Documentation Specialist
1 day ago
At Talent Software Services, we are seeking a highly skilled Documentation Specialist to join our team. As a key member of our Global Regulatory Affairs & Clinical Safety team, you will play a critical role in supporting the operational aspects of procedural documentation management and advising on documentation strategy.
Key Responsibilities:- Support the development, revision, implementation, and maintenance of procedural documentation related to global Regulatory Affairs and/or Pharmacovigilance activities.
- Collaborate with Business Process Leads, Functional Leads, Document Owners, and Subject Matter Experts (SMEs) to ensure documentation conforms to MRL standards and adequately reflects intended processes.
- Manage the creation and revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation, including Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals.
- Develop and manage integrated project plans, lead and/or complete documentation impact assessments, and support process owners in the development of process maps.
- Facilitate documents through draft, review, and approval cycles to meet required timeframes for release and implementation.
- Maintain and organize current effective documentation within logical groupings/categories to facilitate ease of access for Global Regulatory Affairs & Clinical Safety end users.
- Support and manage requests for documentation for Global Regulatory Affairs & Clinical Safety internal audits and inspections for process documentation.
- Bachelor's degree or higher.
- 6+ years of industry experience and familiarity with Veeva Vault Quality Docs.
We offer a dynamic and challenging work environment, and we are committed to helping our employees grow and develop their careers. If you are a motivated and detail-oriented individual with a passion for documentation and regulatory affairs, we encourage you to apply for this exciting opportunity.
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