Job Postings

Date Posted

Company

Position

University of North Carolina at Chapel Hill 

Lineberger Comprehensive Cancer Center

Clinical Development Associate

Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The clinical development team assists with regulatory strategic management and FDA interactions for LCCC’s sponsored trials. This position will provide strategic and tactical leadership to UNC investigators in support of their interdisciplinary drug/biologic clinical and translational protocol development and regulatory submissions. This position involves writing, editing, producing and reviewing clinical and/or translational oncology clinical trials protocols, as well as authoring of LOIs (letters of intent) and development of grants to support these clinical protocols. The individual will aid in the preparation of Investigational New Drug (IND) serial submissions and responding to queries from the Food and Drug Administration (FDA).

Regulatory Affairs Manager

(link is through Indeed.com)

The Americas Regulatory Affairs Manager is responsible for overseeing and managing the routine operations of the regulatory affairs department as described in the Major Accountabilities of the Role Profile. In this role, the Manager ensures compliance with applicable regulatory requirements, including those from the US FDA, Health Canada, USDA, and other applicable regulatory agencies, while providing regulatory strategy and support across the business.

Medical Writer (Multiple Openings)

Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.

JobID: 24005096-CAN975