mike tortajada

* Interfaces with team members within Medical Affairs and DPC to complete audit project in an effective, constructive and timely manner. * Coordinates, oversees, and conducts internal audits to ensure compliance with audit plan and any applicable regulations, guidelines, and Standard Operating Procedures (SOPs). * Writes and reviews Audit Reports, and provides/implements recommendations for corrective and preventative actions as necessary; ensures training of internal staff as appropriate. * Writes and reviews SOPs and other procedural documents related to regulatory issues as needed. * Provides interpretation and consultation to team on regulations, guidelines, compliance status and policies and procedures.

* Managed the administrative, scientific, and budgetary operations of Global Investigator-Initiated Research (IIR) grants and collaborative agreements for multiple Pfizer products including Toviaz, Pristiq and Viagra. Developed periodic forecasts and year-end projections for grant projects. Coordinated monthly Grant Review Committee meetings. Acted as liaison with drug product teams, Contracts and Outsourcing, US project management and Medical Finance to fulfill grant-making requirements and facilitate payments. * Project Management * Regulatory Compliance * Quality Assurance * Global Operations * Study Monitoring * Lean Six Sigma Yellow Belt Certified * IIR System – INSPIIRE * Clinicopia * Ariba * Microsoft Office Suite * GDMS * Pegasus (PF Module)

* Assists in the daily activities of managing and coordinating the operational effort in the development and implementation of research-driven Investigator-Initiated Trials (IIT) * Work closely with Regional Medical Liaisons assigned to specific regional and therapeutic areas * Responsible for hands-on management and tracking of all aspects of the IITs and maintaining study data with the CTMS * Responsible for all study activation activities through completion of publication while ensuring regulatory integrity and SOP compliance * Maintains drug supply forecasting for all newly approved IITs. Work closely with IMSC to ensure forecasts are complete and accurate * Act as primary liaison to various cross-functional groups such as financing, contracting and drug supply in order to ensure study maintenance and compliance * Creates, maintains and audit studies in the Trial Master File throughout the duration of the study through completion as required per SOPs.

* Manages all day to day activities of large oncology program inclusive of Investigator-Initiated Trials (IIT), COOPs, and Third Party trials * Leads Medical Affairs Operations process improvement initiatives * Identifies, analyzes, and communicates problems, issues and opportunities. * Develops and implements effective solutions to achieve desired outcomes * Provides mentorship within functional team * Extensive knowledge of drug development process in the planning and management of clinical studies. * Responsible for all study activation activities through completion of publication while ensuring regulatory integrity and SOP compliance * Creates, maintains and audits studies in the Trial Master File throughout the duration of the study as required per SOPs

* Program management activities: Oncology Investigator-Initiated Studies (IIS), Pre-Clinical Collaborations, Sample Analysis Studies, Collaboration studies, Compassionate Use, Data Transparency, Ph4 Registries, RWE HEOR Studies, and Company Sponsored Ph4 Interventional Studies * Proposal Management: Ensures all proposals are complete, aligned with Areas of Interest, are reviewed by the governing body for specific study types, and all relevant decisions are obtained prior to moving approved studies forward. This may include agreement of activities from Product Team, Alliance Partner, Strategic Level alignment and Senior Management endorsement when appropriate; Applies to original proposals and amendments. * Meetings & Committees * Budget Management * Drug Supply * Metrics & Reporting * Contracting * Patent review/ Due Diligence Process * Vendor Management * Essential Documents Collection * Pharmacovigilance Compliance * Systems Management * Alliance Management