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
- 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.
- 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