Senior Medical Writer社

15K-20K/月

市辖区

发布时间：2023-09-06

职位描述

职位描述：

PURPOSE
Takealeadingroleinpreparingorcontributingtotheproductionofmosttypesofclinicaldocuments,methodvalidationandstudydatareports,sitemanuals,orpostersforeitherinternalQuintilescustomersorexternalclients,forinvestigationaldrugs,biologicals,ormedicaldevices.ActsasmentorforlessexperiencedMedicalWritersandassistsintheirtraininganddevelopment.Participatesinprojectteams.
RESPONSIBILITIES
？ActsasLeadMedicalWriteronmosttypesofwritingproject,withlimitedguidancefromseniorstaff.Takesresponsibilityforpreparationofassigneddocumentstoahighstandard,workinginaccordancewithQuintilesSOPsandthecustomer'srequirements.Participatesinbothinternalandexternalprojectteammeetingsandliaisesdirectlywiththecustomeronmedicaland/ortechnicalwritingissues,asappropriateandwithseniorsupportasneeded.Identifiesprojectneeds,negotiatesandtracksprojecttimelines,andimplementsclientrequestswithlimitedseniorguidance.Arrangesappropriateinternalreviewofassigneddocumentsandtakesresponsibilityforon-timedelivery.Takesresponsibilityforplanningandorganizingworkloadforassignedprojectsandtasks.Offersproactivesolutionsandadvicetocustomersasappropriatetoexperience.
？Reviewsandmonitorsbudgetforassignedprojects,includingoutofscopeactivities,andensuresthatrevenueisrecognisedasappropriate.Mayreviewballparkbudgetsandroutinecostings,withmanagementsupportasneeded.
？MayreviewdocumentsorpartsofdocumentspreparedbyotherMedicalWritersandprovideappropriatefeedback.GivesguidancetolessexperiencedMedicalWritersandassistsintheirtraininganddevelopment.
？Maypresentonstandardmedicaland/ortechnicalwritingprocessesatfull-servicebiddefencemeetingsbytelephoneorinperson.Mayinputintoanddeliverpresentationsonmedical/technicalwritingtootherQuintilesgroups.
？MayactasProjectManagerforasmallstand-alonemedicaland/ortechnicalwritingproject(e.g.protocolorCSR).Maycoordinatemedicaland/ortechnicalwritingactivitiesforaseriesoffull-serviceprojects,withattendantfocusonefficiencies,consistency,budgetaryconcerns,clientliaison,andtracking.
？Keepsabreastofcurrentdata,trends,medicaland/ortechnicalwriting/regulatoryknowledge,developmentsandadvancesinareaofdrugdevelopment/medicaland/ortechnicalwriting.
？MayproposerevisionstoSOPsorsuggestprocessimprovementsforconsideration.ComplieswithCompanySOPsandparticipatesintheimplementationofnewSOPs.
REQUIREDKNOWLEDGE,SKILLSANDABILITIES
？ExcellentstandardofwrittenEnglish,andabilitytocommunicatefluentlyandeffectivelyinEnglish,bothinwritingandverbally.
？In-depthknowledgeofthestructuralandcontentrequirementsofclinicalormethodvalidationandstudyreports,protocols,andsimilardocumentsforinternalandexternalclients.
？Abilitytointegrate,interpret,andsummarizedatafromavarietyofsourcesinaclearandconcisemanner.
？Demonstratedabilityandexperiencetoworkindependentlyonmostwritingprojects,withlimitedseniorguidance.
？Goodunderstandingofcommonstatisticalmethodsusedinclinicaltrialsorpharmaceuticalworkand/orinterpretationoftheirresults.
？Understandingofthetimeneededtoperformroutinemedicaland/ortechnicalwritingtasksinordertoagreeonappropriatetimelinesandprovideaccurateresourceestimatesandcostings.Knowledgeandunderstandingofnecessarybudgetassumptions.
？Abilitytogiveapresentationtoaprojectteamand/orcustomeronproject-specifictopics,withanairofcompetenceand
authority.
？Abilitytoidentifydeficiencies,errors,andinconsistenciesinaprotocolorreport.
？Abilitytoeffectivelyreviewastatisticalanalysisplanandtoidentifydeficiencies,errors,andinconsistenciesinstatisticaloutputasrelatedtoacceptancecriteriaaccordingtoSOPs.
？Developingskillsinprovidingeffectiveandsensitivewrittenandverbalfeedbacktojuniorstaff,andtocustomerswhenappropriate.
？Confidentandeffectivecommunicationandnegotiationskillswithcustomersandprojectmanagers.
？Developingskillsinchairingsmallmeetings.
？Abilitytoworkonseveralprojectsatoncewhilebalancingmultipleandoverlappingtimelines.
？Abilitytoassessandprioritizeworkload.
？Demonstratedabilitiesincollaborationwithothersandindependentthought.
？Knowledgeofregulationsrelevanttomedical/technicalwriting,suchasGoodLaboratoryPractices(GLP)andotherrelevantregulatoryagencies(e.g.,OECD,MHLW).
？Carefulattentiontodetailandaccuracy.
？Mustbecomputerliterate.
？Abilitytoestablishandmaintaineffectiveworkingrelationshipswithcoworkers,managersandclients.

其他要求

招聘人数：1人
职能类别：临床协调员CRC

公司介绍

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