TransPerfect | Senior Regulatory Publisher
8 hours ago
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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