Regulatory publisher
11 hours ago
Description: Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, 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 e CTD readiness/pre-publishing tasks (i.e., formatting, bookmarking, and document navigation) Perform tasks within the publishing system (creating e CTD 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 e CTD 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 Required Skills: Demonstrate 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, Power Point, Share Point) 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 Required Experience and Qualifications: Minimum Bachelor’s degree or its equivalent 0 to 2 years experience in e CTD Regulatory Publishing Problem-solving abilities and adaptability Direct knowledge of or willingness to learn e CTD publishing tools. A rapid increase in e CTD document structure, system, & content knowledge is expected Technical writing and documentation knowledge Strong technical aptitude Confidence and assertiveness Desired Experience and Skills 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
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Regulatory Publisher
6 days ago
Pune, India TransPerfect Full timeDescription: 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...
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Regulatory Publisher
5 days ago
Pune, India TransPerfect Full timeDescription: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 –...
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Senior regulatory publisher
4 days ago
Pune, India TransPerfect Full timeOVERVIEWThe Senior Regulatory Publisher is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for...
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Regulatory publisher i
11 hours ago
Pune, India TransPerfect Full timeOVERVIEW The Regulatory Publisher I is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, and other applicable electronic publishing standards, as well as to prepare, assemble, and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for...
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Regulatory publisher ii
4 days ago
Pune, India TransPerfect Full timeOVERVIEWThe 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, e CTD, and other applicable electronic publishing standards, as well as to prepare, assemble and submit applications (IND/CTA/NDA/MAA/NDA, etc.) for submission...
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Senior Regulatory Publisher
6 days ago
Pune, India TransPerfect Full timeOVERVIEWThe Senior Regulatory Publisher 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...
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Senior Regulatory Publisher
6 days ago
Pune, India TransPerfect Full timeOVERVIEW The Senior Regulatory Publisher 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...
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Senior Regulatory Publisher
6 days ago
Pune, India TransPerfect Full timeOVERVIEW The Senior Regulatory Publisher 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...
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Senior Regulatory Publisher
5 days ago
Pune, India TransPerfect Full timeOVERVIEWThe Senior Regulatory Publisher 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...
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Senior regulatory publisher
11 hours ago
Pune, India TransPerfect Full timeDescription: 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 Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, and other applicable...
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Regulatory Publisher II
6 days ago
Pune, India TransPerfect Full timeOVERVIEW The 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...
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Regulatory Publisher II
5 days ago
Pune, India TransPerfect Full timeOVERVIEWThe 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...
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Regulatory Publisher I
6 days ago
Pune, India TransPerfect Full timeOVERVIEW The Regulatory Publisher I 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...
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Regulatory Publisher I
5 days ago
Pune, India TransPerfect Full timeOVERVIEWThe Regulatory Publisher I 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...
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Regulatory Publisher II
6 days ago
Pune, India TransPerfect Full timeDescription: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 monthlyPublish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable...
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Regulatory publisher ii
4 days ago
Pune, India TransPerfect Full timeDescription: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 monthlyPublish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, e CTD, and other applicable...
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Senior Regulatory Publisher
6 days ago
Pune, India TransPerfect Full timeDescription: 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 Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable...
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Senior Regulatory Publisher
5 days ago
Pune, India TransPerfect Full timeDescription: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 monthlyPublish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable...
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TransPerfect | Regulatory Publisher
6 days ago
pune, India TransPerfect Full timeDescription: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 –...
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Regulatory Publisher II
6 days ago
Pune, India TransPerfect Full timeDescription: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 monthlyPublish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable...
