Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Vollzeitnur vor OrtSenior
Biberach, Ingelheim am Rhein
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
NONovartis
Global Program Safety Lead(m/w/x)
Seelbach
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Expert input and strategy for clinical development initiatives and products, leading risk management teams. Medical Degree and 5 years drug development experience required. International collaboration across diverse multinational teams.
Anforderungen
- Medical Degree or equivalent
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development
- Experience in clinical trial methodology and regulatory requirements
- Expertise in clinical safety assessments and regulatory submissions
- Experience with issue management
- Experience in leading cross-functional teams
- Fluent English (both spoken and written)
- Additional languages are an advantage
- Experience in Clinical Research and Clinical Trials
- Experience in Leadership and Medical Strategy
Aufgaben
- Provide expert safety input for clinical development programs
- Participate in the Global Program Team, Global Clinical Team, and Clinical Trial Team
- Lead the Safety Management Team
- Manage safety issues throughout the project lifecycle
- Own the safety strategy for projects and products
- Produce medical safety deliverables
- Develop and maintain safety information in the Core Data Sheet
- Address safety issues across all project and product indications
- Oversee signal detection and monitoring of safety information
- Evaluate and interpret safety data from relevant sources
- Prepare safety strategies for health authority responses
- Collaborate with project team members on safety inquiries
- Respond to regulatory authorities and healthcare professionals regarding safety issues
- Contribute to departmental and functional goals and objectives
- Engage in developing competencies within the Medical Safety Function
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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.
Noch nicht perfekt?
- Novartis
Head Finance Operations & Compliance - Global Health(m/w/x)
Vollzeitnur vor OrtSeniorSeelbach - Novartis
Senior Design Engineer(m/w/x)
Vollzeitnur vor OrtSeniorSeelbach - Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Vollzeitnur vor OrtSeniorIngelheim am Rhein, Biberachab USD 80.000 - 100.000 / Jahr
NONovartis
Global Program Safety Lead(m/w/x)
Seelbach
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Expert input and strategy for clinical development initiatives and products, leading risk management teams. Medical Degree and 5 years drug development experience required. International collaboration across diverse multinational teams.
Anforderungen
- Medical Degree or equivalent
- 3 years clinical experience postdoctoral
- Minimum 5 years experience in drug development
- Experience in clinical trial methodology and regulatory requirements
- Expertise in clinical safety assessments and regulatory submissions
- Experience with issue management
- Experience in leading cross-functional teams
- Fluent English (both spoken and written)
- Additional languages are an advantage
- Experience in Clinical Research and Clinical Trials
- Experience in Leadership and Medical Strategy
Aufgaben
- Provide expert safety input for clinical development programs
- Participate in the Global Program Team, Global Clinical Team, and Clinical Trial Team
- Lead the Safety Management Team
- Manage safety issues throughout the project lifecycle
- Own the safety strategy for projects and products
- Produce medical safety deliverables
- Develop and maintain safety information in the Core Data Sheet
- Address safety issues across all project and product indications
- Oversee signal detection and monitoring of safety information
- Evaluate and interpret safety data from relevant sources
- Prepare safety strategies for health authority responses
- Collaborate with project team members on safety inquiries
- Respond to regulatory authorities and healthcare professionals regarding safety issues
- Contribute to departmental and functional goals and objectives
- Engage in developing competencies within the Medical Safety Function
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
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?
- Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NCE(m/w/x)
Vollzeitnur vor OrtSeniorBiberach, Ingelheim am Rhein - Novartis
Head Finance Operations & Compliance - Global Health(m/w/x)
Vollzeitnur vor OrtSeniorSeelbach - Novartis
Senior Design Engineer(m/w/x)
Vollzeitnur vor OrtSeniorSeelbach - Boehringer Ingelheim
Senior Regulatory Affairs Manager CMC for NBE(m/w/x)
Vollzeitnur vor OrtSeniorIngelheim am Rhein, Biberachab USD 80.000 - 100.000 / Jahr