Scientific Assessor - 37,456-42,084 p.a. + benefits

We are currently looking for a Scientific Assessor to join our Established Medicines (Parallel imports Team) within the Healthcare Quality & 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 Population Health function delivers a risk appropriate critical appraisal of quality, safety and efficacy of healthcare products that are critical to the NHS and wider population, determining whether a products benefits outweighs the risks. This includes special populations such as paediatrics and our work on self-medication and unlicensed imports, as well as our high-volume work on generic medicines, other complimentary products as well as parallel import medicines. This enables access while ultimately reducing costs to the healthcare system and delivering positive patient benefits as a result.

The Parallel Import Unit is responsible for all licensing activities relating to the parallel importation of medicinal products from within the European Union. Scientific Assessors evaluate and approve applications for new Parallel Import Licenses as well as variations and update patient information leaflets, ensuring compliance with regulatory requirements and continues safe use of medicines.

Key Responsibilities:

• Assess initial applications of Parallel Import Licences including of new source and existing source applications by confirming the therapeutic equivalence of the UK and imported product and evaluating of proposed labels and patient information leaflets.
• Assess variation applications including updates to patient information leaflets in accordance with relevant regulatory requirements.
• Assess of Renewal applications in accordance with relevant regulatory requirements.
• Assess Patient Information leaflets for safety-related changes arising from pharmacovigilance activities.
• Maintain awareness of safety updates and ensure relevant information is included in patient leaflets.
• Analytically interpret available information on the imported medicinal product to determine their acceptability for licencing.
• Preparation of assessment reports for applications, ensuring all points comply with parallel import scheme guidelines.
• Preparation and updating of master assessment reports as required.
• Communicate with internal specialists, external stakeholders, including European regulatory authorities, as required to support assessment.
• Maintain MHRA information systems with complete and auditable records of the assessment process.
• Provide training, guidance and ongoing support for new assessors within the team.
• Meet agreed performance, quality and assessment targets.

Essential Criteria:

• Demonstrable experience in the analysis and interpretation of complex information, maintaining a high level of accuracy and attention to detail when assessing and evaluating evidence.
• Experience of and proven ability to work to tight deadlines and consistently meet targets