What You Will Achieve
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.
How You Will Achieve It
Quality Reviews
With minimal supervision, perform quality reviews and participate to quality projects in accordance with agreed
upon timelines.
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.
Verify internal consistency within a document and across related documents
Verify uniformity and compliance of documents with internal and external standards (e.g., document templates,
Company Style Guide, Publishing Requirements).
Record findings and identify appropriate corrections to address findings.
Collaborate with document authors and other team members to resolve findings.
Identify, communicate, and resolve issues impacting document timelines.
Propose recommendations for process improvements that could reduce recurring errors in documents.
Special Assignments/Projects
Participate in quality processes and process improvement initiatives.
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. BS/BA +5 years, MS/MA +3 years of experience in document QC and/or medical writing in the pharmaceutical or biotech industry. 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. Strong organizational skills and ability to prioritize multiple projects and meet deadlines. High degree of fluency in written and spoken English. Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical