Manager - Clinical Trial Applications

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Responsibilities

• Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
• Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines.
• Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Liaises with Study Management, regarding essential core documents that cross HA and EC submission process.
• Prepare, review and submit submissions to HA/Regional CTA Hub.
• Responsible for the co-ordination of translations for core documents required for submission.
• Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
• Acts as Subject Matter Expert for Regulatory Ops and provides country-level intelligence on clinical trial regulatory(CTR).
• Escalates and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
• Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the Submissions process by collaboration with key customer and supplier groups and business partners.
• Promotes the use of Document Management and Archival systems and standard document authoring.
• Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.
• Operates as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
• Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Dept.
• Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently.