TransPerfect | Regulatory Publisher II

9 hours ago

Delhi, India TransPerfect Full time
OVERVIEWThe Regulatory Publisher II is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for submission to ensure compliance with government acts and regulations. This position also requires the employee to implement publishing processes across multiple teams.

DESCRIPTIONReport directly to the Team Manager on all team and client issues, project work, project deliverables associated timelines, ensuring SLAs are satisfied, and deliver reporting – daily, weekly, or monthlyPublish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standardsDevelop a thorough understanding of all aspects of the publishing software, tools, process, and output requirementsPerform eCTD readiness/pre-publishing tasks (i.e., formatting, bookmarking, and document navigation)Perform tasks within the publishing system (creating eCTD submissions; lifecycle management; assigning documents; adding cross-references hyperlinks)Complete high-quality submissions following regulatory guidelines and internal processes within timelinesEnsure consistency across regulatory submission documents following the regulatory style guidePerform publishing QC tasks within the electronic publishing system and QC of the published output to ensure high submission qualityPerform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolutionMaintain knowledge of current regional regulations in regard to application formatUnderstand, interpret, and apply Agency regulations and guidelines related to eCTD submissionsDispatch submissions to Regulatory Authorities via agency portal, through customers or directlyBuild a good working partnership with Service Desk and Solutions Engineering Teams to ensure efficiency for project deliverables and timelines are adhered and SLAs are keptParticipate in submission team meetings to plan and track submissions and relevant documents as assignedComplete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

REQUIRED SKILLSDemonstrate attention to detailAbility to successfully train & learn under the more advanced Specialists on how to conduct all quality assurance reviews in the specified areasAbility to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframeStrong communication and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation, and team-building skillsHighly proficient computer skills including Adobe Acrobat DC and MS Word, Electronic submission software, Windows and MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) or similar softwareAbility to work under deadlines to meet project timelines, including the ability to modify work schedules when neededDemonstrated ability and willingness to learn new products and processes independently and quickly

REQUIRED EXPERIENCE AND QUALIFICATIONSMinimum Bachelor’s degree or its equivalent3-4 years of experience in eCTD Regulatory Publishing requiredDirect knowledge of or willingness to learn eCTD publishing toolsProblem-solving abilities and adaptabilityTechnical writing and documentation knowledgeStrong technical aptitudeConfidence and assertiveness; professional attitude and demeanor

DESIRED SKILLS AND EXPERIENCEStrong attention to detail, organization, multitasking, project management, teamwork, and communication skillsAdaptable / Flexible approach to workSelf-starter with excellent organization and time management skillsResult-oriented, biased to action

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