Senior Regulatory Publisher

2 weeks ago

Pune, India TransPerfect Full time

Description:

  • 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 electronic publishing standards
  • 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 timelines
  • Ensure consistency across regulatory submission documents following the regulatory style guide
  • Perform publishing QC tasks within the electronic publishing system and QC of the published output to ensure high submission quality
  • Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution
  • 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
  • Periodically perform review of the process to find any process gaps and feedback to the team for improvement of the process
  • Attend client meetings as needed, and represent the TI team as a Regulatory Publishing Subject Matter Expert (SME) as requested
  • Develop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents
  • 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
  • Excellent communication and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation, and team-building skills
  • Take 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 service
  • 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
  • Ability to work under deadlines to meet project timelines, including the ability to modify work schedules when needed
  • Demonstrated ability and willingness to learn new products and processes independently and quickly


Required Experience and Qualifications:

  • Minimum Bachelor’s degree or its equivalent
  • 4+ years’ experience in eCTD Regulatory Publishing required
  • Direct knowledge of or willingness to learn eCTD publishing tools
  • Problem-solving abilities and adaptability
  • Technical writing and documentation knowledge
  • Strong technical aptitude
  • Confidence and assertiveness


Desired Skills and Experience:

  • Strong attention to detail, organization, 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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