Company: Regulatory Professionals
Closing Date: 20 Nov 16
Salary (£): On Application
Labelling Support Consultant Duration: 3 month contract ( Extreme likelihood of Renewal) Location: Buckinghamshire Would you like the flexibility of a short term contract that will still employ you beyond 2016?
Labelling Support Consultant
Duration: 3 month contract ( Extreme likelihood of Renewal )
Rate: Very Competitive
Would you like the flexibility of a short term contract that will still employ you beyond 2016?
Are you looking to work for a top 5 pharmaceutical?
Do you have experience of working with CCDS?
If you've answered yes, then this role might be just for you.
Regulatory Professionals are currently seeking a Labelling Support Consultant to operate on a freelance basis for one of the most recognised pharmaceutical innovators in the industry.
The role is part of the late stages of a major Labelling compliance program for an established product portfolio.
As a Labelling Support Consultant, the professional will be involved in checking the accuracy of completed labelling discrepancy reasoning reports and compilation and summarisation of findings to facilitate remediation activities.
Responsibilities will revolve around:
- Reviewing reports with discrepancies and their justifications for completeness and accuracy in accordance with the RLC process.
- Compiling and summarizing unjustified discrepancies to facilitate remediation activities.
Optimal candidate will have a background that will entail:
-At least 4 years' experience in the pharmaceutical industry or health authority, with at least 3 years' experience in regulatory affairs with experience associated with product labelling.
-Product labelling experience should include authoring text for inclusion in product labelling (CCDS, EUPI, USPI).
-Experience in Liaising with subject matter experts and regulatory professionals.
-The candidate is expected to have excellent project management, verbal and written communication skills.
-Minimum of Bachelor's degree in a scientific discipline or equivalent. An advanced degree would be advantageous.
This is a fantastic opportunity that will allow the right candidate to gain exposure with one of the world's leading pharmaceuticals innovators. Opportunity to work on a short term contract with this client is not a common occurrence, if you fit the requirements and would like to be submitted please don't delay and get in touch as soon as you can.
Keywords: Regulatory Affairs Project Manager, Regulatory Affairs Officer, Regulatory Affairs Labelling, Regulatory Affairs Labeling, Labeling, Labelling, CCDS, SmPC, USPI, EUPI, PILs, PSUR, Buckinghamshire, Berkshire, Hertfordshire, Middlesex, High Wycombe, Hayes, Slough , Maidenhead.
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