The opportunity
The QC Specialist provides clinical and scientific quality checks for all clinical study and submission documents for assigned projects. The role is responsible for support of medical writing activities involved in US, European, and other regulatory submissions. The QC Specialist will be accountable for ensuring that deliverables are in line with Teva’s Authoring and QC standards/checklists. The role also includes overseeing vendor management, including contingent workers, where applicable.
Travel Requirements: None
How you’ll spend your day
Provides independent data QC review of clinical regulatory documents including, but not limited to, clinical summary documents, clinical study reports, investigator’s brochures, clinical protocols, briefing books, prior to submission to Health Authorities.
⦁ Performs accurate and precise editing or proofreading ensuring correct spelling, grammar, punctuation and data verification.
⦁ Identifies discrepancies and assesses accuracy and validity of clinical statements in documents.
⦁ Verifies content to ensure accuracy (100% review) of all factual statements within document text compared to post-text sources cited (when appropriate).
⦁ Verifies numeric accuracy (100% review) of all data cited throughout text compared to in-text or post-text tables.
⦁ Verifies all internal and external citations noted within summary document.
⦁ Ensures compliance of document format per the template and style guide.
⦁ Develops and provides factual evidence to support all discrepant findings for review and approval by document authors and subject matter experts of the cross-functional team.
Manages outsourcing of QC to vendor (when appropriate).
⦁ Assesses outsourcing needs and resources
⦁ Estimates/revises budgets
⦁ Serves as primary contact for file sharing, queries, and issue escalation, as needed
Mentors and/or trains new or junior QC reviewers to achieve department set goals for excellence in quality review.
Works cross functionally to continuously improve processes.
