BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Full-timeOn-siteSenior
Mainz, München
New Job?Nejo!
Your personal AI career agent
Developing portfolio documents and process improvements for novel drug trials. Project management and regulatory submission experience in drug development required. International project scope.
Requirements
- Natural/life sciences or medical background
- Knowledge of legislation and ICH-GCP guidelines
- Experience in project management and submissions
- Refined colloquial and correspondence skills
- Proficiency in standard office software
- Readiness to take responsibility
- Team leadership and motivation skills
- Problem recognition and solution skills
- Excellent organizational and communicative skills
- Independent and proactive working style
Tasks
- Lead and supervise clinical trial teams
- Develop portfolio documents and oversight plans
- Create process developments and trial RACIs
- Draft and update standard operating procedures
- Ensure adherence to ICH-GCP and regulatory guidelines
- Conduct training on relevant clinical procedures
- Act as the escalation point for project challenges
- Manage external vendors and sponsor department relations
- Line manage clinical trial managers and associate directors
- Plan team resources with the Senior Director
- Govern and oversee CROs and external vendors
- Direct vendor selection and strategic sourcing approaches
- Monitor project timelines and program deliverables
- Identify and address future program needs
- Organize and facilitate regular team meetings
- Identify high-performance members and foster team development
- Support the QA team during audits and inspections
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ICH-GCP
- Word
- Excel
- PowerPoint
- MS Project
Benefits
Competitive Pay
- Competitive remuneration packages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- BioNTech SE
Senior Director, Global Medical Affairs (Oncology)(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSeniorMainz
Developing portfolio documents and process improvements for novel drug trials. Project management and regulatory submission experience in drug development required. International project scope.
Requirements
- Natural/life sciences or medical background
- Knowledge of legislation and ICH-GCP guidelines
- Experience in project management and submissions
- Refined colloquial and correspondence skills
- Proficiency in standard office software
- Readiness to take responsibility
- Team leadership and motivation skills
- Problem recognition and solution skills
- Excellent organizational and communicative skills
- Independent and proactive working style
Tasks
- Lead and supervise clinical trial teams
- Develop portfolio documents and oversight plans
- Create process developments and trial RACIs
- Draft and update standard operating procedures
- Ensure adherence to ICH-GCP and regulatory guidelines
- Conduct training on relevant clinical procedures
- Act as the escalation point for project challenges
- Manage external vendors and sponsor department relations
- Line manage clinical trial managers and associate directors
- Plan team resources with the Senior Director
- Govern and oversee CROs and external vendors
- Direct vendor selection and strategic sourcing approaches
- Monitor project timelines and program deliverables
- Identify and address future program needs
- Organize and facilitate regular team meetings
- Identify high-performance members and foster team development
- Support the QA team during audits and inspections
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- ICH-GCP
- Word
- Excel
- PowerPoint
- MS Project
Benefits
Competitive Pay
- Competitive remuneration packages
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BioNTech SE and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
BioNTech SE
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Not a perfect match?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Full-timeOn-siteSeniorMainz, München - BioNTech SE
Senior Director, Global Medical Affairs (Oncology)(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Senior Director Protein Modality Lead(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Manager QA Compliance(m/w/x)
Full-timeOn-siteSeniorMainz - BioNTech SE
Executive Director Manufacturing Network QA(m/w/x)
Full-timeOn-siteSeniorMainz