BioNTech AG is pioneering the development of individualized therapies for cancer and other diseases. We have the tools to develop individualized immunotherapy solutions under one roof – from diagnostics and drug development to manufacturing. The cutting-edge technologies that we are developing include individualized mRNA-based medicines, innovative chimeric antigen receptors and T-cell receptor-based treatments, and novel checkpoint immuno-modulators. BioNTech AG is Europe’s largest privately held biopharmaceutical company and has grown rapidly to more than 850 employees.
Senior Medical Writer (m/f)
Here, you’ll achieve greatness.As senior medical writer, you will assure the timely generation of high-quality regulatory documents required for the clinical development of novel immunotherapeutic agents. You will be part of an international scientific/medical writing team that closely collaborates with project management, clinical operations, and the non-clinical development team. The position will be based at our headquarters in Mainz, with the option of working partially from home.
- Write and edit clinical documents in accordance with appropriate national and international guidelines (e.g. ICH, EU)
- Establish and maintain internal processes for medical writing
- Share your clinical writing expertise with colleagues
- Collaborate with external service providers
- Prepare clinical abstracts, posters and manuscripts
What you have to offer.
- 5+ years’ experience as regulatory medical writer in the pharmaceutical/biotech industry
- MD or Ph.D. in a relevant life science, ideally with expert knowledge of immunology and oncology
- Ability to interpret and summarize complex clinical data in a clear and concise manner
- Proficiency authoring clinical regulatory documents, e.g. clinical study reports, study protocols, investigator’s brochures, briefing books and responses to authorities
- Native-level command of English is required, and good German skills are advantageous
- Excellent attention to detail
- Ability to work according to strict timelines and prioritize workload
- Expert user of MS Office applications
- Team player