DAQ Classifier - 34,183 p.a. + benefits

We are currently looking for a DAQ Classifier to join our Data Assurance and Quality Functionwithin the Healthcare Quality and Accessgroup.

This is a full-time opportunity, on a permanent basis. Please be aware that this role can only be worked in the UK and not overseas.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.

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.

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.

Whats the role?

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. 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 applicant.

Key responsibilities:

• Support the delivery of three core activities; to cover activities required for DAQ unit to function

• Take ownership and responsibility of own training and development activities

• Fully comply with SOPs and Unit guides in completion of daily activities, highlighting any issues or concerns to Senior Classifier/Delivery Manager as they arise.

• Work with DAQ operational managers in identifying process issues and solutions.

Who are we looking for?

Our successful candidate will have the following:

• Proven organisational skills and a demonstrable track record working to deadlines in a pressurised, target driven environment, whilst maintaining high standards of quality

• Demonstrate knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe.

• Relevant experience reviewing complex scientific and regulatory documentation and dealing with databases, to ensure high standards of data quality and accuracy

• Demonstrate experience of communicating complex medical or regulatory information clearly and accurately to applicants and professional colleagues.

• Relevant Life Sciences Degree or significant equivalent experience in a related area.

Behaviour Criteria:

• Changing and Improving (A, I)

• Making Effective Decisions (A, I)

• Managing a Quality Service (A, I)

• Delivering at Pace (A, I)

• Working Together (I)

Experience Criteria:

• Proven organisational skills and a demonstrable track record working 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)

• Relevant experience reviewing complex scientific and regulatory documentation and dealing with databases, to ensure high standards of data quality and accuracy (A, I)

Technical Criteria:

• Demonstrate experience of communicating complex medical or regulatory information clearly and accurately to applicants and professional colleagues. (A, I)

• Demonstrate knowledge and interpretation of the regulatory procedures surrounding the licensing of medicinal products in the UK and Europe. (A, I)

• Relevant Life Sciences Degree or significant equivalent experience in a related area (A, I)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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