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Medical Writer- Remote opportunities
Posted 3 days agoViewed
💎 Seniority level: Middle, 3 years
🔍 Industry: Pharmaceutical
⏳ Experience: 3 years
Requirements:
- Minimum of 3 years of experience writing clinical and regulatory documents for drugs, biologics, medical devices/diagnostics for a CRO, pharmaceutical company, or biotechnology company.
- Knowledge of clinical research principles and the ability to interpret and present clinical data and other complex information.
- Understanding of global regulatory bodies and applicable regulations and guidelines.
- Understanding of regulatory submission requirements and processes.
Responsibilities:
- Author (write / edit) high-quality regulatory writing deliverables
- Adhere to established regulatory standards / guidelines
- Strive to complete writing deliverables on time and within budget.
- Interact and communicate directly with clients, lead team meetings
- Interact and collaborate as needed with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
- Coordinate QC reviews of documents and maintain audit trails of changes as applicable.
- Review statistical analysis plans and table / figure / listing shells (as applicable) for appropriate content, grammar, format, and consistency.
- If requested by supervisor, perform QC review (e.g., reviews in-text tables against statistical output).
- Assist with project-related administrative tasks (e.g., creating and maintaining timelines, updating deliverable trackers, and hosting internal / client meetings) with support from senior personnel (as needed).
- Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
- Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out-of-scope tasks to regulatory writing leadership.
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