities to get the control of clinical investigational product. Administration in electronic files before, during and after clinical trial conduction.Implementation of Local SOPs

Diplomado, Finanzas

Diplomado, Clinical Trial Monitoring

Industrial Engineering