Pfizer Medical Writing Quality Reviewer Role! Apply Now!

• India – Remote
• India – Delhi
• India – Chennai
• India – Mumbai
• India – Bangalore

Time Type: Full time
Posted On: Posted Today
Job Requisition ID: 4917392

What You Will Achieve
The role manages and conducts quality reviews to support the 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 in quality projects in accordance with agreed-upon timelines.
• Verify the 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 a minimum, Bachelor’s 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 relationships.

Work Location Assignment: Flexible