Senior Medical Advisor and Writer Madrid, Spain
Since January 2006
I have a 10-year experience as a medical advisor and writer (freelance) for pharmaceutical, medical devices, food, communication and publisher companies (from Spain, France, UK, Denmark, Germany, and US), and 20-year experience as a professor and investigator in different universities and research centres (from US, UK and Spain).
I am currently working home-based in Madrid (Spain), performing very varied (clinical research, regulatory, marketing, communication and education) medical-related tasks for national and international companies; directed to various audiences (medical specialists, students, pharmacists, patients, sales personnel, nurses).
The medical information of my documents are in accordance with the updated scientific evidence in the different fields, and with the pertinent clinical guidelines and regulatory and ethical requirements.
Even that my academic degree is doctor in veterinary medicine, I have been working with physicians (of different human specialties), starting from preclinical research (like my PhD or my 3-year stay in the UK, both performed in the experimental units of human university hospitals) and the last 10 years of my career have been devoted to clinical research and medical affairs. My relationship with physicians, including international key opinion leaders, are EXCELLENT and fruitful.
The fields of my works corresponded to a wide variety of pathologies and therapeutic areas, like diabetes, Alzheimer’s disease, oncology, biological medicines, analgesia/pain, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), psychiatry, psychology, multiple sclerosis, asthma/allergic rhinitis, cardiology, arterial hypertension, dermatology (atopic dermatitis, acne, psoriasis, etc.), dyslipidaemia, osteoporosis, gastrointestinal disorders, nutrition, endocrinology, neuroscience, tissue engineering for clinical implantations, imaging diagnosis, physiotherapy, therapeutic electro-medical equipments, ophthalmology, hepatitis, acromegaly, etc.
Nowadays my priority is to find a full-time permanent job but, meanwhile, remaining available for new freelance works.
I would like to remain working remotely from Spain, home-based; but, if I would have to move, my first preference would be the UK, followed by any European country. Moreover, I am available for national and international travels.
My native lenguage is Spanish and I have a professional level in English, both in lay or scientific terms. I have lived and worked in English speaking countries for six years (the United States and the United Kingdom, three years on each of them). I am writing in English most of my current works; and all the sicentific literature that I read is in English. Furthermore, I have lectured to students of very different educational levels both in English (University of Califonia and University of Bristol) and in Spanish (Complutense University and University of Léon).
I don’t have any formal certificate as a translator or for translation services, but I have a 10-year experience as a medical advisor and writer using two languages, English and Spanish in a number of documents targeted to experts of many medical specialties and also preparing documents for the health regulatory Authorities, following international and European standards (pertinent legal requirements, International Committee of Harmonisation, Good Clinical Practices, ethical principles, etc.). I write most of my documents in English, some of them in Spanish, and I also have experience in translations from English into Spanish and vice versa. I have translated many protocols of clinical studies (later approved by the corresponding health Authority), some clinical guidelines, a whole book, and several documents for international professional organisations.
By association with other medical translators, I can provide translations that comply with the current international standard ISO 17100:2015 for translation services.
Profesor and investigator From Spain, US and UK
September 1986 --- December 2005
Teaching and research in various biomedical fields.
AdaptabilityAnalytical thinkingAssertivenessAttention to detailAuthenticityCollaborationCommunicativeCompetitivenessCreative thinkingCritical thinkingCuriosityCoordinationEfficiencyFlexibilityInnovative thinkingInterest in knowledgeOptimismProactivityProblem solvingResponsibilitySelf-confidenceSociabilityService orientedWillingness to compromiseDiligenceIndependenceOrganizationSelf-discipline
Animal models Biochemistry Cell biology Diabetes Medical devices Phase I R&D Scientific writingAllergy and immunologyAngiogenesisAntibodiesBiomedical SciencesBiopharmaceuticalsCancerCancer ResearchCardiovascular diseasesClinical pharmacologyClinical researchClinical Study DesignClinical operationsClinical study reportsClinical trial designClinical trial managementClinical trialsCNSCRFCRF designCRODermatologyDesigning case report formsDeveloping Clinical Trial ProtocolsDiabetesDiagnostic radiologyDiagnosticseCRFeCTDEarly development stageEfficacy trialsGeneral MedicineGeneral practiceGeneticsGenomicsGMPGood Clinical Practice (GCP)Good Manufacturing Practice (GMP)Good Publication Practice (GPP)Grant Writinggrant writing and designHealthcareHistologyICH guidelinesImmunocytochemistry (ICC)ImmunofluorescenceImmunohistochemistryImmunohistochemistry (IHC)ImmunoassaysImmunologyImmunoprecipitationIMPDInformed Consent DocumentsInformed Consent ProcessInternational Project ManagementKOL managementLife SciencesLifesciencesMedical ImagingMedical oncology Medical writingMedicineMetabolismMicroscopyMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordMolecular & Cellular Biologymolecular biologyNeurologyNeuroscienceNew Drug Application (NDA)NutritiononcoOncologoncologyOncology Clinical ResearchOphthalmologyOutcome Measurement Study (OMS) OutlookPathologyPatient Follow UpPatient recruitmentPatient Reported Outcome Measures (PROMs)Patient Screening and RecruitmentPharmacodynamicsPharmacokineticspharmacologyPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PhotoshopPhysiologyPowerPointProblem SolvingPre-clinical researchPreclinical developmentPreclinical ResearchPresentation SkillsPresentationsPrinciples and ethics of clinical researchProblem-solving methods and troubleshootingProtocolPsychiatryRandomization and blindingPulmonary diseasesRandomization SystemsRate of drug eliminationRegulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory submissionsReport WritingResearchRespiratoryRheumatologyRisk AssessmentRisk ManagementRegistration of the productScientific CommunicationsScientific methodologyScientific WritingSearch literature on clinical trialsStandard Operating Procedure (SOP)Start-upsStudy approvalsStudy outcomes and outcome measuresStudy proposalsStudy protocolsSupervising CRAsTeachingTrainingTranslationTranslational MedicineTroubleshootingUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesWriting Study Procedures and SOPs NegotiationBiologyHuman AnatomyHealthcare industryMedical DevicesClinical Data Management (CDM)Clinical Trial Management System (CTMS)
Skills and Expertise
Analyze data Analytical skills Develop clinical trial protocols Develop protocols Guide students Interact with nurses Interact with physicians Design case record forms Create SOPs Interpret data Monitor a clinical study Report data Search literature on clinical trials Use a confocal microscopy Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust methodsAdjust processes Adjust processes and methodsAdminister logisticsAdminister supply requestAlzheimerApprove consent documentsApprove Label Master SheetApprove monitoring reportsApprove patient informationApprove queriesApprove suitability of patient information and consent documentsArchive documentationArchive study documentsAssign activitiesAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingAssure medical qualityAttend at steering committee meetingsAttend investigator meetingAttend seminarsassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Attend seminars, courses and meetings within and outside the companyAttend steering committeeBiomarker ResearchCalculate timelines for conducting and completing the trialCalculate trial timelinesCapture data on source documentscollaborate in research projects at universitiesCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with project teamCollect patient forms and questionnairesCommunicate with investigatorCommunicate with sponsorCommunicationCompile informationComplete case report form (CRF)Complete study proceduresConduct close-out visitsConduct literature searchesConduct literature searches.Conduct maintenance visitsConduct research at universitiesConduct studiesConduct site initiationConduct the trialConduct university research Confirm protocol complianceCommunicate effectively on different company levelsContact potential subjectsContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.Coordinate ethics committeeContract approvalCoordinate recallsControl protocol versionsCoordinate logisticsCoordinate projectsCoordinate with the ethics commiteecoordinating research projectsCoordinationCreate clinical documentsCreate study documentsCreate standard operating procedure (SOP)Coordinate regular advisory boardCreate clinical project documents according to the protocolCreate SOPsCreates a collaborative team environmentDesign case record form (CRF)Design clinical trialDesign efficiency studyDesign exclusion criteriaDesign inclusion criteriaDesign information leafletDesign protocolDesign protocolsDesign scientific experimentsDesign scientific projects (in biology)Design studiesDesign studyDesign study documentsDesign subject consent formDesign the studyDevelop protocolsDevelop study timelinesDevelop supply plansDevelop supply strategyDevelopment of Pharmacy manualDevelop training materialsDirect co-workersDirect co-workers to achieve resultDiscuss treatments with investigatorDistribute study documentsDistribute trial suppliesdrafting grant applicationsEnsure consistency between the protocol and CRFEnsure data consistencyEnsure good clinical practice (GCP)Establish professional relationships with partnersEstablish relationships with Key Opinion LeadersEthics committee applicationEthics committee submissionsEvaluate protocolsEvaluate stability data and impurity identification/synthesisExecute scientific projectsExtrapolate dataFacilitate sponsor monitoring visitsEvaluate stability data Follow up projectsFollow up training programsFollow-up of quality assurance activitiesGenerate regulatory submissions General office managementGuide staffGuide studentsHandle callsHandle incidentsIdentify and provide training to trial team and associated staffIdentify growth / improvement potentialIdentify investigatorsIdentify risksIdentify sitesIndentify clinicians to conduct clinical trialsInformed consent processInitiate clinical trials Interact with computer specialistsInteract with CROsInteract with ethics committeeInteract with KOLInteract with nursesInteract with pharmacistsInteract with physiciansInteract with pre-clinical scientistsInteract with regulatory stakeholdersInteract with statisticiansInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLabeling compliance with local regulationsLate-stage regulatory filing (MAA, BLA)Liaise with doctorsLiaise with doctors and other professionals throughout the studyLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record dataManage clinical trial files/documentsManage Clinical Trial Management System (CTMS) Manage clinical suppliesManage complexityManage budgetsManage contractors Manage multiple projectsManage projects resourcesManage publication strategy of clinical trial resultsManage regulatory activitiesManage research projectsManage study budgetManage study supplyManage subject consent formManage subject safetyManage trial master file (TMF)Manufacture of GMP batchesManuscript preparationManuscript preparation and reviewManuscript reviewNegotiate protocol details New indications of marketed drugObtain grantsOperate research equipmentOral presentationOrganise meetingsOrganise steering committeeOrganize scientific projects (in biology)Participate in medical reviewPatient recruitmentPlan experimentsPilot scale batchesPersuade clinicians to conduct clinical trialsPlan work to meet objectives and deadlinesPlanning clinical studiesPre-study procedures Prepare final reportPrepare investigator brochuresPrepare manuscriptPrepare regulatory documentsPrepare responses to health authority queriesPresent at steering committeePresent clinical resultsProtocol managementProvide benefit risk assessmentProvide input to process improvement initiativesProvide medical content for clinical development planProvide medical insightsProvide medical rationale of diseaseProvide support for scientific and/or technical projectsProvide technical supportProvide trainingPublication of articlesPublish scientific projectsProject probable outcomesR&DRead medical literatureRead medical literature to maintain current awareness and knowledgeRegulatory documentationRegulatory submissionsReport non-compliance incidentsReport deaths to regulatory authoritiesReport serious adverse events (SAE)Report study conclusionsReport technical problemsResearch at universitiesResolves queriesRespond to audit findingsRetrieve study documentsReview clinical study reportsReview data interpretationReview exclusion criteriaReview inclusion criteriaReview informed consent processReview manufacturing documentationReview medical reportsReview monitoring reportsReview protocolsReview queriesReview study protocolsReview the interpretation of dataSchedule sponsor monitoring visitsSchedule trial visitsScheduling trial visitsSearch literature on clinical trialsSelect contractors Select investigatorsScreen patientsSelect sitesSet up a clinical studySet up research projectsSetup of research equipmentShipment of biological specimenSite managementSolve problemsSpecimen processingStudy-related documentsSubmit regulatory applicationsSupervise clinical monitorsStudy execution planSupervise data processingSupervise PhD studentsSupervise techniciansSupervise trial suppliesSupport due diligence assessmentsTeach university studentsTeachingTrain off site staffTrain on site staffTrain StaffTranslate clinical research concepts into specific objectivesTranslate customer needs into analytical study proposal/protocolTranslate protocol into packaging and labeling requirementsUnderstand protocolsUpdate Clinical Trials Management System (CTMS) Work under specific instructionsWork with coordination and data management teamswrite and maintain clinical evaluation reportsWrite clinical evaluation reportsWrite combined statistical and medical reportsWrite documentsWrite final reportsWrite medical reportsWrite papersWrite statistical reportsWriting regulatory documentsWritten presentationMaintain strong relationships
Doctorate in Microvascular surgery (preclinical research) from Gregorio Marañon Hospital in 1989
Bachelor in Veterinary Medicine and Surgery from School Veterinary Medicine (UCM) in 1985
Training and Certification
Translator in 1989 Training
Clinical trials monitoring in 2006 Certification
Expert has 5 publications (Will be avalible with full profile)