Job Description: The role manages and conducts quality reviews to support delivery of accurate, compliant, and submission-ready documents prepared by authors in Medical Writing and other clinical groups. Documents include (but are not limited to) protocols, clinical study reports, disclosure documents, clinical summaries/overviews for marketing applications, briefing documents, regulatory responses and related correspondence and presentation materials. Job Responsibilities: Identify, communicate, and resolve issues impacting document timelines. Propose recommendations for process improvements that could reduce recurring errors in documents. Verify uniformity and compliance of documents with internal and external standards (e.g., document templates, company style guide, publishing requirements). Collaborate with document authors and other team members to resolve findings. Verify internal consistency within a document and across related documents Verify accuracy of document content using source documents including clinical regulatory documents (e.g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings. Record findings and identify appropriate corrections to address findings. With minimal supervision, perform quality reviews and participate to quality projects in accordance with agreed upon timelines. Job Requirements: High degree of fluency in written and spoken English. BS/BA +5 years, MS/MA +3 years of experience in document QC and/or medical writing in the pharmaceutical or biotech industry. Strong organizational skills and ability to prioritize multiple projects and meet deadlines. Ability to work with minimal supervision. Ability to work well under pressure and adapt to change as needed. General understanding of medical terminology, clinical trials, and drug development process. Job Details: Company: Pfizer Vacancy Type: Full Time Job Location: Los Angeles, CA, US Application Deadline: N/A Apply Here careers-trivia.com
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