Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
Außerdem verantworten Sie das Monitoring und Reporting des Deployment-Fortschritts am Standort und nehmen regelmäßig an den Project Support Community Meetings teil. Ihr Profil: Must-haves Abgeschlossenes Studium im Bereich Life Sciences, Pharmazie, Biologie, Chemie oder Regulatory Affairs – oder vergleichbare Qualifikation mit Berufserfahrung; auch als Regulatory Affairs Specialist (m/w/d), Regulatory Operations Specialist (m/w/d) oder RIM Data Specialist (m/w/d) sind Sie willkommen.
B. in Wirtschaftsingenieurwesen, Internationales Handelsmanagement, BWL, Supply Chain Management oder vergleichbarMehrjährige Berufserfahrung im GMP-regulierten Umfeld, idealerweise in der Pharmaindustrie oder pharmazeutischen Distribution z.B. als Compliance Manager, Regulatory Compliance Manager, GMP Compliance Manager / GMP Specialist, Project Manager / PMO Manager Quality & Compliance (m/w/d)Fundierte Kenntnisse in GxP, Quality Management, CAPA, Change ControlErfahrung im Projektmanagement (PMO-Strukturen)Sicherer Umgang mit SAP (idealerweise SAP BI) und MS OfficeSehr gute Deutsch- und Englischkenntnisse WIR GARANTIEREN IHNEN: Sie erwartet eine direkte Festanstellung bei unserem wertschätzenden Kunden.Um Sie bestmöglich bei unserem Kunden zu präsentieren, optimieren wir gemeinsam Ihre Bewerbungsunterlagen und bereiten Sie gründlich auf das Vorstellungsgespräch im Unternehmen vor.Damit Sie zu den besten Konditionen eingestellt werden, stehen wir Ihnen im Voraus zur Verhandlung Ihres Arbeitsvertrags beratend zur Seite.Darüber hinaus beraten wir Sie auch gern kostenfrei zu weiteren passenden Karrieremöglichkeiten.
Essential Functions Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.Develop contract language, payment language and budget templates as required as applicable to the positionUtilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreementsReport contracting performance metrics and out of scope contracting activities as required.Work with Quality Management to ensure appropriate contract management and quality standards.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas.
The IQVIA™ Internship provides you with the opportunity to gain relevant, project-based work experience at one of the most successful and cutting-edge global clinical research units in the market while building relationships within the company that will impact your future.
The IQVIA™ Internship provides you with the opportunity to gain relevant, project-based work experience at one of the most successful and cutting-edge global clinical research units in the market while building relationships within the company that will impact your future.
Study Physician services Medical Content Oversight: Responsible for medical content in Clinical Trial Protocols (CTPs).Collaborates with Project Management, Patient Safety, Medical Writers, and trial/evidence teams.Provides medical input for CTP updates. Risk-Based Quality Management: Defines medically critical data/processes and associated risks.Contributes to Integrated Quality and Risk Management Plan (IQRMP).Participates in risk discussions during trial conduct.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas.
The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas in Germany or the DACH region.
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