What are the responsibilities and job description for the Documentation Specialist position at Voisin Consulting SARL?
As Consultant : Author and deliver high-quality scientific documents in a timely manner to align with product development and registration strategy, addressing multiple client projects.
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As Lead Consultant : Ensure smooth and close communication with the client. Monitor, prioritize, and supervise project activities. Communicate appropriately with project team members and the Account Manager.
Manage and mentor less experienced colleagues, depending on organizational needs.
- Management of Publishing projects, maintaining submission trackers, ensuring quality and timeliness of Client deliverables and submissions.
- Prepare, assemble, and submit applications (IND / CTA / NDA / MAA / NDA).
- Create eCTD compliant PDFs, publish sequences in docuBridge, and create internal and external document hyperlinks.
- Work in close collaboration with Global Regulatory teams when Publishing is included in a larger project.
- Perform technical QC of submissions before dispatch to Regulatory Authorities, ensuring submissions are published in accordance with relevant ICH and local guidelines and internal procedures.
- Dispatch submissions to Regulatory Authorities via agency portals.
- Communicate with regulatory agencies regarding electronic regulatory submissions, answering technical queries and resolving technical issues (with relevant IT support).
- Stay abreast of ICH and regional requirements and ensure publishing software aligns with regional eCTD validation criteria.
- Create tools for easier management of submissions / tasks.
- Participate in the update of internal eCTD Distinct Technical Procedures (DTPs).
- Provide training and mentoring to eCTD Specialists (when applicable).
- Other duties as assigned.
Minimum Requirements :
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