Associate Director* Scientific / Medical Writing

  • Mainz
  • Work experience
  • Research, development, teaching
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director Scientific / Medical Writing

As Associate Director* Scientific / Medical Writing, you will ensure the timely generation of high-quality regulatory documents required for the development of novel immunotherapeutic agents from discovery up until marketing approval, and beyond. As part of an international scientific/medical writing team, you will be expected to proactively support a range of experts in research, non-clinical, and clinical, and medical affairs working on innovative products for a wide range of oncology indications and infectious diseases.

This position offers a unique opportunity for you to work on a wide range of documents required during the discovery phase up until post-approval product lifecycle management phase, as well as on publications of scientific and clinical study information for “your” projects.

Your main responsibilities will be:
  • Write, edit, and format a wide range of scientific, regulatory documents (quality, non-clinical, clinical, pharmacovigilance, and labeling) according to standard procedures
  • Write/edit publications, coordinate the publication storyline definition, writing, review, and approval process, and support the submission and post-submission updating processes
  • Check and (if required) revise documents with regard to content, completeness, consistency, and standards compliance
  • Manage the generation of packages of documents required for regulatory dossiers, including the coordination and mentoring of teams of scientific/medical writing staff and/or vendor staff
  • Proactively contribute writing expertise in project teams for optimal data presentation, for document content options/requirements, and for process options and planning
  • Provide training and guidance on good writing practices, the structure/format requirements for regulatory documents/dossiers, good publications practices, and other role-relevant topics

What you have to offer.

  • A relevant life science university degree, ideally M.D. or Pharm. D. or Ph.D.
  • Ideally, at least 5 years of experience as writer in the pharmaceutical or biotech industry supporting the development of therapeutic agents for oncology and/or infectious disease indications
  • Ability to interpret and summarize complex data in a clear, logical, and concise manner
  • A proactive ‘can do’ attitude with the ability to work according to tight timelines and to prioritize workload, whilst concentrating on delivery and adding value
  • Excellent personal organizational, time management skills, and interpersonal skills
  • Exceptional attention to detail
  • Expert skills in MS Office applications (Word, PowerPoint, Excel), ideally also knowledge of applications for graphics generation/editing, editorial checks, and reference management, as well as document management systems
  • Native-level written and spoken English; German skills would be advantageous

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, Johanna Diehl will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon).

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de