Regulatory Document Quality Specialist
1 week ago
Regulatory Document Quality Specialist Role Summary:
This role is focused on providing high-quality document checking services to support the preparation of regulatory documents in the pharmaceutical industry.
Key Responsibilities:
- Perform quality control checks on documents, including compilation, formatting, tabulation, and pagination.
- Verify document content and style adhere to FDA/EMA or other regulatory guidelines and departmental SOPs.
- Collaborate with medical writers to plan, coordinate, and execute complex QC activities.
- Lead other Document Quality Reviewers in QCs involving multiple documents or requiring specialist knowledge.
- Provide oversight to ensure quality and consistency across multiple QCs.
Requirements:
- Excellent written and spoken English skills.
- Well-established proof-reading skills and high attention to detail.
- High level of numeracy and understanding of statistics.
- Excellent interpersonal, verbal, and written communication skills.
- Ability to manage multiple tasks, prioritize workload, and work in a solutions-driven manner.
Preferred Qualifications:
- Experience in the pharmaceutical industry and medical writing.
- Knowledge of regulatory documents and ICH-GCP guidelines.
- Advanced word processing skills, including expertise in Word for Windows and document formatting standards.
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