Description
The Packaging and Labeling Manager will be a member of the Pharmaceutical Operations team to support provision of clinical trial materials.Essential duties and responsibilities include but are not limited to the following:
* Participate in developing packaging and labeling requirements for Phase 1 - Phase 4 global studies
* Develop label requirements with approval stakeholders to meet global regulatory requirements and study specifications
* Generate label text and obtain required translations according to procedure
* Work with contract service providers to create packaging plans, resolve issues and support the packaging activities to meet established timelines
* Act as technical reviewer of manufacturing protocols and batch records
* Participate in sourcing strategies for packaging materials, comparators, etc. as needed
* Manage inventories and genealogies of CTM supplies
* Other activities as requested
Requirements:
* 6+ years experience in clinical material preparation including working knowledge of forecasting, packaging and labeling requirements for global clinical studies
* Ability to develop timelines and monitor activities required to meet clinical study needs
* Working knowledge of international clinical cGMPs and GCP requirements
* Working knowledge of MSOffice
* Excellent team skills
* Good written and verbal communication skills
* PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
* 5 - 10% travel
Education:
* Degree in related science area
To find out more about Real please visit www.realstaffing.com