医学负责人岗位职责

医学撰写负责人工作职责(该岗位主要负责的工作内容和承担的责任)

Author,co-author,criticallyedit,andformatregulatorydocumentsincludingNDAs,MAAs,INDs,protocols,CSRs,InvestigatorBrochures,annualreports,briefingdocuments,andotherregulatorysubmissions;

·Author,co-author,andcriticallyeditpublicationsincludingabstracts,posters,slidepresentations,manuscripts,andreviewarticles;

·Managemedicalwritingcontractedwithindependentconsultants,CROs,andothercommunicationvendors;

·Manageoverallmedicalwritingtimelinesandresourcesacrossprojectteams(includinginternalandexternalresources);

·Serveasthefunctionalarealeadonprojectteamsandadvisesuchteamsoncontent,format,andstyle-guiderequirementsfordocuments;

·Leadthedevelopmentofmedicalwritingprocesses,SOPs,workinstructions,anddocumentqualitycontrol;

·Participateinthedevelopmentofpublicationplans;

·Managethehiring,supervising,mentoring,anddevelopmentofinternalmedicalwritingstaffasthefunctionexpands;

·Maintainsubjectareaexpertiserelatedtothecompany’sinvestigationalproducts,diseaseindications,andregulatoryandpublicationguidelines;

·Developabudgetforthemedicalwritingdepartment;and

·Willingnesstoperformmiscellaneousjob-relateddutiesandadditionaldutiesandresponsibilitiesasassigned.

任职资格(该岗位需要具备什么样的要求)

Knowledge,SkillsandAbilitiesRequired:

·Advanceddegreeinlifesciencesrequired(MS,PhD,PharmD,orequivalent);

·5yearsormoreofmedicalwritingexperienceinthepharmaceuticalorbiotechnologyindustry;

·Demonstratedsuccessmanagingmedicalwriters(in-houseandcontract);

·Previousleadershiproleinmajorregulatoryfilings(NDA,BLA,MAA);

·Excellentabilitytointerpretandpresentscientificandclinicaltrialdataandunderstandstatisticalanalyses;

·Excellentwritingskillscoupledwithcomprehensiveknowledgeofthedrugdevelopmentprocessandregulatoryguidelines;

·Effectivecollaboratorpossessingtheabilitytofosterstrongworkingrelationshipsandbuildconsensuswithinmultidisciplinaryteams;

·Demonstratedinitiativeandtheabilitytomanageavarietyofprojectssimultaneouslywithminimalsupervision;

·Excellentinterpersonalandcommunicationskills;

·AdvancedknowledgeofclinicalandregulatorydocumentsandpublicationpracticesincludingCFDA,GCP,andICH;and

·ExpertuserofMicrosoftWord,PowerPoint,andExcel

•KeyCompetencies:

Professionalismandcustomerserviceorientation

·Communicationskills-writtenandverbal–MandarinandEnglishhighlypreferred

·Planning,organizingandmulti-tasking

·Prioritizingandtimemanagement

·Problemassessmentandproblemsolving

·Informationgatheringandinformationmonitoring

·Attentiontodetailandaccuracy

·Flexibility,adaptabilityandteamwork

工作职责(该岗位主要负责的工作内容和承担的责任)

Author,co-author,criticallyedit,andformatregulatorydocumentsincludingNDAs,MAAs,INDs,protocols,CSRs,InvestigatorBrochures,annualreports,briefingdocuments,andotherregulatorysubmissions;

·Author,co-author,andcriticallyeditpublicationsincludingabstracts,posters,slidepresentations,manuscripts,andreviewarticles;

·Managemedicalwritingcontractedwithindependentconsultants,CROs,andothercommunicationvendors;

·Manageoverallmedicalwritingtimelinesandresourcesacrossprojectteams(includinginternalandexternalresources);

·Serveasthefunctionalarealeadonprojectteamsandadvisesuchteamsoncontent,format,andstyle-guiderequirementsfordocuments;

·Leadthedevelopmentofmedicalwritingprocesses,SOPs,workinstructions,anddocumentqualitycontrol;

·Participateinthedevelopmentofpublicationplans;

·Managethehiring,supervising,mentoring,anddevelopmentofinternalmedicalwritingstaffasthefunctionexpands;

·Maintainsubjectareaexpertiserelatedtothecompany’sinvestigationalproducts,diseaseindications,andregulatoryandpublicationguidelines;

·Developabudgetforthemedicalwritingdepartment;and

·Willingnesstoperformmiscellaneousjob-relateddutiesandadditionaldutiesandresponsibilitiesasassigned.

任职资格(该岗位需要具备什么样的要求)

Knowledge,SkillsandAbilitiesRequired:

·Advanceddegreeinlifesciencesrequired(MS,PhD,PharmD,orequivalent);

·5yearsormoreofmedicalwritingexperienceinthepharmaceuticalorbiotechnologyindustry;

·Demonstratedsuccessmanagingmedicalwriters(in-houseandcontract);

·Previousleadershiproleinmajorregulatoryfilings(NDA,BLA,MAA);

·Excellentabilitytointerpretandpresentscientificandclinicaltrialdataandunderstandstatisticalanalyses;

·Excellentwritingskillscoupledwithcomprehensiveknowledgeofthedrugdevelopmentprocessandregulatoryguidelines;

·Effectivecollaboratorpossessingtheabilitytofosterstrongworkingrelationshipsandbuildconsensuswithinmultidisciplinaryteams;

·Demonstratedinitiativeandtheabilitytomanageavarietyofprojectssimultaneouslywithminimalsupervision;

·Excellentinterpersonalandcommunicationskills;

·AdvancedknowledgeofclinicalandregulatorydocumentsandpublicationpracticesincludingCFDA,GCP,andICH;and

·ExpertuserofMicrosoftWord,PowerPoint,andExcel

•KeyCompetencies:

Professionalismandcustomerserviceorientation

·Communicationskills-writtenandverbal–MandarinandEnglishhighlypreferred

·Planning,organizingandmulti-tasking

·Prioritizingandtimemanagement

·Problemassessmentandproblemsolving

·Informationgatheringandinformationmonitoring

·Attentiontodetailandaccuracy

·Flexibility,adaptabilityandteamwork