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Medical Excellence Manager(m/w/x)
Teilzeitmit HomeofficeBerufserfahren
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BOBoehringer Ingelheim
Senior Global Submission Manager(m/w/x)
Ingelheim am Rhein, Biberach
Teilzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global regulatory submissions (CTA/IND, NDA/BLA, MAA) planning, coordination, and content plan development at a global pharmaceutical company. Hands-on experience with RIM platforms (VeevaVault, Aris Global, Ennov) essential. Hybrid work setup.
Anforderungen
- University degree in Life Sciences, Pharmacy, Medical Informatics, Regulatory Affairs, Biomedical Engineering, or related discipline
- Several years experience in regulatory submissions, digital regulatory operations, RIM processes, document lifecycle management, or project management in GxP environment
- Sound understanding of CTD/eCTD requirements, global regulatory guidelines, and document management standards
- Strong affinity for digital systems and hands-on experience with RIM platforms (VeevaVault, Aris Global, Ennov)
- Experience with eCTD publishing tools and familiarity with structured content management or metadata-driven processes
- Proficiency with reporting/analytics tools (PowerBI, Tableau) and project management applications (MSProject, Jira, Smartsheet)
- Strong analytical skills, structured working approach, and ability to convert process gaps into improvement initiatives
- Excellent collaboration skills and ability to operate effectively in international, cross-functional teams
Aufgaben
- Plan global regulatory submissions (CTA/IND, NDA/BLA, MAA)
- Coordinate global regulatory submissions (CTA/IND, NDA/BLA, MAA)
- Deliver global regulatory submissions (CTA/IND, NDA/BLA, MAA)
- Develop Global Submission Content Plans
- Maintain Global Submission Content Plans
- Promote transparency and alignment across functions
- Drive cross-regional collaboration
- Apply global regulatory standards
- Leverage digital tools (e.g., RIM, eCTD platforms)
- Shape global submission processes, SOPs, and governance
- Improve global submission processes, SOPs, and governance
- Identify automation opportunities
- Support metadata-driven workflow enhancements for efficiency, data integrity
- Conduct root-cause analyses
- Contribute to continuous improvement initiatives (Lean, Kaizen)
- Support global project management activities
- Track project milestones
- Manage project risks
- Communicate effectively with stakeholders
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- VeevaVault
- Aris Global
- Ennov
- eCTD publishing tools
- PowerBI
- Tableau
- MSProject
- Jira
- Smartsheet
Benefits
Flexibles Arbeiten
- Hybrid work setup
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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BOBoehringer Ingelheim
Senior Global Submission Manager(m/w/x)
Ingelheim am Rhein, Biberach
Teilzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Global regulatory submissions (CTA/IND, NDA/BLA, MAA) planning, coordination, and content plan development at a global pharmaceutical company. Hands-on experience with RIM platforms (VeevaVault, Aris Global, Ennov) essential. Hybrid work setup.
Anforderungen
- University degree in Life Sciences, Pharmacy, Medical Informatics, Regulatory Affairs, Biomedical Engineering, or related discipline
- Several years experience in regulatory submissions, digital regulatory operations, RIM processes, document lifecycle management, or project management in GxP environment
- Sound understanding of CTD/eCTD requirements, global regulatory guidelines, and document management standards
- Strong affinity for digital systems and hands-on experience with RIM platforms (VeevaVault, Aris Global, Ennov)
- Experience with eCTD publishing tools and familiarity with structured content management or metadata-driven processes
- Proficiency with reporting/analytics tools (PowerBI, Tableau) and project management applications (MSProject, Jira, Smartsheet)
- Strong analytical skills, structured working approach, and ability to convert process gaps into improvement initiatives
- Excellent collaboration skills and ability to operate effectively in international, cross-functional teams
Aufgaben
- Plan global regulatory submissions (CTA/IND, NDA/BLA, MAA)
- Coordinate global regulatory submissions (CTA/IND, NDA/BLA, MAA)
- Deliver global regulatory submissions (CTA/IND, NDA/BLA, MAA)
- Develop Global Submission Content Plans
- Maintain Global Submission Content Plans
- Promote transparency and alignment across functions
- Drive cross-regional collaboration
- Apply global regulatory standards
- Leverage digital tools (e.g., RIM, eCTD platforms)
- Shape global submission processes, SOPs, and governance
- Improve global submission processes, SOPs, and governance
- Identify automation opportunities
- Support metadata-driven workflow enhancements for efficiency, data integrity
- Conduct root-cause analyses
- Contribute to continuous improvement initiatives (Lean, Kaizen)
- Support global project management activities
- Track project milestones
- Manage project risks
- Communicate effectively with stakeholders
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- VeevaVault
- Aris Global
- Ennov
- eCTD publishing tools
- PowerBI
- Tableau
- MSProject
- Jira
- Smartsheet
Benefits
Flexibles Arbeiten
- Hybrid work setup
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Boehringer Ingelheim erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Boehringer Ingelheim
Branche
Pharmaceuticals
Beschreibung
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Noch nicht perfekt?
- AbbVie
Medical Excellence Manager(m/w/x)
Teilzeitmit HomeofficeBerufserfahrenWiesbaden - Henkell Freixenet
Product Information Consultant (PIM)(m/w/x)
Vollzeit/Teilzeitmit HomeofficeKeine AngabeWiesbaden - Henkell Freixenet
IT Project Manager - Digital Transformation(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorWiesbaden - HUMAN Gesellschaft für Biochemica und Diagnostica-mbH
Post Market Surveillance Manager(m/w/x)
Teilzeit/MinijobBefristeter Vertragmit HomeofficeBerufserfahrenWiesbaden - Merck & Co., Inc.
Werkstudent Preclinical Development(m/w/x)
TeilzeitWerkstudentmit HomeofficeSchwabenheim an der Selz