Position Title: Regulatory Publishing Manager - Clinical Operations
Work Location: Princeton, NJ, 08540 & San Diego, CA, 92130
Assignment Duration: 6 months
 
Position Summary: The Manager/Sr. Manager, Regulatory Publishing is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices.
 
Key Responsibilities:

• Using eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices.
• For authored documents, ensure formatting is applied consistently according to our organization’s Style Guide.
• As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness.
• QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues.
• Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of our organization’s document management system.
• For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of our organization’s document management system and tracking of appendices).
• For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion.
• As needed, work with system business owners, IT, and QA to support system implementations and updates including execution of validation scripts.

 
Qualification & Experience:
Must have experience with/be proficient in the following:

• Thorough working knowledge of eCTD guidance (e.g., ICH, FDA, EMA, etc.), requirements, and technologies.
• Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems.
• Demonstrated ability to work collaboratively with IT, QA, and vendors to develop, implement, and maintain regulatory systems.
• Working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Acrobat, DXC Toolbox, authoring templates).
• Understanding of computer system validation principles and change control processes.
• Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports.
• Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions.

Education:

• Bachelor’s degree in business administration, a life sciences discipline, information technology, etc. A minimum of 5 years in Regulatory Operations or a related, relevant function.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $47.00/hr.