SEND Coordinator

Switzerland, Basel-Town, Basel

SEND (Standard Exchange of Non-clinical Data) is a standardized format for data exchange of non-clinical studies with the FDA. SEND is intended to increase the efficiency and quality of scientific review by the FDA and to improve communication between the FDA and industry, with the ultimate goal to phase out paper submissions. FDA now requires sponsors to submit nonclinical data packages (SEND) to accompany all regulatory submissions, beginning in 2017-2018.
Within the Pharmaceutical Science SEND team you will fulfill the role of ‘SEND Coordinator’ and be responsible for  all relevant SEND-enabling activities for various non-clinical safety studies performed in-house and outsourced to Contract Research Organizations (CROs).
 
In this position you will:
  • Keep oversight and own responsibility for the day-to-day logistics of SEND package preparation and ensure compliance with FDA e-data submission regulations.
  • Act on a study specific level as Single Point of Contact (SPOC) for SEND with Roche internal scientists, submission & regulatory, procurement, finance, CROs and external service providers.
  • Interact with CROs to ensure high quality and timely delivery of SEND datasets of outsourced toxicity studies. Order and ensure timely delivery of quality & compliance reviews from external service providers and review these in cooperation with representatives of the appropriate functional areas, the involved scientists and QA.
  • Coordinate & ensure the timely creation of SEND datasets by external service providers of studies performed in-house and assist in monitoring the latest SEND relevant regulatory developments and participate in industry exchange forums such as PhUSE or CDISC and act as the Roche pRED Single Point of Contact (SPOC) for all SEND relevant questions from Health Authorities.
  • Furthermore you will act as the deputy of the SEND Operations Manager, contribute to the ongoing SEND implementation (SENDIG3.1, DART1.0 etc.) and fulfill tasks of SEND related regulatory documents such as the Study Data Standardization Plan (SDSP).