BioNTech SE
Associate Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
Neuer Job?Nejo!
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BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Writing, editing, and coordinating regulatory submission documents for novel immunotherapies. 5+ years of scientific and medical writing experience required. Support, train, and guide team members.
Anforderungen
- Relevant science/medical university degree (MD, PharmD, PhD)
- Background knowledge in immunology and oncology
- Drug development experience in relevant field
- Oncology and/or immunology experience
- Scientific and medical writer experience
- Pharmaceutical/biotech industry experience
- Drafting documents for multiple indications
- Drafting documents for BioNTech-relevant indications
- Drafting new/updated CTPs and CSRs for Phase I-III trials
- Drafting low to medium complexity variants of IBs, CTD modules, DSURs/Annual Reports, RMPs, Response documents, Diversity Plans, PIPs/PSPs, CTD Module 1 documents
- Editing/reviewing R&D reports
- Drafting low to medium complexity variants of R&D reports
- Native-level written and spoken English
- Good German skills
- Ability to interpret and summarize scientific results clearly
- Excellent attention to detail
- Can-do attitude
- Ability to work to tight timelines
- Ability to prioritize workload
- Focus on delivery and adding value
- Advanced interpersonal skills
- Advanced motivation skills
- Advanced coordination skills
- Advanced conflict resolution skills
- MS Word skills
- MS 365 software skills (TEAMS, SharePoint, PowerPoint & Excel)
- Adobe Acrobat Pro skills
- DMS author user skills
- Good knowledge of relevant regulations/guidance on regulatory documents (ICH E3, E6, E9, FDA guidance)
- Good knowledge of relevant technical specifications (ICH M4)
- Good knowledge of drug development process
- Good knowledge of stakeholder needs
- Experience in other related roles
- Knowledge of statistics, trial design, data reporting, outcome measures
Aufgaben
- Write, edit, and format documents
- Coordinate document preparation, review, and approval
- Check and revise documents for scientific content, completeness, and consistency
- Manage outsourced tasks, including planning and coordinating with external writers
- Support, train, and guide team members
- Ensure compliance with relevant processes, templates, and standards
- Adhere to good writing practices and formatting requirements
- Comply with international pharmaceutical guidelines, regulations, and laws
- Support implementation of role-relevant tools, guidelines, and training materials
- Perform complex medical writing tasks with limited supervision
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Tools & Technologien
- MS Word
- MS 365
- SharePoint
- PowerPoint
- Excel
- Adobe Acrobat Pro
- DMS author
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE 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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BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Writing, editing, and coordinating regulatory submission documents for novel immunotherapies. 5+ years of scientific and medical writing experience required. Support, train, and guide team members.
Anforderungen
- Relevant science/medical university degree (MD, PharmD, PhD)
- Background knowledge in immunology and oncology
- Drug development experience in relevant field
- Oncology and/or immunology experience
- Scientific and medical writer experience
- Pharmaceutical/biotech industry experience
- Drafting documents for multiple indications
- Drafting documents for BioNTech-relevant indications
- Drafting new/updated CTPs and CSRs for Phase I-III trials
- Drafting low to medium complexity variants of IBs, CTD modules, DSURs/Annual Reports, RMPs, Response documents, Diversity Plans, PIPs/PSPs, CTD Module 1 documents
- Editing/reviewing R&D reports
- Drafting low to medium complexity variants of R&D reports
- Native-level written and spoken English
- Good German skills
- Ability to interpret and summarize scientific results clearly
- Excellent attention to detail
- Can-do attitude
- Ability to work to tight timelines
- Ability to prioritize workload
- Focus on delivery and adding value
- Advanced interpersonal skills
- Advanced motivation skills
- Advanced coordination skills
- Advanced conflict resolution skills
- MS Word skills
- MS 365 software skills (TEAMS, SharePoint, PowerPoint & Excel)
- Adobe Acrobat Pro skills
- DMS author user skills
- Good knowledge of relevant regulations/guidance on regulatory documents (ICH E3, E6, E9, FDA guidance)
- Good knowledge of relevant technical specifications (ICH M4)
- Good knowledge of drug development process
- Good knowledge of stakeholder needs
- Experience in other related roles
- Knowledge of statistics, trial design, data reporting, outcome measures
Aufgaben
- Write, edit, and format documents
- Coordinate document preparation, review, and approval
- Check and revise documents for scientific content, completeness, and consistency
- Manage outsourced tasks, including planning and coordinating with external writers
- Support, train, and guide team members
- Ensure compliance with relevant processes, templates, and standards
- Adhere to good writing practices and formatting requirements
- Comply with international pharmaceutical guidelines, regulations, and laws
- Support implementation of role-relevant tools, guidelines, and training materials
- Perform complex medical writing tasks with limited supervision
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Tools & Technologien
- MS Word
- MS 365
- SharePoint
- PowerPoint
- Excel
- Adobe Acrobat Pro
- DMS author
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE 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
BioNTech SE
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
Noch nicht perfekt?
- BioNTech SE
Associate Director Biostatistics(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Potency Assays - AS&T Lifecycle Management(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Manager Statistical Programming(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz - BioNTech SE
Associate Director Statistical Programming (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - CSL Behring
Associate Director, Int’l Media Relations & DACH Communications(m/w/x)
Vollzeitnur vor OrtSeniorHattersheim, Marburg, München