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