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Scientific and Procedure Advisor
Macedonian Human Resources AssociationScientific & Procedure Advisor for MHRA's Authorisation Lifecycle, assessing documents and advising stakeholders. Hybrid role requiring office attendance and collaboration with internal and external teams.
About the role
Key responsibilities & impact- Assess the accuracy of documents and data held on internal databases to support applications following initial assessment.
- Assess some variations and abridged simple applications.
- Communicate with and provide advice to internal and external stakeholders, as required.
- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Flexible, hybrid way of working with a minimum of 8 days per month working on site.
- Government departments and agencies are working towards implementing a minimum of 60% attendance in office sites.
- Opportunities for internal move, temporary promotion, loans considered.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Document AssessmentData Accuracy VerificationRegulation 56 AssessmentAbridged Application AssessmentProduct Information Checking
Soft Skills
Attention To DetailProblem SolvingPersonal Work OrganisationCollaborationDecision Making