BioNTech SE 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, novel checkpoint immuno-modulators, innovative chimeric antigen receptors and T-cell receptor-based treatments. BioNTech SE is Europe’s largest privately held biopharmaceutical company and has grown rapidly to more than 1000 employees.
Head of Scientific / Medical Writing*
Here, you’ll achieve greatness.As head of scientific/medical writing, you will develop processes for scientific and medical writing from Phase I to market access. You will also lead an international scientific/medical writing team and coach/develop the team members. In addition to your managerial duties, you will assure the timely generation of high-quality regulatory documents required for the clinical development of novel immunotherapeutic agents. You will collaborate closely with (regulatory) project management, clinical operations, and the non-clinical development team. The position will be based at our headquarters in Mainz.
- Lead and develop scientific and medical writing at BioNTech
- Play an integral part in the planning for and preparation of clinical and nonclinical documents in accordance with appropriate national and international guidelines
- Establish and maintain internal processes for medical writing
- Guide the writing and development of team members within the writing group
- Represent scientific/medical writing at key cross-functional teams
- Provide senior oversight of document quality and consistency
- Collaborate with external service providers
What you have to offer.
- 5+ years’ experience as scientific and medical writer in the pharmaceutical/biotech industry, preferably with management experience
- MD or Ph.D. in a relevant life science, ideally with expert knowledge of oncology and immunology
- 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
Benefits for you.
Have we kindled your pioneering spirit?Please send us your application in English outlining your suitability for the role. Friederike Mangelsen will be happy to answer any further questions you may have at + 49 (0) 6131-9084-1291 (Monday-Friday, from 12 p.m. - 6 p.m.).
*BioNTech does not differentiate on the basis of gender, race, religion, color, origin, sexual orientation, disability, age and other protected status as required by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer.
BioNTech - As unique as you.