Overview
eCTD Submission Manager II – Remote Jobs in Illinois, United States at The Fountain Group
Title: eCTD Submission Manager II – Remote
Company: The Fountain Group
Location: Illinois, United States
Details for the position are as follows:
12-month contract to start with the possibility of extension or conversion depending on performance and budget.
Rate: $60-65.77
Location: 100% remote
Job Description:
Performs eCTD submission management across Biogen’s product portfolio to Health Authorities for global development and lifecycle management submissions.
Oversee outsourced publishing deliverables to ensure successful execution of operational activities for assigned products.
Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Responsible for electronic submissions and documents meeting regulatory agency and Biogen submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
Competent in the use of electronic document management and submissions publishing tools.
Required Skills:
Bachelor’s degree required
3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.
Regulatory Systems Expertise (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
eCTD Submission Management required
UAT testing experience preferred
IT/system implementation preferred
