Portugal
Over 12 years of experience in clinical research. Experienced in authoring regulatory and scientific documents, including clinical study reports, protocols, synopsis, protocol amendments, annual reassessment reports, and Module 2.5. Proven ability to manage 6–7 projects simultaneously, with strong experience in coordinating and delivering global and local studies. Backed by a medical background and recognized for producing clear, accurate, and compliant documentation that meets regulatory standards.
Reviewing and authoring post marketing documents (Module 2.5, addendum to clinical overview, Annual Reassessment report) and clinical documents (CSR, Protocol, Protocol amendment), project oversight, regulatory compliance, multiple project management, mentoring junior medical writers, quality assurance, working in collaboration with cross functional team. Assisting from medical writer department for IND, NDA, BLA submission and addressing health authority queries.
Reviewing and authoring regulatory (NIS, IS, PASS, HEOR studies) and clinical documents, project oversight, regulatory compliance, multiple project management, quality assurance, working in collaboration with cross functional team.
Authored and QCed Protocols (phase 1 to 3), Clinical Study Reports (phase 1 to 3), Informed Consent Document, and other Regulatory and Scientific documents in Haematology, Metabolic disorder, Pain management.
Authored Public Disclosure Synopsis for submission to EUDraCT, German regulatory authorities, and for Clients database