eCTD Publishing Specialist

eCTD Publishing Specialist

About the Opportunity:

• Prepare, QC review and submit pre-and post-approval submissions (IND/CTA/NDA/MAA/NDA, etc.) to the Food and Drug Administration and other Health Authorities, using applicable guidelines and regulations.
• Perform eCTD readiness/pre-publishing tasks (i.e., formatting and document navigation).
• Maintain eCTD lifecycle management.

• Complete high-quality submissions following regulatory guidelines and internal processes within timelines.
• Understand, interpret and apply Agency regulations and guidelines related to eCTD submissions
• Ensure knowledge of current eCTD specifications and guidelines.
• Utilize an array of document management, tracking, publishing and eCTD building tools.
• Participate in submission team meetings to plan and track submissions and relevant documents as assigned.

Requirements

Experience:

• Prior Regulatory Operations experience (eCTD publishing and electronic document processing).
• Experience in a consulting firm is a plus.
• Advanced in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.

• Outstanding work ethic; must be able to perform in fast paced, multi-product environment.
• Responsible, organized, detail-oriented, self-motivated, quick learner, positive attitude, computer savvy.
• Prior eCTD publishing & electronic processing experience.
• Degree in a related field preferred.

Personal Attributes and Skills:

• Strong written and verbal communication skills, and possess good interpersonal and team working skills
• Highly proficient computer skills including:

• Electronic submission software (e.g. docuBridge) – prior experience a plus
• Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) or similar software) and Adobe

• Problem-solving abilities, adaptability, and a self-starter.

• Ability to work under deadlines to meet project timelines, including the ability to have work schedule flexibility.