CK Group are recruiting for a Dossier Manager, to join a company in the Pharmaceutical industry, at their site based in Sandwich, on a contract basis for 12 months.

PLEASE NOTE:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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• Monitoring document receipts, following up with contributors and translations management (where applicable) for assigned submissions.
• Monitor and verify Suspected Unexpected Serious Adverse Reaction (SUSAR) arising from clinical trial, report to Regulatory Authority within agreed timeline to protect patient’s safety.
• Adhere to FDA regulations.
• Successfully interface with multiple cultures and functions from within the company, to recognize, and exploit opportunities to use scale, cloning and repurposing dossiers for worldwide markets where feasible.
• Engages Submission managers & Publishing leaders, business suppliers and other key regional representatives as appropriate, to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.
• Provides guidance to and leads moderately complex submission and process improvement projects, making decisions independently.