Team Lead, Regulatory Publisher

6 days ago

Pune, India TransPerfect Full time

OVERVIEW

The Team Lead, Regulatory Publisher is responsible for leading the Regulatory Affairs related work such as publishing Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, 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 provides mentorship and guidance to the Technical Services Regulatory Publication group and will require to meet all client timelines and deliverables. This position could have a Technical focus or Project focus.


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
  • Oversee the task completed by a Junior Regulatory Publisher such as Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards
  • Perform sampling QC on the task completed by the team to ensure the quality deliverables
  • Responsible for daily work allocation, completion of tasks, and delivery to the client
  • Responsible for generating the KPI associated with the regulatory publishing group
  • Develop a thorough understanding of all aspects of the publishing software, tools, process, and output requirements
  • 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 gap and feedback to the team for improvement of the process
  • Attend client meetings as needed. 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
  • 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
  • Complete all other tasks that are deemed appropriate for the role and assigned by reporting manager


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
  • Proactivity to learn 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
  • 6+ years’ experience in eCTD Regulatory Publishing required
  • Technical writing and documentation knowledge
  • Strong knowledge eCTD process and or willingness to learn eCTD publishing tools


DESIRED SKILLS AND EXPERIENCE

  • Line management experience adds an advantage
  • Strong attention to detail, organization, multitasking, project management, teamwork, and communication skills
  • Problem-solving abilities, adaptable, and a self-starter
  • Strong technical aptitude
  • Confidence and assertiveness
  • Adaptable / Flexible approach to work
  • Self-starter with excellent organization and time management skills
  • Result-oriented, biased to action

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