Team Lead, Regulatory Publisher

7 hours ago

Delhi, India TransPerfect Full time
OVERVIEWThe Team Lead, Regulatory Publisher is responsible for leading the Regulatory Affairs related work such as publishing Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, 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 provides mentorship and guidance to the Technical Services Regulatory Publication group and will require to meet all client timelines and deliverables. This position could have a Technical focus or Project focus.

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 monthlyOversee the task completed by a Junior Regulatory Publisher such as Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standardsPerform sampling QC on the task completed by the team to ensure the quality deliverablesResponsible for daily work allocation, completion of tasks, and delivery to the clientResponsible for generating the KPI associated with the regulatory publishing groupDevelop a thorough understanding of all aspects of the publishing software, tools, process, and output requirementsPerform 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 assignedPeriodically perform review of the process to find any process gap and feedback to the team for improvement of the processAttend client meetings as needed. Represent the TI team as a Regulatory Publishing Subject Matter Expert (SME) as requestedDevelop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documentsTake a proactive role in learning about clients’ industry and business needs and company culture, communicating with the Configuration Team, and providing a high level of serviceComplete all other tasks that are deemed appropriate for the role and assigned by reporting manager

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 timeframeExcellent communication and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation, and team-building skillsProactivity to learn about clients’ industry and business needs and company culture, communicating with the Configuration Team, and providing a high level of serviceHighly 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 equivalent6+ years’ experience in eCTD Regulatory Publishing requiredTechnical writing and documentation knowledgeStrong knowledge eCTD process and or willingness to learn eCTD publishing tools

DESIRED SKILLS AND EXPERIENCELine management experience adds an advantageStrong attention to detail, organization, multitasking, project management, teamwork, and communication skillsProblem-solving abilities, adaptable, and a self-starterStrong technical aptitudeConfidence and assertivenessAdaptable / Flexible approach to workSelf-starter with excellent organization and time management skillsResult-oriented, biased to action

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