, and cross-functional collaboration within the life sciences industry. Regulatory Strategy and Submissions. Develop and execute... in regulatory affairs within the life sciences industry, with a focus on clinical regulatory filings. Proven track record...
in life sciences with six years of experience as a CRA or CRC or combination of appropriate education and experiences...
Responsibilities: Software Quality Assurance with Review and Approval Experience for SDLC Deliverables. Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP testin...
Responsibilities: Provide statistical programming support to generate SDTM and ADaM datasets, tables, listings, and figures for individual studies and ISS/Client to FDA, EMA, and other worldwide regulatory agencies. Participate in the re...
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