Regulatory Document Specialist

Role: Regulatory Affairs Document Specialist
Duration: 12 months
Location: Sandwich, Kent
Rate: £20 - £25p/h

This leading global pharmaceutical organisation urgently require a regulatory affairs document specialist to join their team for a 12 month interim basis.

The candidates main responsibilities will involve:

- Generate safety data tables for submission to worldwide regulatory agencies for IBs.
- Maintain and develop knowledge of PFAST functionality so that outputs provided to IB Authors are informative and efficiently produced, as well as meeting all regulatory and project requirements.
- Prepare IBs by compiling distinct sections into a cohesive document fit for submission purpose.
- Prepares deliverables in accordance with SOPs, regulatory guidance and internal job aides.
- Closely monitors project timelines associated with specified documents and tables and ensures delivery of necessary contributions according to timelines.
- Ensures clear communication of deliverable purpose and requirements to customer groups.
- Facilitates deliverables through established workflow, intervening when necessary to ensure the successful preparation of high quality, fit for purpose, timely documents.
- Performs QC reviews according to relevant SOPs and job aides

The ideal candidate should have the following experiece:

- Relevant experience of working in a document compilation and publication environment.
- Knowledge of IT systems for generating graphical and tabular data presentations.
- Experience in Pharmaceutical Industry, healthcare or related field required.
- Experience with regulatory and safety guidelines and familiarity with medical terminology preferred.
- Experience working with databases and strong written and oral skills required

My client are looking to have interviews arranged for late next week so if this role is of interest and you would like to discuss it further please contact Peter Duvall at Real Pharma for more details.To find out more about Real please visit www.realstaffing.com