Regulatory Content Specialist
6 days ago
Job Title: Regulatory Content Specialist
Location: VCLS
About the Job:
VCLS is seeking a skilled Regulatory Content Specialist to join our team. As a key member of our project coordination and quality assurance team, you will assist in the preparation of regulatory documents and provide project management support.
Key Responsibilities:
- Document Management:
- Prepare and review regulatory documents, including protocols, clinical study reports, and regulatory submissions.
- Organize and categorize documents, ensuring accessibility and version control.
- Support e-publishing activities (formatting, creating eCTD compliant PDFs, hyperlinking, bookmarking, etc.).
- Project Coordination:
- Support project managers in coordinating activities related to regulatory submissions and project milestones.
- Coordinate with cross-functional teams to ensure completeness and accuracy of submissions.
- Track submission progress and address any queries or issues raised during the review process.
- Quality Assurance:
- Stay up-to-date with regulatory guidelines and industry standards.
- Conduct document audits to ensure compliance with regulatory requirements and internal standards.
Requirements:
- Experience: Proven work experience in project management.
- Technology: Expert level proficiency in Windows and MS Office Suite.
- Values: Embody our core values - People, Innovation, Passion, and Excellence.
- Detail-Oriented: Possess a meticulous eye for accuracy and strong organizational skills.
- Team Player: Thrive in a collaborative environment and demonstrate excellent communication skills.
Benefits:
- Why VCLS: Make a Difference, Learn and Grow, Hybrid Flexibility, Dynamic Environment, Growth Potential.
- Salary: $65,000 - $90,000 per annum.
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