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Sr. RA Consultant
Parexel International Corporation
Taipei, Taiwa
*This role has the responsibility as Global/Regional CTA Submission (Associate) Manager
Job Description:
• Drives global submission management strategy and activities for assigned protocols.
• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA (Clinical Trials Application) submission development including authoring of Annex I and completion of relative associated documentation as required
• Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
• 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 Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes
• Prepare, review and submit 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
• Manages the compilation for core package build, contributing to CTA and authoring documentation as required
• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
• Discussed with relevant SMEs the interpretation of dossier requirements
QualificationsJob Qualification:
• B.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
Job posted: 2021-10-26