BioNTech SE
Associate Director Digital Systems Compliance(m/w/x)
Full-timeOn-siteSenior
Mainz, München
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BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Drafting regulatory documents for oncology and infectious disease drug development. Immunology and oncology background required. Up to 6 weeks vacation.
Requirements
- 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)
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Native
- German – Business Fluent
Tools & Technologies
- 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
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.
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BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
Drafting regulatory documents for oncology and infectious disease drug development. Immunology and oncology background required. Up to 6 weeks vacation.
Requirements
- 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)
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Native
- German – Business Fluent
Tools & Technologies
- 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
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
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