Manager Global Regulatory Affairs CMC Authoring Document Coordinator

Open for hire at one of the following locations –  Mainz Goldgrube. - Job ID: 7578 

 

Join our team of pioneers!

As a part of our team of more than 5.000 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.


 

Manager Global Regulatory Affairs CMC Authoring Document Coordinator 

 

You will format/edit/manage global quality regulatory documents for assigned project(s) in different stages of development, including pre-clinical, Ph I, Ph II, Ph III, initial registration and post-approval stages as well as facilitate optimization of authoring processes to shorten authoring times.

 

Tasks:

 

  • Format/edit global quality regulatory documentation for assigned project(s) in a timely manner and according to the relevant procedures. Ensure that the documentation is ready for publishing
  • Support application of platform approaches to preparation of quality regulatory documentation used in development, registration and post-approval stages
  • Support alignment of structure of quality regulatory documentation across company platforms
  • Support management of quality regulatory documentation in multiple systems, including BioNTech's regulatory information and document management system
  • Liaise with relevant stakeholders to facilitate preparation of quality regulatory documentation of the highest quality and strive to optimize/simplify the authoring processes and shorten the authoring times

 

Requirements:

 

  • Degree in life sciences, computer science, engineering or equivalent
  • 3+ years hands-on experience in editing/formatting/managing complex scientific and/or regulatory documents in pharmaceutical/medical device/health care industry or a research setting
  • Passion for organizing document content to achieve excellent clarity and visual attractiveness of presented information
  • Solid knowledge of document management system(s), procedures and standards
  • Advanced user of MS Office applications, Adobe Acrobat Pro or equivalent software used for creating/editing documents
  • Organizational talent, analytical and conceptual skills as well as excellent communication skills in English (written and spoken)


 

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz GoldgrubeApply now for your preferred job and location through our careers site.


*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!