DAQ Classifier - £32,617 p.a. + benefits

at  Medicines and Healthcare products Regulatory Agency

JOB SUMMARY

We are currently looking for a DAQ Classifier to join our Data Assurance & Quality Function within the Healthcare Quality and Access group.
This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

JOB DESCRIPTION

The MHRA’s Data Assurance & Quality (DAQ)Unit is responsible for initial data entry of regulatory applications onto the Agency’s computer systems. The unit has around 60 data processing staff and processes over 100,000 items of work per year.
Within the unit the operational delivery function is split into work streams each focussed 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. Data Assurance & Quality (DAQ)Classifiers are expected to work in all areas of the unit in response to fluctuating operational pressures.
Data Assurance & Quality (DAQ)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 or conducting audits. It is a target driven environment where speed is important, and quality and consistency are also vital.
Data Assurance & Quality (DAQ)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. Data Assurance & Quality (DAQ)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

PERSON SPECIFICATION

Our successful candidate will:

• Excellent attention to detail when reviewing complex scientific and regulatory documentation and dealing with databases, to ensure high standards of data quality and accuracy.
• Ability to check own and team performance against outcomes, make improvement suggestions or take corrective action when problems are identified.
• Ability to build relationships and work successfully in a multi-disciplinary team environment.
• Demonstrate knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe
• Excellent verbal and written communication skills with the ability to communicate complex scientific information clearly and accurately to applicants and professional colleagues and the public

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk
Benefits

Alongside your salary of £32,617, Medicines and Healthcare Products Regulatory Agency contributes £9,449 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
• Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP’s Pension Service Centre directly on 0300 123 6666
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join the Civil Service Motoring Association (CSMA)
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

SELECTION PROCESS DETAILS

We use the Civil Service Success Profiles to assess our candidates, find out more here.

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

NATIONALITY REQUIREMENTS

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

KEY RESPONSIBILITIES:

• Validate, process or quality check regulatory submissions and reference supporting documentation for medical product licensing applications.
• Ensure that regulatory guidelines are followed in checking the validity of applications received.
• Liaise with applicants and assessor colleagues to address and resolve validation issues or inadequate documentation.
• Establish a thorough knowledge of regulatory procedures, both National and European, and utilise this knowledge to validate product licence applications.