Project Manager (R&D) - Pharmaceutical
My client is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals as well as being an industry leader in pharmaceutical technologies.
This role will be supporting the projects team to coordinate the supply of IMP for clinical studies being performed and to collate information for the completion of Trial Master Files to the standards required by EU GCP.
* To coordinate the supply of IMP for clinical studies being performed and to collate information for the completion of Trial Master Files to the standards required by EU GCP.
* Provide support for Clinical or Pharmacokinetic Studies being run, including compilation of Trial Master Files to GCP standards
* Deliver timelines to UK R&D management meetings on all activities "critical to commercialising a product"
* Coordination of technical batches with support areas
* Responsibility of implementing specific projects and support the introduction and validation of new equipment
* Arrange for necessary documentation for a T-Licence if applicable and other requests from the CRO (through US clinical team)
* Coordinate testing of IMP with QC and QA including non-routine tests
* Will have relevant graduate qualifications in a relevant field
* Experience in analytical chemistry/formulation sciences
* Technical experience of product development in the pharmaceutical industry
* Awareness of how product development fits into the business and the need to supply products on time
* Ability to organise work and to respond appropriately to multiple priorities
* Development of professional relationships with internal and external customers at all levels.
* Understand, recommend and progress continuous improvement strategies
* Good communication skills and ability to make effective contribution to meetings with all personnel at all levels within the organisation
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