Scientific & Procedure Advisor – £37,456-£42,084 p.a. + benefits

London

Job Summary We are currently looking for a Scientific &​ Procedure Advisor to join our Authorisation Lifecycle Function within the Health Quality and Access group.

We have two full-time opportunities, one on a permanent basis and one fixed term contract for a period of 12 months. Internal move, temporary promotion, loans will be considered. 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.

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 authorisation and market access, as well as ensuring compliance with regulations and standards.

The Authorisation Lifecycle function is an enabler, central to delivery of the frontline HQA group. It includes data assurance and quality, high-volume certification work and coordination and support to the frontline functions. It also includes some more complex activity that supports across the product lifecycle such as medicines and medical devices, borderline, patient information and medicines advertising.

Job Description What’s the role? The post holder is required to assess the accuracy of documents and data held on internal databases to support applications following initial assessment, and also assess some variations and abridged simple applications. The post holder will also communicate with and provide advice to internal and external stakeholders, as required.

Key Responsibilities:

• Perform compliance assessments (checking of product information on MHRA systems) for new marketing authorisation applications.
• Assessment of Regulation 56 (formerly Article 10c) marketing authorisation applications
• Assessment of variations subsequent to the grant of a marketing authorisation
• Work collaboratively to drive continuous improvement within the group

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

• A degree in chemistry, pharmacology or other scientific discipline, or relevant experience
• A working knowledge of the documentation required to support a marketing authorisation application in the UK and Europe
• Be able to communicate effectively with internal and external stakeholders, with a proven ability to clearly explain information verbally and by written communication
• Good personal work organisation, attention to detail and analytical or assessment skills, including the ability to make sound decisions while working to tight deadlines
• A proactive approach to problem solving in a multidisciplinary, target-orientated team.

What’s the role? The post holder is required to assess the accuracy of documents and data held on internal databases to support applications following initial assessment, and also assess some variations and abridged simple applications. The post holder will also communicate with and provide advice to internal and external stakeholders, as required.

Our Successful Candidate Will Have The Following:

• A degree in chemistry, pharmacology or other scientific discipline, or relevant experience
• A working knowledge of the documentation required to support a marketing authorisation application in the UK and Europe
• Be able to communicate effectively with internal and external stakeholders, with a proven ability to clearly explain information verbally and by written communication
• Good personal work organisation, attention to detail and analytical or assessment skills, including the ability to make sound decisions while working to tight deadlines
• A proactive approach to problem solving in a multidisciplinary, target-orientated team.

Person specification

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

• Working Together - A proactive approach to problem solving in a multidisciplinary, target-orientated team. (A, I)
• Communicating &​ Influencing - Be able to communicate effectively with internal and external stakeholders, with a proven ability to clearly explain information verbally and by written communication (A, I)
• Making Effective Decisions - Good personal work organisation, attention to detail and analytical or assessment skills, including the ability to make sound decisions while working to tight deadlines (A, I)

Experience Criteria:

• A degree in chemistry, pharmacology or other scientific discipline, or relevant experience (A)
• A working knowledge of the documentation required to support a marketing authorisation/PLPI application in the UK and Europe. (A, I)

Technical Criteria:

• Good information management and technology skills including the preparation and/or maintenance of Word and Adobe documents, spreadsheets and reference databases as well as high level of competence in the use of the agency’s custom Sentinel system. (A, I)
• An understanding of the relevant legislation, guidance and procedures used to obtain or change a marketing authorisation (Scientific and Procedure Advisor – MA specialists), or obtain, change (variation) or renew a PLPI authorisation (Scientific and Procedure Advisor – PLPI specialist). (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 Experience Criteria. 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.

**If you require any disability related adjustment