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.
Salary:
PAYE £16.76 - £19.75 per hour or UMB £18.78 - £22.13 per hour.
Dossier Manager Role:
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.
Your Background:
B.S./B.Scs. in Pharmacy, Life Sciences, Business or Information Technology, or equivalent relevant professional experience will be considered.
Relevant experience in electronic submissions build and publish within the Pharmaceutical Indust...