Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSenior
Schaftenau
ab 65.605,54 / Jahr
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NONovartis
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Representing GDPD in CMC sub-teams, managing device and packaging issues for drug-device combination products in the pharmaceutical sector. Master/PhD in science/engineering, with regulatory guidelines for drug-device combination products essential. Childcare facilities available.
Anforderungen
- Master or PhD in natural science, engineering, pharmaceutical field, or equivalent
- Minimum 2-4 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development
- Ability to work and lead a cross-functional team in a matrix environment
- Proven knowledge and track record in project and program planning and execution
- Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and cGMP
- Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker
- Fluency in English (oral and writing), German is beneficial
Aufgaben
- Represent GDPD in CMC sub-teams
- Lead device-related discussions and secure project strategy endorsements
- Act as the single point of contact for device and packaging issues
- Plan and manage project resources, schedules, and budgets
- Assess and negotiate internal and external resource needs
- Establish and maintain a high-quality Design History File
- Ensure compliance with internal processes and regulations
- Contribute to process and delivery technology improvements
- Evaluate device technology for different project phases
- Support internal and external audits on packaging and medical devices
- Assist in preparing regulatory dossiers for medical device registration
- Respond to health authority queries
Berufserfahrung
- 2 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Attraktive Vergütung
- Market-competitive base salary
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development opportunities
Karriere- und Weiterentwicklung
- Worldwide career possibilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis 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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NONovartis
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Representing GDPD in CMC sub-teams, managing device and packaging issues for drug-device combination products in the pharmaceutical sector. Master/PhD in science/engineering, with regulatory guidelines for drug-device combination products essential. Childcare facilities available.
Anforderungen
- Master or PhD in natural science, engineering, pharmaceutical field, or equivalent
- Minimum 2-4 years of experience in the pharmaceutical industry, preferably in drug-device combination product technical development
- Ability to work and lead a cross-functional team in a matrix environment
- Proven knowledge and track record in project and program planning and execution
- Understanding and awareness of regulatory guidelines for drug-device combination products, including relevant ISOs and cGMP
- Collaborative spirit, self-driven attitude, high level of learning agility, good listening skills, strategic thinker
- Fluency in English (oral and writing), German is beneficial
Aufgaben
- Represent GDPD in CMC sub-teams
- Lead device-related discussions and secure project strategy endorsements
- Act as the single point of contact for device and packaging issues
- Plan and manage project resources, schedules, and budgets
- Assess and negotiate internal and external resource needs
- Establish and maintain a high-quality Design History File
- Ensure compliance with internal processes and regulations
- Contribute to process and delivery technology improvements
- Evaluate device technology for different project phases
- Support internal and external audits on packaging and medical devices
- Assist in preparing regulatory dossiers for medical device registration
- Respond to health authority queries
Berufserfahrung
- 2 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Attraktive Vergütung
- Market-competitive base salary
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development opportunities
Karriere- und Weiterentwicklung
- Worldwide career possibilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis 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
Novartis
Branche
Pharmaceuticals
Beschreibung
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Device Project Leader - Combination Product Portfolio 3(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Engineering(m/w/x)
Vollzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert - Medical Device Analytical Representative(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorSchaftenauab 65.605,54 / Jahr