Electronic Document Specialist
13 hours ago
This is a unique opportunity to make a meaningful impact within the pharmaceutical industry by preparing and managing high-quality documents for regulatory submissions. As an Electronic Document Preparation Specialist, you will be responsible for creating, formatting, and maintaining documents that meet regulatory guidelines and company standards.
">The ideal candidate will have experience in electronic documentation preparation, with a focus on regulatory submissions for clinical trials and registrations. They will also possess a strong understanding of document management software and tools, as well as relevant regulatory information management systems and software.
">- Key Responsibilities:
- Document Preparation: Create and format documents, reports, and other submissions-related materials according to regulatory guidelines and company requirements.
- Submission-ready Compliance: Ensure all documents meet specifications outlined for electronic submissions, including file formats, naming conventions, and metadata requirements.
- Quality Assurance/Control: Conduct quality checks on documents to ensure accuracy, completeness, and compliance with regulatory and company standards.
- Communication and Collaboration: Collaborate with cross-functional teams to gather necessary information and documents for submission-readiness.
- Requirements:
- Experience in electronic documentation preparation, with a focus on regulatory submissions for clinical trials and registrations.
- Strong understanding of document management software and tools, as well as relevant regulatory information management systems and software.
- Ability to troubleshoot technical issues related to document formatting and conversion.
- Effective communication skills to collaborate with cross-functional teams.
- Benefits:
- Opportunity to work with a supportive and future-focused team.
- Chance to grow your talent and drive your career.
- Thoughtful rewards package that recognizes your contribution and amplifies your impact.
We are seeking a skilled Electronic Document Preparation Specialist to join our team. If you have a passion for document preparation and a strong understanding of regulatory requirements, we encourage you to apply.
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