Senior DAQ Advisor - £37,456 - £42,084 p.a. + benefits

London

Job Summary We are currently looking for a Senior DAQ Advisor to join our DAQ Variations Function within the Health 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.

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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

Who are we? The Medicines and Healthcare 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 objective of the Healthcare Quality and Access portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards.

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. The Senior Classifier will support the operational management of this area which can be complex as the applications are of various types, their volumes fluctuate often unpredictably from week to week and there are many different processing targets.

Job Description What’s the role? Using their highly developed specialist knowledge, Senior DAQ Advisors have an important role in supporting their colleague’s development through mentoring and training whilst helping to ensure that performance and quality standards are achieved. Senior DAQ Advisors also provide day‐to‐day support for Delivery Leads in the Unit. All Senior DAQ Advisors will have recognised expertise in the Agency’s information management and regulatory validation requirements processed by Data Assurance &​ Quality (DAQ) i.e. Variations, New MAA and Clinical trials.

It is a target driven environment where speed is important, and quality and consistency are also vital. Senior DAQ Advisors also need to be able to interact confidently and clearly with professional colleagues and with external applicants.

Key Responsibilities:

• Working closely with the Delivery Lead to ensure service level and legislative targets are met.
• Provide expertise with work procedures and processes across all work areas and specialist knowledge with some complex procedures such as variations, new MAA and eSubmission formats and requirements.
• Ensure that regulatory guidelines are followed in checking the validity of applications received.
• Supporting and assisting DAQ Classifiers in the preparation of high-quality case folders ready for professional assessment and ensuring these are allocated to the relevant Agency function within required timescales and targets.
• Mentor and train classifiers within the unit to help ensure performance and quality standards are met.

Who are we looking for? Our Successful Candidate Will Demonstrate The Following:

• Changing and Improving
• Managing a Quality Service
• Graduate with Life Sciences degree or other relevant degree
• Proven organisational skills and ability to work to deadlines
• Knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe.

What’s the role? Using their highly developed specialist knowledge, Senior DAQ Advisors have an important role in supporting their colleague’s development through mentoring and training whilst helping to ensure that performance and quality standards are achieved. Senior DAQ Advisors also provide day‐to‐day support for Delivery Leads in the Unit. All Senior DAQ Advisors will have recognised expertise in the Agency’s information management and regulatory validation requirements processed by Data Assurance &​ Quality (DAQ) i.e. Variations, New MAA and Clinical trials.

It is a target driven environment where speed is important, and quality and consistency are also vital. Senior DAQ Advisors also need to be able to interact confidently and clearly with professional colleagues and with external applicants.

Our Successful Candidate Will Demonstrate The Following:

• Changing and Improving
• Managing a Quality Service
• Graduate with Life Sciences degree or other relevant degree
• Proven organisational skills and ability to work to deadlines
• Knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe.

Person specification

Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria:

• Managing a Quality Service (A/I)
• Delivering at Pace (A/I)
• Developing Self and Others (A/I)
• Working Together (A/I)
• Changing and Improving (A/I)

Experience Criteria:

• Proven organisational skills and ability to work to deadlines in a pressurised, target driven environment, whilst maintaining high standards of quality. (A/I)
• Demonstrate knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe. (A/I)

Technical Criteria:

• Graduate with Life Sciences degree or other relevant degree with experience of the information management or extensive experience of the information management of regulatory submissions. (A/I)
• Demonstrates excellent verbal and written communication skills with proven ability to communicate complex information, which is often scientific in nature, confidently and diplomatically across the range of external and internal stakeholders. (A/I)

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 Alongside your salary of £37,456, Medicines and Healthcare Products Regulatory Agency contributes £10,851 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• 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 Motoring , Boundless by CSMA
• Variety of staff and Civil Service clubs
• On-going learning and development

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.

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.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of: Developing Self and Others 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 o