Dossier Manager

CK GROUP; Stone Cross; On-site; Full time

Job description

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. is 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 Industry.
• Strong knowledge of the drug development process, regulatory sciences, and submission management & publishing.
• Proven aptitude in project management and logistics.
• Ability to work on multiple highly complex projects simultaneously.

Company:
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:
This role is based at our clients site in Sandwich.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 124 719 in all correspondence.

Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.