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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Junior Non Clinical Report Specialist 

 

Pharma R&D Preclinical Development GLP Archive and Reporting Cluster

 

The Report Management team in Preclinical Development mainly supports the technical creation, preparation, and processing of non-clinical toxicology and DMPK reports for authority submissions (internal reports as well as external CRO reports). The team ensures eCTD readiness and therefore compliance with regulatory requirements.

The team is supported by a cross-functional group of colleagues within PCD (ED Documentation Group) who also prepare and maintain non-clinical reports in the system.

The person(s) we are looking for need excellent technical skills in Document Management systems and they have to be good team players.

The workload varies in terms of time and quantity, so a certain degree of flexibility is required.

 

Tasks and Responsibilities:

  • Technical preparation of non-clinical reports for eCTD readiness in Document Management (DMS) System BRAVE
  • Processing and compilation of regulatory submission relevant non-clinical reports in DMS BRAVE

Technical skills:

  • Excellent skills in Microsoft Office Word
  • Excellent skills in Adobe Acrobat Pro DC
  • Familiar with the Document Management System (DMS) BRAVE
  • Affinity to technical tools to e.g. learn more functionalities within the DMS
  • Experience with compilation tools (docuBridge, currently still via Citrix)
  • Very good verbal and written English skills
  • In addition: very good verbal and written German skills would be very helpful for onboarding and for communication with ED Documentation Group members
  • Basic knowledge of and experience with Good Laboratory Practice (GLP)

Other skills:

  • Ability to work in a structured manner according to regulations
  • Independent allocation and completion of workload and organization of daily work
  • Ability to independently solve problems in the event of deviations from the standard process (scenarios are compiled in manuals and evaluated using these)

Social and team skills:

  • Ability to work in a team (collaboration within the ED documentation group)
  • Open and friendly interaction with customers
   
YOUR APPLICATION  
   

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer. 
 
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
 

  

 

Location:

Spain : Cataluña : Barcelona  

 

Division:

Enabling Functions 

 

Reference Code:

831115 


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