Job
Description
As a Regional Submission Manager - Sponsor-dedicated with CTIS experience at Syneos Health, you will play a crucial role in driving regional submission management strategy and activities for assigned protocols. You will collaborate with major functional areas, including SSU and Study Management, regarding essential core documents and local documentation needed from relevant supplier lines across both HA and EC submission and translation processes. Your responsibilities will include partnering with study teams to manage required regulatory activities, standards, and deliverables associated with CTA submission development. You will be responsible for authoring Annex I and completing relative associated documentation as required. Additionally, you will lead global team efforts to ensure high-quality components and submissions that are compliant with industry, agency, and format guidelines, regulatory strategies, policies, and timelines. In this role, you will prepare, review, and support submissions to HA/Regional CTA Hub to obtain all necessary authorizations/approvals related to the clinical trial conduct. You will also be responsible for coordinating translations for core documents required for submission and managing the compilation for core package build, contributing to CTA and authoring documentation as necessary. Furthermore, you may act as a local country liaison when required and escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities. To qualify for this position, you should have a Bachelor's Degree (Higher Degree Preferred) and independent CTIS experience in initial submission and substantial amendments. You should have the ability to work on multiple highly complex projects simultaneously and possess a strong knowledge of the drug development process, regulatory sciences, CTA and submission management, and publishing. It is essential to have an in-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experience in process development and new technology implementation. Additionally, you should be able to operate seamlessly and influence direct and indirect reports across the organization. Demonstrated understanding of regional and national regulator filing guidelines and dossier requirements is required, along with the ability to lead and deliver through others in a matrix model. Strong decision-making skills in ambiguous or urgent circumstances, excellent communication, presentation, and interpersonal skills, as well as quality-driven and negotiating abilities are also essential for this role. Join Syneos Health to be part of a dynamic team that is passionate about accelerating customer success and changing lives through innovative clinical development solutions. Discover the rewarding career opportunities that await you at Syneos Health.,
