



Deliverables: Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, etc. Work with Study Teams and partners to maintain and track relevant activities in CTMS. Creation/distribution of regulatory binders Timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions. Distribution of safety documentation to other functional groups in support of safety committee meetings as requested (supporting role). Creation and generation of system reports. Provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs Assist with Device tracking and ordering if required and if applicable.