Head of Scientific/Medical Writing
BioNTech · Mainz
Mainz, Germany | full time | Job ID: 11753
About the Role:
Are you ready to lead and inspire a team dedicated to advancing healthcare innovation? As Head of Scientific/Medical Writing at BioNTech, you will play a pivotal role in driving company strategies and standards for regulatory documents, ensuring the timely generation of clinical regulatory documentation essential for developing novel therapies. This position combines leadership (60%) with hands-on scientific/medical writing expertise (40%), offering you the opportunity to shape processes, mentor talent, and contribute directly to groundbreaking submissions that impact patients worldwide.
Your Contribution:
- Lead a cohesive, innovative department composed of four groups, ensuring alignment with business needs while fostering collaboration and flexibility.
- Recruit, mentor, and develop team members while setting objectives, assessing performance, and ensuring compliance with company values and standards.
- Drive strategic guidance for non-standard situations by leveraging extensive knowledge of regulations, guidelines, and company practices.
- Oversee the creation and implementation of tools, SOPs, templates, instructions, and training materials relevant to scientific/medical writing processes.
- Perform complex scientific/medical writing tasks independently for low to high complexity regulatory documents (e.g., CTPs, CSRs, IBs) required for development from discovery through marketing approval.
- Lead teams of writers preparing dossiers for marketing approval while ensuring compliance with trial transparency and data privacy requirements.
A Good Match:
- Advanced degree in science or medicine (M.D., Pharm.D., Ph.D.) with a strong background in immunology and oncology preferred.
- 15 years hands-on experience as a scientific/medical writer drafting complex regulatory documents across multiple indications in the pharmaceutical/biotech industry and as lead medical writer for teams of writers for clinical parts of BLA/MAA dossiers.
- 10 years experience as a line manager with budget/resource/project management responsibilities; prior experience interacting with industry stakeholders and regulatory authorities is advantageous.
- Visionary leadership skills with advanced influencing, negotiation, conflict resolution, mediation, and project management abilities.
- Expert knowledge of role-relevant regulations/guidance (e.g., EU CTR, ICH E3/E6/E9/M4) and advanced proficiency in MS Word; good skills in MS PowerPoint/Excel/MS Teams/DMS systems like Veeva Vault are preferred.
- Native-level English proficiency; German skills are an advantage.
- Strong ability to summarize scientific results clearly and concisely with excellent attention to detail.
Join us at BioNTech as we transform lives through science!
Your Benefits:
It's our priority to support you:
- Your flexibility: flexible hours | vacation account
- Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
- Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
- Your health and lifestyle: Company bike
- Your mobility: Job ticket | Deutschlandticket
- Your life phases: Employer-funded pension | Childcare
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 11753 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed.
* Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application.