ClinChoice

We are seeking a Principal Programmer to ensure clinical data deliverables meet FDA regulatory requirements, CDISC standards, and the FDA Technical Conformance Guide (TCG). This position requires expertise in performing compliance and conformance checks for submission data packages. You will provide standardized guidance to biotech companies on FDA submission expectations.

Seeking a highly organized, detail-oriented Labeling Artwork Program Manager to lead end-to-end program management for the development, revision, and approval of packaging and labeling artwork across a consumer health portfolio. The role involves acting as a cross-functional liaison, ensuring labeling projects are executed accurately, on time, and in compliance with global regulatory and brand requirements.

Seeking a confident Senior/Principal Statistical Programmer Consultant capable of working independently and establishing a high-trust environment with the client’s counterparts. Responsibilities include participating in CRF design, producing data listings, integrating data across studies, and validating programs. The role involves collaborating with Biometrics functions and executing ad-hoc requests.