Key Responsibilities
Education:
- Responsible for meeting the main objectives/deliverables of the assigned project within the established timelines with a high level of quality, consistency, and accuracy.
- Perform QC review of documents per established checklists (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, Module 2 clinical summary documents and regulatory packages).
- Verify data in documents against the source tables, figures, and listings and format tables.
- Monitors timelines for assigned projects and updates the lead medical writer, if deliverables are at risk.
- Provides technical support and expertise as appropriate.
- Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process.
- Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style and/or the Sponsor style guidelines as well as established medical writing internal checklists and best practices.
- Performs quality review of assigned documents to ensure accuracy.
- Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
- Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
- May compile medical writing deliverables.
Education:
- Bachelor’s degree required; preferred fields include Science, English, or Communications.
- 2–3 years of relevant industry experience in quality control/review of clinical regulatory documents, or related areas such as quality assurance, clinical research, medical writing, regulatory affairs, or product development/R&D.
- Technical Skills: proficient in MS Word, Adobe PRO, and Veeva RIM.
- Strong understanding of the organization and content of clinical documents, including eCTD structure and Common Technical Document (CTD) templates.
- Familiarity with regulatory submission standards and drug development processes.
- Exceptional attention to detail, analytical and critical-thinking skills.
- Excellent written and verbal communication; strong interpersonal and organizational skills.
- Ability to manage conflict and prioritize multiple tasks/projects.
- Demonstrated success working cross-functionally in collaborative team environments.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Administrative -
Industries
Research Services
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