BioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Drafting regulatory documents for oncology and infectious disease drug development. Immunology and oncology background required. Up to 6 weeks vacation.
Anforderungen
- Relevant science/medical university degree (M.D., Pharm. D, or Ph.D.)
- Background knowledge in immunology and oncology
- Drug development experience in oncology/immunology
- Scientific and medical writer experience in pharma/biotech
- Drafting documents for multiple indications
- Drafting new/updated CTPs and CSRs for Phase I-III trials
- Drafting low/medium complexity variants of IBs, CTD modules, DSURs, RMPs, Response documents, Diversity Plans, PIPs/PSPs, CTD Module 1 documents
- Editing/reviewing R&D reports
- Drafting low/medium complexity variants of R&D reports from source data
- Ability to interpret and summarize scientific results clearly and concisely
- Excellent attention to detail
- Can-do attitude with ability to meet tight timelines and prioritize workload
- Interpersonal skills, motivation, coordination, and conflict resolution skills
- MS Word, MS 365 (TEAMS, SharePoint, PowerPoint, Excel), Adobe Acrobat Pro, and DMS author user skills
- Knowledge of relevant regulations/guidance on regulatory document structure/format (ICH E3, E6, E9, FDA guidance on BB, Diversity Plans, master protocols, EU CTR, GDPR)
- Knowledge of relevant technical specifications (ICH M4)
- Knowledge of drug development process and stakeholder needs
- Knowledge of statistics, trial design, data reporting, and outcome measures for immunotherapeutic agents (e.g., RECIST)
Aufgaben
- Write, edit, and format scientific and regulatory documents
- Coordinate document preparation, review, and approval
- Check and revise documents for scientific content and compliance
- Manage outsourced medical writing tasks
- Support external writers with SoW setup and coordination
- Foster knowledge of processes, templates, and standards
- Guide compliance with good writing practices
- Ensure adherence to international pharmaceutical requirements
- Support implementation of role-relevant tools and guidelines
- Perform complex medical writing tasks with limited supervision
- Adapt standard procedures for document creation
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Word
- MS 365
- SharePoint
- PowerPoint
- Excel
- Adobe Acrobat Pro
- DMS author
- ICH E3
- ICH E6
- ICH E9
- FDA guidance
- EU CTR
- GDPR
- ICH M4
- RECIST
Benefits
Attraktive Vergütung
- Competitive remuneration packages
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.
Noch nicht perfekt?
- BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Associate Director IT Infrastructure Services(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Translational Sciences (Infectious Diseases)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz, München - CSL Behring
Associate Director, Int’l Media Relations & DACH Communications(m/w/x)
Vollzeitnur vor OrtSeniorHattersheim, Marburg, München
BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Drafting regulatory documents for oncology and infectious disease drug development. Immunology and oncology background required. Up to 6 weeks vacation.
Anforderungen
- Relevant science/medical university degree (M.D., Pharm. D, or Ph.D.)
- Background knowledge in immunology and oncology
- Drug development experience in oncology/immunology
- Scientific and medical writer experience in pharma/biotech
- Drafting documents for multiple indications
- Drafting new/updated CTPs and CSRs for Phase I-III trials
- Drafting low/medium complexity variants of IBs, CTD modules, DSURs, RMPs, Response documents, Diversity Plans, PIPs/PSPs, CTD Module 1 documents
- Editing/reviewing R&D reports
- Drafting low/medium complexity variants of R&D reports from source data
- Ability to interpret and summarize scientific results clearly and concisely
- Excellent attention to detail
- Can-do attitude with ability to meet tight timelines and prioritize workload
- Interpersonal skills, motivation, coordination, and conflict resolution skills
- MS Word, MS 365 (TEAMS, SharePoint, PowerPoint, Excel), Adobe Acrobat Pro, and DMS author user skills
- Knowledge of relevant regulations/guidance on regulatory document structure/format (ICH E3, E6, E9, FDA guidance on BB, Diversity Plans, master protocols, EU CTR, GDPR)
- Knowledge of relevant technical specifications (ICH M4)
- Knowledge of drug development process and stakeholder needs
- Knowledge of statistics, trial design, data reporting, and outcome measures for immunotherapeutic agents (e.g., RECIST)
Aufgaben
- Write, edit, and format scientific and regulatory documents
- Coordinate document preparation, review, and approval
- Check and revise documents for scientific content and compliance
- Manage outsourced medical writing tasks
- Support external writers with SoW setup and coordination
- Foster knowledge of processes, templates, and standards
- Guide compliance with good writing practices
- Ensure adherence to international pharmaceutical requirements
- Support implementation of role-relevant tools and guidelines
- Perform complex medical writing tasks with limited supervision
- Adapt standard procedures for document creation
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – verhandlungssicher
Tools & Technologien
- MS Word
- MS 365
- SharePoint
- PowerPoint
- Excel
- Adobe Acrobat Pro
- DMS author
- ICH E3
- ICH E6
- ICH E9
- FDA guidance
- EU CTR
- GDPR
- ICH M4
- RECIST
Benefits
Attraktive Vergütung
- Competitive remuneration packages
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.
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 Digital Systems Compliance(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Director Global Regulatory Affairs (Oncology)(m/w/x)
Vollzeitnur vor OrtSeniorMainz, München - BioNTech SE
Associate Director IT Infrastructure Services(m/w/x)
Vollzeitnur vor OrtSeniorMainz - BioNTech SE
Associate Director Translational Sciences (Infectious Diseases)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMainz, München - CSL Behring
Associate Director, Int’l Media Relations & DACH Communications(m/w/x)
Vollzeitnur vor OrtSeniorHattersheim, Marburg, München