Medical Writer for Regulatory Deliverables
2 weeks ago
Job Description: We are seeking an experienced medical writer to support a team member on maternity leave. The successful candidate will be responsible for authoring high-quality regulatory writing deliverables, including clinical, safety, and regulatory documents.
Key Responsibilities:
- Author and edit regulatory writing deliverables, such as protocols, study reports, patient narratives, and plain language summaries.
- Adhere to established regulatory standards and guidelines, including ICH E3/E6(R2) and EU MDR/IVDR.
- Strive to complete writing deliverables on time and within budget.
- Interact and communicate directly with clients and subject matter experts.
- Coordinate QC reviews of documents and maintain audit trails of changes.
- Review statistical analysis plans and table/figure/listing shells for appropriate content, grammar, format, and consistency.
Requirements:
- Minimum 3 years of experience writing clinical and regulatory documents for drugs, biologics, medical devices/diagnostics.
- Experience writing & editing scientific documents or reviewing scientific data preferred.
- Experience in phase I and II & preclinical study experience is vital for this role.
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