TransPerfect | Team Lead, Regulatory Publisher

5 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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