Senior Documentation Expert for Global Compliance
3 days ago
Role Overview:
This position involves ensuring a controlled documentation system and record retention in accordance with regulatory requirements.
The ideal candidate will be responsible for maintaining technical and non-technical documentation change systems, classifying and maintaining records, and enforcing documentation formatting standards.
Key Accountabilities:
- Manage medium to small-level global regulatory submission projects.
- Provide strategic input on submission strategy, intelligence, and knowledge required to develop, register, and maintain global products.
- Contribute to the implementation of global systems, tools, and processes to support global development projects and/or marketed products.
- Frequent internal and external contacts.
- Represent the organization on specific projects.
- Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Report technical complaints/adverse events/special case scenarios related to products within 24 hours of receipt.
Essential Skills and Qualifications:
- Cross-cultural experience.
- Functional breadth.
- Collaboration across boundaries.
- Operations management and execution.
- Project management.
Desirable Skills:
- Clinical study reports.
- Data analysis.
- Documentation management.
- Lifesciences.
- Operational excellence.
- Regulatory compliance.
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