Senior Medical Writer – Structured Content Authoring
Location
United States
Posted
38 days ago
Salary
Not specified
Job Description
Job Requirements
- Proven experience with SCA platforms.
- Background in medical writing or strong familiarity with regulatory documentation processes.
- Hands-on experience in content creation, review, standardization, and management within a structured content platform.
- Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents.
- Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform.
- Strong problem-solving skills and attention to detail.
- Familiarity with compliance and audit requirements in a GxP environment.
- Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
- Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
Benefits
- Impactful Work: Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide.
- Global Collaboration: Work with diverse teams across the globe in a dynamic, innovative environment.
- Career Growth: Access to professional development programs, mentorship, and opportunities for advancement.
- Flexibility: Enjoy the benefits of a fully remote role with a healthy work-life balance.
- Inclusive Culture: Be part of a company that values diversity, integrity, and collaboration.
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