CTA Submission Manager (In Vitro Diagnostic submission Specialist)

CTA submission manager (in Vitro Diagnostis Regulations - IVDR)

The Regional/Global CTA Submission Manager (CTA-SM) is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs and IVDR.  They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.

• Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
• Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
• Support and 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
• Liaise with Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
• Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct
• Responsible for the co-ordination of translations for core documents required for submission
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required
• May be responsible for proactive processing of incoming request for information (RFIs) by daily monitoring RFI-dedicated mailbox and Clinical Trials Information System (CTIS) portal and reporting RFIs to study teams
• May be responsible for proactive processing of payments
• May manage IVD submission development and completion of relative associated documentation as required and/ or act as applicant for IVD when required
• May act as local country liaison when required
• 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

• S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA and Central Ethics processes globally
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• IVDR submission experience