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

We are currently looking for a Scientific & Procedure Advisor to join our Authorisation Lifecycle Function within the Health Quality and Accessgroup.

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.

Whats 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.

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 agencys 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!

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