Electronic Document Management Specialist in Essen

Our client is a leading Pharmaceutical company and currently have an opening for an Electronic Document Management Specialist on a year long contract.

As the successful candidate you will be responsible for supporting Clinical Document Management assigned activities that require departmental document deliverables to be in submission ready format, in order to support Global Regulatory Agency requirements. Assists with collation of documentation required for internal and external audits, including regulatory agency inspections

- Assist with the preparation, coordination and importing of Clinical Document Management deliverables. (eg, protocol, list of investigators, and list of Institutional Review Boards/Ethic Committees).
- Supports CDM in ensuring adherence to defined document naming standards across all document groups.
- Ensure Shire submission ready standards are applied to system generated, and directly imported, Adobe PDF renditions/documents:
- Apply internal Bookmarks and Hyperlinks as necessary.
- Ensure all clinical documents are legible and 'clean” (e.g. no hole-punch marks, black marks, etc.)
- Perform quality control (QC) of published clinical documents.
- May assist with ensuring electronic case report forms are delivered and imported according to predefined standards and quality control.
- Creation and maintenance of tracking systems associated with electronic clinical documents
- May provide selected document management support to CDOB functions as requested by Manager or designee

- Experience using Documentum ideally including FirstDoc
- Good working knowledge of Microsoft Word and Adobe Acrobat is essential
- General experience with various aspects of Clinical trials and Regulatory submissions, as well as knowledge of Document Management best practices
- Bachelor's degree or equivalent preferred

For further details please call Liadan on +44 (0)20 7922 7127 for a confidential discussion.

This position, Electronic Document Management Specialist in Essen, was posted on March 23, 2011. The job is located in Essen. Since this job has been published, it has been viewed 27 times.