Maria Joao Santos

Medical writing in different therapeutic areas - Co-development and revision of Protocols and Case Report Forms for effectiveness safety surveillance risk management utilization patterns and cost-effectiveness studies development and revision of Patient Information and Informed Consent Forms.Management of regulatory authority applications and approvals - Submission to National Data Protection Competent Authority Ethic Committees Regional Health Administrations and Hospitals' Administration Boards for implementation of late-phase studies.Good communication and liaison (national and international) - Contact with Investigators and other study personnel Pharmaceutical Industry Patients Health Associations partner Contract Research Organizations located in different countries. Project management - Management of national and international project operations definition of study timelines and milestones meetings and teleconferences leader presentation of project status creation of progress reports and newsletters development of strategies identification of problems/difficulties and suggestion of potential solutions budget control quality control and involvement in Standard Operating Procedures (SOPs) writing. Coordination and supervision - Ensure under direct line management responsibility that staff metrics and objectives are clear and achieved. Assessment of metrics according with Business Unit and Company objectives. Ensure that staff complies with regulations