Global Regulatory Affairs Publishing Specialist

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12137en
  1. Contract
  2. English
  3. Associate
  4. Research & Development
  5. Bern
  6. Healthcare & Life Sciences
  7. Regulatory Affairs, Publishing, eCTD Lifecycle, eCTD Dossier, eDMS
For our client, one of the leading Healthcare & Life Sciences companies based in the Bern area, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Regulatory Affairs Publishing Specialist.

Duration: 6 month contract

Global Regulatory Affairs Publishing Specialist

Your Mission:
Support the Publishing Group:
- Publishing submission packages with Insight Publisher
- Validation of Published Output (Lorenz Validator)
- Setting of external and internal Hyperlinks using PDF Toolbox
- Performing QA of Hyperlinks
- MS Word template adjustments
- Re-format word documents to apply a header and footer in Documentum

Your Profile:
- University degree or relevant work experience of minimum 3 years
- Previous experience in a similar role
- Experience with the structure and content of an eCTD Dossier to ease the Hyperlinking Process
- Experience with an eCTD Lifecycle
- Experience with Insight Publisher, PDF Toolbox, Validation Tools is an advantage
- Proficient knowledge of MS Word, like Styles and their modifications and applications, Header/Footer tools
- Liquent SmartDesk is optional but desired
- Template design and implementation in MS Word
- Experience with eDMS (like Documentum or D2)
- Fluency in English

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