TransPerfect | Regulatory Publisher

21 hours ago

Delhi, India TransPerfect Full time
Description:Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standardsReport 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 monthlyDevelop 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-reference hyperlinks)Complete high-quality submissions following regulatory guidelines and internal processes within timeliness.Ensure consistency across regulatory submission documents following the regulatory style guideMaintain knowledge of current regional regulations in regard to application format.Understand, 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 Skills:Demonstrate 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 timeframeGood 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 softwareDemonstrated ability and willingness to learn new products and processes independently and quicklyAbility to work under deadlines to meet project timelines, including the ability to modify work schedules when needed

Required Experience and Qualifications:Minimum Bachelor’s degree or its equivalent0 to 2 years experience in eCTD Regulatory PublishingProblem-solving abilities and adaptabilityDirect knowledge of or willingness to learn eCTD publishing tools. A rapid increase in eCTD document structure, system, & content knowledge is expectedTechnical writing and documentation knowledgeStrong technical aptitudeConfidence and assertiveness

Desired Experience and SkillsStrong attention to detail, 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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