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Wörwag Pharma located in Böblingen near Stuttgart is a mid-sized and internationally operating 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 in our headquarter in Böblingen (near Stuttgart) because we are looking for you as a

  

Manager Medical Regulatory Writing (m/f/x) 

 

Within the Global Medical Department and the Global Regulatory Medical Writing team.

 

 

 

Tasks & Responsibilities: 

 

  • 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 
  • Creation, review and evaluation of information texts for 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 and coordination of 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
  • Support of the Team Lead Medical Regulatory Writing

 

Requirements:

 

  • 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:

 

  • A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
  • Varied challenges, as well as exciting projects with a strong team spirit
  • Compensation in line with the market and your performance, as well as additional benefits which can be used flexibly according to your needs, e.g.,   
    • Subsidy for direct insurance
    • Individual compensation options for days off, pension provisions or payout
    • Bonago vouchers for special occasions
    • Support for your general well-being and/or work-life balance
    • Health-promoting measures such as discounted conditions on over-the-counter (OTC) pharmacy products or health days
  • Flexible trust-based working hours, as well as the possibility of mobile working
  • Central company headquarters with good public transport connections, as well as mobility allowances
  • A wide range of opportunities for personal and professional development
  • Regular employee events