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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 e CTD 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 e CTD 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 (docu Bridge, 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

Location:
Spain : Cataluña : Barcelona

Division:
Enabling Functions

Reference Code:
831115