ClinChoice Benefits Overview

Provides statistical expertise for Phase III oncology clinical trials, including study design, survival and time-to-event analyses, statistical outputs, TFL and ADaM specifications, interim analyses, and IDMC/DMC support. Collaborates with statistical programming and cross-functional teams, reviews SAS outputs, resolves discrepancies, supports regulatory submissions, and manages deliverables across multiple concurrent studies independently.

Provides regulatory CMC expertise for pharmaceutical and self-care products across new product development, lifecycle management, post-approval changes, and global submissions. Responsibilities include developing CTD Modules 2.3 and 3, assessing CMC changes, guiding manufacturing and analytical requirements, supporting health authority interactions, managing regulatory risks, and collaborating with R&D, Quality, Manufacturing, Supply Chain, and Regulatory teams.

Leads North American regulatory affairs for pharmaceutical and biotech clients, developing global regulatory strategies, overseeing submissions, ensuring compliance, advising on FDA and health authority requirements, and managing regulatory projects. The role includes authoring and compiling IND, CTA, BLA, MAA, and NDA documents, monitoring regulatory changes, mentoring and hiring staff, supporting client presentations, and contributing to department growth and digital process solutions.