Regulatory Publisher II

OVERVIEW

The Regulatory Publisher II is responsible for working with Regulatory Affairs to publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other 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 requires the employee to implement publishing processes across multiple teams.

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
• 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
• Strong 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
• 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
• 3-4 years of 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; professional attitude and demeanor

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