About the job

Job summary

We are currently looking for a Pharmaceutical Assessor to join our Import Notification System assessment team, in 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 4 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 8 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 enhances and improves 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 Group 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.

Job description

What’s the role? 

 

The post holder will work as part of the Import Notification System (INS) assessment team performing safety, and safety in relation to quality, vetoing of notifications of intent to import unlicensed medicines.

The INS is an MHRA function dedicated to the statutory duty of processing and assessing notifications of intent to import unlicensed medicines into the UK.

 

Key responsibilities: 

 

• Assess notifications for importation into the UK of unlicensed medicinal products received under SI 2005/2789 regulation 167 and Schedule 4 against known patient safety or product quality issues affecting unlicensed medicines, to determine if a non‑objection or objection to import should be issued.  Decisions must be made in a timeframe appropriate to the urgency of the issue, and on the information available at that time.
• Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases and relevant archives.
• Work with Department of Health & Social Care Medicine Supply Team and the NHS Commercial Medicines Unit to highlight and manage supply disruptions.
• Work in conjunction with Importers, Manufacturers and Marketing Authorisation Holders to gather sufficient information to make informed decisions regarding supply of unlicensed medicines and to agree proposed courses of action.
• Provide regulatory and scientific advice and guidance to MHRA colleagues across the agency and to external stakeholders to facilitate and enable continuity of supply of medicinal products in the UK.
• Work with Communications and Engagement and Partnerships groups to ensure media handling and press lines are accurate, effective and commensurate to the risk.
• Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.
• On call duty rota commitment

Person specification

Who are we looking for? 

 

Our successful candidate will:

 

• Have experience in the Pharmaceutical Industry, NHS quality assurance or manufacturing roles, or relevant roles within a competent authority, and a thorough working knowledge of Good Manufacturing Practice and regulations underpinning pharmaceutical manufacture and distribution.
• Have demonstrable experience of developing successful relationships with both internal and external stakeholders, with excellent communication skills.
• Hold a degree in a relevant science (e.g. pharmacy, chemistry, pharmacology, medicine).
• Knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture and quality assurance of human medicinal products.
• Be able to work flexibly, with the ability to adapt to changing priorities and take responsibility for achieving a successful outcome

 

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 £56,353, Medicines and Healthcare Products Regulatory Agency contributes £15,215 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

The selection process: 

 

We use the Civil Service Success Profiles to assess our candidates, find out more here. The selection process involves:

 

§  An 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. 

§  A test; further information will be supplied when you reach this stage 

§  Interview, which may 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 experience in the Pharmaceutical Industry, NHS quality assurance or manufacturing roles, or relevant roles within a competent authority, and a thorough working knowledge of Good Manufacturing Practice and regulations underpinning pharmaceutical manufacture and distribution.

 

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.  Please ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description. 

 

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible. 

  

Closing date:  18th December 2023

Interview date: 8th/9th January 2024

 

If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk 

 

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here. 

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5-year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, Mira.Mepa@mhra.gov.uk.  

 

If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk 

 

info@csc.gov.uk 

Civil Service Commission 

Room G/8 

1 Horse Guards Road 

London 

SW1A 2HQ 

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. People working with government assets must complete baseline personnel security standard (opens in new window) checks.

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)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria. The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.