Regulatory Publisher

2 weeks ago

Pune, 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 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


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 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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