Job Description :
Position: S-Cubed Regulatory Publisher
Location: Princeton,NJ
Contarct: 24 Months

Job Description

4 Years Submission Publishing experience

- Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems. - Demonstrate ability to function autonomously in a matrix environment. - Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions. - Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal skills. - Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor. - All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes. - Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents.

Role:
- Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure.

- Support Global Regulatory Leads in the planning, development, and publishing of submissions.

- Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.

- Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.

- Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.

- Dispatch submissions through the FDA Gateway

- Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application.

- Archive submissions both electronic and paper.