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eu translations coordinator

  • Scientific
  • Ashford
  • Negotiable
  • Contract
  • Full Time
  • 240286/001
  • 23 May 2018
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Exciting position for a Translations Coordinator has become available. If you have knowledge of Documentum based eDocument management systems (e.g GDMS) file transfer tools such as PACT and document content shells and knowledge of the drug development process then this is the job for you…………………

Job Title: Translations Coordinator

Location: Kent

Job Type: 6 months contract

Salary: £15.91 per hour

Primary Responsibilities

* Works with the Labelling Operations Specialist (LOS) and Above Country strategist to obtain the internally approved EN label, submission type and summary of changes.

* Owns the forecast spreadsheet, actively seeking updates and clarity to provide status update to PCOs; proactively works with the PCOs to provide upcoming translations and timelines.

* Provides draft GDMS links to the PCOs for each country language and lifecycle within the system once HA Approved.

* Ensures that all labelling translation jobs initiated within GDMS have been picked up by the designated Labelling Translations Vendor and that the resulting translations are delivered per the agreed SLA timeframes.

* Monitors internal tracking systems to ensure that the status of every labelling translation is visible and overseen through to completion and entered into the correct location in the Pfizer document management system.

* Suggests/advises the team which label translations should occur 'at risk', liaises with the Translations vendor to progress the translations accordingly; Trouble shoots vendor issues as required.

* If required, performs QRD format QC check in accordance with EMA guidelines and spot checks vendor QRD formatting.

* Work with other translation coordinators to ensure all product activity adequately covered.

* Takes responsibilities for the Translations mailbox, maintenance and archiving.

* Provide WSR with required files and links for key submission days (Day 5 &20).

* Suggest process and training improvements for translations either via experience or feedback from stakeholders and revises necessary documents as required.

* Ensures CHMP opinion is communicated to PCOs and the Translation Vendor so that the appropriate actions are taken, and deadlines are re-confirmed.

* Proactively manages Vendors as due dates get nearer so that potential delays can be eliminated.

* Understands PDF & Bookmarking requirements - carrying out tasks if required.

* Proactively uses Eudralink Account to monitor local HA responses and co-ordinate actions and issue resolution with PCOs.

* Collates and completes the EMA QRD forms for WRS to review and use for submission.

* Builds expertise and knowledge in CP and MRP translations to become SMEs for stakeholders.

* Actively maintains and updates knowledge of EMA QRD label format requirements.

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