Loading...
Share this Job

WÖRWAG Pharma located in Böblingen near Stuttgart is a mid-sized, international pharmaceutical company. As a family-owned company we develop and distribute biofactors and generics. We are represented in more than 35 countries with about 1000 employees.


Become a part of our team because we are looking for you as a

 

Medical Writing Manager (m/f/x) Regulatory Affairs 

Your duties:

  • Independent preparation of non-clinical and clinical documents and parts of eCTD dossiers which are relevant for marketing authorisations in accordance with regulatory and internal specifications for European and global marketing authorisation
  • Review and evaluation of the accuracy, consistency and plausibility of externally produced clinical and non-clinical documents which are relevant for marketing authorisation 
  • Acquisition, organisation, monitoring and management of external service providers
  • Creation, review and evaluation of information texts for generics, medicinal products and food supplements
  • Contact person for regulatory authorities and internal customers relating to non-clinical and clinical questions on dossier parts
  • Replying to Deficiency Letters with regard to non-clinical and clinical issues
  • Participation in team meetings at cross-departmental and cross-divisional interfaces
  • Dealing with document management systems and literature databases
  • Ensuring compliance with internal deadlines and quality specifications for the above-mentioned processes
  • Improving existing processes and internal policies

 

Your profile:

  • Successfully completed scientific studies or a comparable scientific education
  • Licence to practise as a human or veterinary doctor or pharmacist is an advantage
  • Several years of relevant professional experience in the fields of Medical Affairs (Medical Writing) and/or Regulatory Affairs/Regulatory Medical Writing
  • Pronounced ability to produce written documents of high quality and check the technical content of externally produced documents
  • You are used to working in a team, but also independently, accurately and in a goal-oriented manner.
  • Analytical and structured way of thinking and working
  • Very good communication and assertiveness skills, as well as a very good command of English

 

 

What we offer:

  • We offer you a challenging and varied scope of tasks in a dynamic team of a successful, mid-sized  pharmaceutical company
  • We offer you exciting projects in an international work environment, with the opportunity to quickly take responsibility and to share your experiences and knowledge
  • In addition to a performance-based salary you receive a comprehensive offer of additional benefits, for example including an occupational pension provision, workplace health promotions, a job ticket as well as diverse training offers

 

We are looking forward to receiving your application!