validation within pharmaceutical or life sciences projects. Strong knowledge of GxP documentation requirements and regulatory...
and project outcomes. Requirements: Bachelor's degree in engineering, Life Sciences, or a related field. Proven experience...
and mentorship to junior staff or specialists on assigned projects. Requirements: * Bachelor's degree in Regulatory Affairs, Life... Sciences, Engineering, or a related field. 4-6 years of regulatory affairs experience in the medical device or IVD industry...
Responsibilities: Review protocols for CDISC conformance. Review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements. Write and manage SAS code for mapping clinical data to SDTM data structures in conformance with ...
Responsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key m...
Responsibilities: Lead the data management activities from study start-up through the entire data cleaning process until database lock to support the clinical studies. Oversee all project related data management activities and manage pro...
Responsibilities: Independently identify, prioritize, and lead all CDM activities for assigned study. Represent CDM function at internal/external team calls. Communicate and able to provide CDM expertise for DM related activities. Resp...