Executive Officer - Canary Wharf, London
Salary: £13.22 ph.
Location: Canary Wharf
Must Have: Bio-medical or knowledge with medical terminology.
If you`re looking to expand your skills in a professional, credible environment, we would like to offer you the perfect opportunity.
The Medicines and Health care products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.
The agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad. This role is home based with occasional travel to London offices expected, on these occasions, travel and accommodation will be paid.
A centre of the agency the MHRA consists of Vigilance and Risk Management of Medicines (VRMM), Licensing, Devices and Inspection, Enforcement & Standards (IE&S). The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.
Purpose of Role:
Within the Transformation Division, the Information Processing Unit (IPU) is responsible for ensuring that regulatory applications relating to Marketing Authorisations and Clinical Trial Authorisations are entered and validated on the Agency's Sentinel database system. It is a fast-paced target driven environment as the team plays a vital role in ensuring the Agency meets its legislative and regulatory targets and that its decisions are supported by high quality data.
Within the unit the operational delivery function is split into work streams each focused on specific processes. There is a strong focus on flexible, proactive operational and personnel performance management to ensure delivery against service level and legislative targets. Information Processing Classifiers are expected to work in all areas of the unit in response to fluctuating operational pressures
Information Processing Classifiers have an important role in using their specialist knowledge to interpret and validate regulatory submission received from pharmaceutical industry applicants. In carrying out this role, they will establish a good working knowledge of medicines legislation, regulations and guidelines as applied to their area and apply these requirements in a consistent manner. In some areas, they will make the final decision on the validity of an application; in others they will be preparing a high-quality case folder for subsequent professional assessment. It is a target driven environment where speed is important, and quality and consistency are also vital. Information Processing Classifiers also need to be able to interact confidently and clearly with professional colleagues and with external applicants.
The post offers the opportunity to work within a high performing and motivated team in a high-profile area of work and to play a role in achieving the wider Agency targets. Information Processing Classifiers work within a team that operates a system of matrix working in the various areas of product licensing to allow the flexibility to ensure that high level targets are met whilst delivering high quality work.
- Working closely with the Delivery Manager to ensure service level and legislative targets are met.
- Ensure that regulatory guidelines are followed in checking the validity of applications received.
- Prepare high quality case folders ready for professional assessment and ensuring these are allocated to the relevant Agency function within required timescales and targets.
- Validate and process regulatory submissions and reference supporting documentation for medical product licensing applications.
- Apply regulatory guidelines to ensure check the validity of the applications received.
- Liaise with applicants and assessor colleagues to address and resolve validation issues or inadequate documentation.
Typical qualifications and experience required:
- Five GCSEs at Grade C or above or equivalent (including English Language or equivalent)
- NVQ Business Administration Level 2 (or suitable clerical experience)
- Administrative experience with a good knowledge of and experience in using Microsoft Office
- Good communication skills, both oral and written
Once shortlisted a Brook Street consultant will be in touch.