Senior Scientific Lead - £42,869 p.a. + benefits

at  Medicines and Healthcare products Regulatory Agency

JOB SUMMARY

We are currently looking for a Senior Scientific Lead to join our Authorisation Lifecycle function within 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 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.

JOB DESCRIPTION

The postholder will be part of a small team delivering scientific work, including the preparation of Public Assessment reports (PARs) for new marketing authorisations and following complex variations. The post holder will also handle responses to Freedom of Information (FOI) requests for Health Quality and Access Division, assess and grant appropriate variations, and contribute to development of policy and processes in connection with the role.

PERSON SPECIFICATION

• A graduate in an appropriate scientific discipline, e.g. medicinal chemistry, pharmacy, pharmacology, or other biological and pharmaceutical sciences.
• Experience of medical or scientific writing/editing.
• Highly organised, with a proven ability to work to tight deadlines and under pressure.
• Excellent IT skills, including being able to use a variety of document publishing tools, and use of MHRA’s bespoke licensing systems.
• Knowledge of the relevant legislation and regulatory requirements applicable to the authorisation of medicinal product.
  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 £42,869, Medicines and Healthcare Products Regulatory Agency contributes £12,419 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• 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 the Civil Service Motoring Association (CSMA)
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

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.

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.

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)

KEY RESPONSIBILITIES:

• To be able to work collaboratively and effectively manage preparation of Public Assessment Reports (PARs), assessment of appropriate variations and Freedom of Information requests (FOIs). To be able to triage, prioritise and organise the work– including collaboration with internal and external stakeholders – to ensure work is delivered to a high quality and on time. This includes the creation and maintenance of policies and procedures for this area of work.
• To prepare documents to a high quality and within high-level targets, including preparing drafts and updating with comments from internal and external stakeholders.
• To provide clear, reliable, timely advice, support and information in response to enquiries from internal and external stakeholders concerning PARs, appropriate variations and FOIs.
• To maintain MHRA information management systems, including Sentinel case folders, group mailboxes, Sharepoint, Fusion and Outlook.