2 jobs found in budapest

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    • budapest, budapest
    • permanent
    Pozíció leírása / Job descriptionSupport the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholdersYour main functions would be:Managing operational aspects of submission planning for assigned productssubmission planningdocument retrievalsubmission creation and delivery to Health AuthoritiesElvárások / RequirementsBachelors degree in a Life Science related discipline.High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).Affinity to work with complex IT systemsEnglish language knowledge, intermediate or aboveAt least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.Amit kínálunk / OfferA career path that will allow you to become a Subject Matter ExpertThe opportunity to work on different Regulatory processes across different projectsTrainings on various competencies and skillsLanguage courses and trainingOn-site relax & gym roomsVolunteering, sport and employee eventsKapcsolattartó / InformationDo you have any questions?If so, please contact me via eszter.csigo-tolnai@randstad.hu
    Pozíció leírása / Job descriptionSupport the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholdersYour main functions would be:Managing operational aspects of submission planning for assigned productssubmission planningdocument retrievalsubmission creation and delivery to Health AuthoritiesElvárások / RequirementsBachelors degree in a Life Science related discipline.High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).Affinity to work with complex IT systemsEnglish language knowledge, intermediate or aboveAt least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.Amit kínálunk / OfferA career path that will allow you to become a Subject Matter ExpertThe opportunity to work on different Regulatory processes across different projectsTrainings on various competencies and skillsLanguage courses and trainingOn-site relax & gym roomsVolunteering, sport and employee eventsKapcsolattartó / InformationDo you have any questions?If so, please contact me via eszter.csigo-tolnai@randstad.hu
    • budapest, budapest
    • permanent
    Pozíció leírása / Job descriptionYour responsibilities will include:Provides support and training on the Clinical data management activities to Data Managers for the relevant functional processes/work statements/projects Maintains and builds awareness of internal and external clinical Data Management practices to enhance domain expertiseOverall in-charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close OutPrimary point of contact for CDM and works are liaison for CP, DAS and CCS activities tooMonitors and evaluates overall study progress, identify the potential risk / challenges Conducts regular team meetings for study updates and provides guidance on study related issues to client as well internal teamsMonitor, maintain and report KPI / SLAs /metrics on the studyPerforms tasks/activities as communicated by the Group Leader (GL) and / or Project Manager (PM) Set priorities and targets of the study within the CP, DM, CCS, DAS teamsResponsible for ongoing monitoring and development of study team at functional level Elvárások / RequirementsAt least 2-3 years experience in this fieldGood knowledge of MS OfficeExcellent Technical skills, start-up knowledge is mustProject management & result orientationExcellent Planning and Organizing skillsExperience in Clinical Data Management is requiredStrong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminologyKnowledge of PL/SQL is an advantageAmit kínálunk / OfferA career path A great diversity of culturesLanguage courses and trainingOn-site relax & gym roomsKapcsolattartó / InformationDo you have any questions? If so, please contact me via eszter.csigo-tolnai@randstad.hu
    Pozíció leírása / Job descriptionYour responsibilities will include:Provides support and training on the Clinical data management activities to Data Managers for the relevant functional processes/work statements/projects Maintains and builds awareness of internal and external clinical Data Management practices to enhance domain expertiseOverall in-charge of all Data Management activities for a study/ies including Study Set up, Conduct and Close OutPrimary point of contact for CDM and works are liaison for CP, DAS and CCS activities tooMonitors and evaluates overall study progress, identify the potential risk / challenges Conducts regular team meetings for study updates and provides guidance on study related issues to client as well internal teamsMonitor, maintain and report KPI / SLAs /metrics on the studyPerforms tasks/activities as communicated by the Group Leader (GL) and / or Project Manager (PM) Set priorities and targets of the study within the CP, DM, CCS, DAS teamsResponsible for ongoing monitoring and development of study team at functional level Elvárások / RequirementsAt least 2-3 years experience in this fieldGood knowledge of MS OfficeExcellent Technical skills, start-up knowledge is mustProject management & result orientationExcellent Planning and Organizing skillsExperience in Clinical Data Management is requiredStrong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminologyKnowledge of PL/SQL is an advantageAmit kínálunk / OfferA career path A great diversity of culturesLanguage courses and trainingOn-site relax & gym roomsKapcsolattartó / InformationDo you have any questions? If so, please contact me via eszter.csigo-tolnai@randstad.hu

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