BioNTech SE
Associate Director Biostatistics(m/w/x)
Full-timeOn-siteSenior
Mainz
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BIBioNTech SE
Associate Director Scientific/Medical Writing(m/w/x)
Mainz
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- MS Word
- MS 365
- SharePoint
- PowerPoint
- Excel
- Adobe Acrobat Pro
- DMS author
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
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- MS Word
- MS 365
- SharePoint
- PowerPoint
- Excel
- Adobe Acrobat Pro
- DMS author
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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?
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