The Document Review Specialist II effectively reviews highly technical documents to ensure they meet or exceed client expectations. Documents include regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols, and publications. This role ensures data integrity, scientific clarity, and adherence to regulatory standards.
Essential Functions:
- Review highly technical documents created within or outside the company to ensure quality standards.
- Verify scientific logic and clarity, checking data consistency against source documents and regulatory guidelines.
- Edit documents for accuracy, consistency, and grammatical correctness.
- Adjust schedules to accommodate priority review requests.
- Revise scientific language for clarity and appropriateness.
- Proactively communicate with authors to ensure alignment with preferences and scientific standards.
- Stay updated on current guidelines, templates, and industry standards.
Qualifications:
Education and Experience:
- Bachelor’s degree or equivalent academic qualification.
- Minimum 4+ years of relevant experience in medical writing or document review.
Knowledge, Skills, and Abilities:
- Ability to focus on document details while understanding overall objectives.
- Strong knowledge of medical writing methods, techniques, and procedures.
- Excellent analytical skills and familiarity with medical terminology, statistical concepts, GCP, ICH guidelines, FDA requirements, and international regulatory standards.
- Detail-oriented with proficient grammatical and communication skills.
- Advanced computer literacy, including document management systems.
- Ability to work under pressure, independently, and in a team environment.
- Organizational and planning skills with the ability to work in a cross-cultural, geographically dispersed team.
