Pfizer USA Jobs – Medical Writing Quality

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

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