TransPerfect | Regulatory Publisher I

2 weeks ago

pune, India TransPerfect Full time
OVERVIEW
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 submission to ensure compliance with government acts and regulations. This position also requires the employee to implement publishing processes across multiple teams.
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-references 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
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, 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
REQUIRED EXPERIENCE AND QUALIFICATIONS
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
DESIRED SKILLS AND EXPERIENCE
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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