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Regulatory Publisher
TransPerfectIndia28 days ago
Job descriptionDemonstrate attention to detail- Ability to successfully train & learn under the more advanced Specialists on how to conduct all quality assurance reviews in the specified areas- Ability to prioritize critical needs, act decisively, and handle a high volume of complex tasks within a given timeframe- Good communication and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation, and team-building skills- Highly proficient computer skills including Adobe Acrobat DC and MS Word, Electronic submission software,- Windows and MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) or similar software- Demonstrated ability and willingness to learn new products and processes independently and quickly- Ability to work under deadlines to meet project timelines, including the ability to modify work schedules when needed Minimum Bachelor’s degree or its equivalent- 0 to 2 years experience in eCTD Regulatory Publishing- Problem-solving abilities and adaptability- Direct knowledge of or willingness to learn eCTD publishing tools. A rapid increase in eCTD document structure, system, & content knowledge is expected- Technical writing and documentation knowledge- Strong technical aptitude- Confidence and assertiveness Strong attention to detail, multitasking, project management, teamwork, and communication skills- Adaptable / Flexible approach to work- Self-starter with excellent organization and time management skills- Result-oriented, biased to action
Description :
- Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards- Report 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 monthly- Develop a thorough understanding of all aspects of the publishing software, tools, process, and output requirements- Perform 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 guide- Maintain knowledge of current regional regulations in regard to application format.- Understand, interpret, and apply Agency regulations and guidelines related to eCTD submissions- Dispatch submissions to Regulatory Authorities via agency portal, through customers or directly- Build a good working partnership with Service Desk and Solutions Engineering Teams to ensure efficiency for project deliverables and timelines are adhered and SLAs are kept- Participate in submission team meetings to plan and track submissions and relevant documents as assigned- Complete all other tasks that are deemed appropriate for this role and assigned by the manager / supervisor
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Desired Experience and Skills