Clinical Documents Editor
7 days ago
Key Accountabilities
The Clinical Documents Editor will be responsible for preparing, writing, and editing clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in compliance with internal standards and regulatory guidelines.
Responsibilities
- Collaborate with cross-functional teams to develop and prepare high-quality clinical trial documents and regulatory submissions.
- Conduct literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences.
- Review and validate clinical data to ensure accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements.
- Participate in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables, while providing input and feedback on document content, format, and presentation.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Proficiency in scientific and medical terminology, with excellent written and verbal communication skills, attention to detail, and the ability to convey complex information in a clear and concise manner.
- Strong analytical and critical thinking skills, with the ability to review and interpret clinical data, identify key findings and trends, and communicate results effectively to diverse stakeholders.
- Familiarity with regulatory requirements, industry guidelines, and publication standards governing the preparation and submission of clinical trial documents and scientific manuscripts.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with document management systems, reference management software, and statistical analysis tools preferred.
Why Choose Us
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. Our company values diversity and inclusion, and we welcome applicants from all backgrounds.
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