Job Description

What You Will AchieveThe 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.How You Will Achieve ItQuality Reviews
\xef\x82\xb7 With minimal supervision, perform quality reviews and participate to quality projects in accordance with agreed
upon timelines.
\xef\x82\xb7 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.
\xef\x82\xb7 Verify internal consistency within a document and across related documents
\xef\x82\xb7 Verify uniformity and compliance of documents with internal and external standards (e.g., document templates,
company style guide, publishing requirements).
\xef\x82\xb7 Record findings and identify appropriate corrections to address findings.
\xef\x82\xb7 Collaborate with document authors and other team members to resolve findings.
\xef\x82\xb7 Identify, communicate, and resolve issues impacting document timelines.
\xef\x82\xb7 Propose recommendations for process improvements that could reduce recurring errors in documents.
Special Assignments/Projects
\xef\x82\xb7 Participate in quality processes and process improvement initiatives.
\xef\x82\xb7 Contribute to the training of colleagues on quality standards and processes.Qualifications

• At minimum Bachelor degree, preferably in a life science discipline. Advanced degree preferred.

\xef\x82\xb7 BS/BA +5 years, MS/MA +3 years of experience in document QC and/or medical writing in the pharmaceutical or
biotech industry.
\xef\x82\xb7 Ability to work with minimal supervision. Ability to work well under pressure and adapt to change as needed.
\xef\x82\xb7 General understanding of medical terminology, clinical trials, and drug development process.
\xef\x82\xb7 Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
\xef\x82\xb7 High degree of fluency in written and spoken English.
\xef\x82\xb7 Excellent interpersonal and communication skills. Ability to establish and maintain professional and productiveWork Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical

Pfizer