Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
About the Role
The Scientific & Procedure Advisor will assess the accuracy of documents and data on internal databases to support applications, assess variations and simple applications, and communicate with and provide advice to internal and external stakeholders.
Responsibilities
- Perform compliance assessments for new marketing authorisation applications.
- Assess Regulation 56 marketing authorisation applications.
- Assess variations subsequent to the grant of a marketing authorisation.
- Work collaboratively to drive continuous improvement within the group.
Requirements
- A degree in chemistry, pharmacology or other scientific discipline, or relevant experience.
- Working knowledge of the documentation required to support a marketing authorisation application in the UK and Europe.
- Ability 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.
- Good information management and technology skills including the preparation and/or maintenance of Word and Adobe documents, spreadsheets and reference databases.
- High level of competence in the use of the agency’s custom Sentinel system.
- Understanding of the relevant legislation, guidance and procedures used to obtain or change a marketing authorisation or PLPI authorisation.
Skills
- Chemistry
- Pharmacology
- Scientific discipline
- Documentation for marketing authorisation applications
- Verbal communication
- Written communication
- Work organisation
- Attention to detail
- Analytical skills
- Assessment skills
- Decision making
- Problem solving
- Information management
- Technology skills
- Word document preparation/maintenance
- Adobe document preparation/maintenance
- Spreadsheet preparation/maintenance
- Reference database preparation/maintenance
- Sentinel system usage
- Understanding of relevant legislation, guidance, and procedures for marketing authorisations
Location
- 10 South Colonnade, Canary Wharf London, E14 4PU
- UK
Work Type
- Full-time
- Permanent
- Fixed term contract (12 months)
- Hybrid
Experience Level
- Relevant experience
Education Level
- Degree in chemistry, pharmacology or other scientific discipline
About the Company
- 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 agency is made up of c.1300 staff working across two main centres and peripatetically across the UK and abroad.
- The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.
- 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.
- 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.
Equal Opportunity
- Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules.
- 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.
- Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance.
- Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD).
- 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.
- Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms.
- Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater.
- The individual will not retain any allowances paid by the former department/Agency, unless there are special circumstances, such as a reserved right to those allowances on transfer.
- Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements.
- 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.