职位描述
职位描述: GeneralSummary: ThepurposeofthepositionistostrategicallyprovidemedicalsupportforbusinessdevelopmentandensurethehealthcompliancefromtheaspectofmedicalgovernanceofJJMC/JJMS/HCS. Responsibility: ?ToensureHealthCareComplianceonpromotionalmaterialandHealthCareProfessionalqualificationinaccordancewithJ&Jpolicy,JJMC/JJMS/HCSGOP/SOPandrelatedworkingprocedure. ?ToworkwithappropriateJJMC/JJMS/HCSpersonneltoguaranteethatalltheinformationregardingAdverseEventsinthefieldiscollectedtofacilitateacorrectandtransparentcommunicationofAdverseEventsinternally,andproperlyreviewtheAdverseEvents.EvaluateandsubmitthereportableAdverseEventstothecompetentHealthAuthoritiesincompliancewiththecompanysproceduresandthelocalregulations.KeepgooddocumentationonAdverseEventreportedtothecompetentHealthAuthorities. ?Tocollectinvestigatorsproposals(IIS)forlocalandregionalclinicalactivities,ensurethattheseproposalsarediscussedwithinthelocalclinicaltrialreviewcommittee,manageAsiaPacificandGlobalFranchiseapprovalprocesses,andprovidetimelyfeedbacktoinvestigators.Coordinateandtracktheprogressoncontracting,projectconductionandreportingafterIISapprovalfromlocal,regionalandgloballevel. ?Todevelopandmaintaincontactswithexternalexperts,inaccordancewiththestrategydevelopedbythecompanytofurtherunderstandandgainbothinsightand/orinputintotreatmentpatterns,includingthescientificactivitiestakingplacewithinthediseasearea,andtheneedsandbehaviorsofhealthcareproviders. ?Toprovidestrategicmedicalsupporttotheclinicalresearchoperationteamonmedicalactivitiesrelatingtotheconductofatrialorsurvey,e.g.protocolpreparation,safetyreview,studyreportwritingandpublication.Maintainscientificcontactswithlocalinvestigators. ?ToprovidestrategicinputonclinicalevidencegenerationanddisseminationtosupportfranchisebusinessdevelopmentbyutilizingEBMtool. ?TodevelopanunderstandingSOPsandproperworkinginstructionstoensuretheinternalprocessareincompliancewithcompanypolicyandrelatedregulation. ?Otherresponsibilitiesdefinedinwrittenprocedures. BasicRequirement; includingEducationand/orKnowledgeand/orTrainingand/orkeyRelevantExperiencerequired. PersonalRequirements(includeexperience,knowledge,skillsandeducation) -Atleastmasterdegreeofmedicine,bioengineeringorlifescience -Atleast4years’experiencepracticingmedicineorproductdevelopexperience -Industryexperienceinpharmaceuticalmarketing,clinicaloperation,ormedicalaffairswouldbepreferred. -GoodcommunicateskillsinEnglish,bothorallyandinwriting. -Havinggoodco-operationabilitiesandapositivecharacter. RequiredCompetencies -Clinicaltrialexpertise3 -Statistics&dataanalysis2 -Diseaseareaknowledge4 -Product/Procedure/Therapeuticareaknowledge4 -Scientificpresentation&publication3 -Customer&marketinsight3 -Managingcustomer&internalpartners3 -Culturaldiversity3 -ProjectManagement3联系时,请记得是在“job669人才”看到的!