Senior Regulatory Document Coordinator

Sr Reg Doc Coord

•    The Junior Publisher is responsible for supporting the compilation, publishing, and technical quality control of Regulatory submissions 
•    Supports production of high-quality dossiers by handling the collection of components, publishing / assembly, quality review, and delivery of submissions in paper and electronic format (like NeeS, eCTD, etc.). 
•    Supports electronic submissions, performs bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines.
•    Assists with the collection of CSR appendices in accordance with ICH guidelines and IQVIA standard practices, with guidance from the lead medical writer for the CSR
•    Interacts with internal clients. May have some external interactions, mostly directed by senior staff
•    Takes responsibility for managing day-to-day workload for assigned tasks, in collaboration with senior staff
•    Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing/regulatory submissions
•    Complies with Company SOPs and participates in the implementation of new SOPs

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Experience Level

Senior Level