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Regulatory Affairs Officer / Co-ordinator - Oncology

Regulatory Affairs Officer / Co-ordinator - Oncology
Location: Bracknell
Rate: £150.00 - £180.00 Per Day

Working for a global leader in pharmaceutical development, you will be passionate about ensuring Good Clinical Practice is followed whilst playing an integral role within the medical affairs department.


-Implement and co-ordinate investigator study (IIS) activities run in the UK and Ireland, from study proposal through to study end including tracking payments and ensuring the appropriate processes have been followed to ensure IISs are delivered according to departmental and company standards. Escalate to MA team members as required.
-Implement and co-ordinate individual patient supply (IPS) programmes for the various therapy areas within the Medical Affairs Department, as required. This includes but not limited to tracking of patient supplies, document control, site liaison and programme review and update implementation.
-Provide administrative support to a department which includes initiating, composing, typing and editing correspondence, reports, taking and transcribing minutes, compiling presentations and producing reports etc.


-Familiarity with GCP's, IHC guidelines.
-Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus
-Experience with using TMF and CTMS systems
-Proficiency in Microsoft Word, Excel and PowerPoint and some knowledge of Access or similar databases required

Full job description and information available upon application…