Merz Therapeutics
Team Lead Regulatory Affairs Regions(m/w/x)
Vollzeitmit HomeofficeSenior
Frankfurt am Main
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SASanofi-Aventis Deutschland GmbH
Submission Lead for Structured Data(m/w/x)
Frankfurt am Main
ab 83.856 - 111.808 / Jahr
Vollzeitmit HomeofficeSenior
jobs_badge_aiMl
Nejo KI-Zusammenfassung
End-to-end structured data operations management for a biopharma company, leading a team of specialists. 5+ years in pharma, with 3+ years in regulatory affairs or data roles required. 14-week paid family leave, high-quality healthcare.
Anforderungen
- 5+ years in pharmaceutical industry
- Minimum 3 years in regulatory affairs or regulatory data roles
- Strong knowledge of medicinal product information and global information standards
- Understanding of global regulatory environment and RIM systems
- Knowledge of pharmacovigilance regulations preferred
- Effective working relationships across departments
- Strong organizational and communication skills in matrix organizations
- Ability to multitask and work effectively in global teams
- Customer-focused and action-oriented approach
- Experience leading multidisciplinary teams and working with senior management
- Strong influence and leadership skills
- Ability to adapt to changing priorities while meeting project requirements
- Hands-on experience with structured data submission applications and RIM systems
- Degree in Life Sciences, Information Technology, or related field preferred
- Fluent English (spoken and written) required
- Additional languages desirable
Aufgaben
- Lead structured data operations end-to-end
- Manage the complete business process
- Lead a team of structured data specialists
- Identify trends, opportunities, and risks
- Create action plans and escalate issues
- Support analysis and planning for system transitions
- Lead global structured data implementation
- Monitor changes to global structured data standards
- Represent Sanofi in working groups
- Write responses to structured data questions
- Oversee quality control of company data
- Provide expertise during audits
- Support inspection processes
- Execute operational strategy
- Provide direction to the team
- Work with stakeholders to improve processes
- Monitor data quality and compliance
- Track Global Regulatory Operations KPIs
- Ensure KPI targets are met
- Report and escalate KPI issues
- Set up and monitor service agreements
- Manage team workload
- Identify and resolve project conflicts
- Stay current on system operations
- Consult with stakeholders on delays and risks
- Maintain expertise in structured data processes
- Support implementation of tool changes
- Help create quality documents
- Identify and resolve structured data process issues
- Complete other tasks assigned
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- RIM systems
Benefits
Sonstige Vorteile
- Well-thought-out benefits package
- Numerous prevention programs
Gesundheits- & Fitnessangebote
- High-quality healthcare
Sicherer Arbeitsplatz
- Long-term illness coverage
Großzügige Elternzeit
- 14-week paid family leave
Kinderbetreuung
- Childcare benefits
Mitarbeiterrabatte
- Company employee benefit programs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland GmbH 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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SASanofi-Aventis Deutschland GmbH
Submission Lead for Structured Data(m/w/x)
Frankfurt am Main
ab 83.856 - 111.808 / Jahr
Vollzeitmit HomeofficeSenior
jobs_badge_aiMl
Nejo KI-Zusammenfassung
End-to-end structured data operations management for a biopharma company, leading a team of specialists. 5+ years in pharma, with 3+ years in regulatory affairs or data roles required. 14-week paid family leave, high-quality healthcare.
Anforderungen
- 5+ years in pharmaceutical industry
- Minimum 3 years in regulatory affairs or regulatory data roles
- Strong knowledge of medicinal product information and global information standards
- Understanding of global regulatory environment and RIM systems
- Knowledge of pharmacovigilance regulations preferred
- Effective working relationships across departments
- Strong organizational and communication skills in matrix organizations
- Ability to multitask and work effectively in global teams
- Customer-focused and action-oriented approach
- Experience leading multidisciplinary teams and working with senior management
- Strong influence and leadership skills
- Ability to adapt to changing priorities while meeting project requirements
- Hands-on experience with structured data submission applications and RIM systems
- Degree in Life Sciences, Information Technology, or related field preferred
- Fluent English (spoken and written) required
- Additional languages desirable
Aufgaben
- Lead structured data operations end-to-end
- Manage the complete business process
- Lead a team of structured data specialists
- Identify trends, opportunities, and risks
- Create action plans and escalate issues
- Support analysis and planning for system transitions
- Lead global structured data implementation
- Monitor changes to global structured data standards
- Represent Sanofi in working groups
- Write responses to structured data questions
- Oversee quality control of company data
- Provide expertise during audits
- Support inspection processes
- Execute operational strategy
- Provide direction to the team
- Work with stakeholders to improve processes
- Monitor data quality and compliance
- Track Global Regulatory Operations KPIs
- Ensure KPI targets are met
- Report and escalate KPI issues
- Set up and monitor service agreements
- Manage team workload
- Identify and resolve project conflicts
- Stay current on system operations
- Consult with stakeholders on delays and risks
- Maintain expertise in structured data processes
- Support implementation of tool changes
- Help create quality documents
- Identify and resolve structured data process issues
- Complete other tasks assigned
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- RIM systems
Benefits
Sonstige Vorteile
- Well-thought-out benefits package
- Numerous prevention programs
Gesundheits- & Fitnessangebote
- High-quality healthcare
Sicherer Arbeitsplatz
- Long-term illness coverage
Großzügige Elternzeit
- 14-week paid family leave
Kinderbetreuung
- Childcare benefits
Mitarbeiterrabatte
- Company employee benefit programs
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland GmbH 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Noch nicht perfekt?
- Merz Therapeutics
Team Lead Regulatory Affairs Regions(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - Merz Therapeutics
Specialist Regulatory Operations(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main - IQVIA
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Senior Data Governance Consultant (Pharma)(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - Veeva Systems
OpenData Quality Manager(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main