Work from Home Job Opportunity at Pfizer; Medical Writing Quality Reviewer
Medical Writing Quality Reviewer
Medical Writing Quality Reviewer – Job Opportunity at Pfizer
Pfizer is seeking a Medical Writing Quality Reviewer to join their team in India, either in Chennai or remotely. The role involves conducting quality reviews and ensuring the accuracy, compliance, and submission readiness of documents prepared by authors in Medical Writing and other clinical groups. The documents include protocols, clinical study reports, disclosure documents, and regulatory responses. The ideal candidate should have a Bachelor’s degree, experience in document QC and/or medical writing in the pharmaceutical or biotech industry, and excellent organizational and communication skills. The role offers flexibility in work location.
locations; India – Chennai, India – Remote
job requisition id; 4882272
JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
The role manages and conducts quality reviews to support delivering 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
Indicate the primary responsibilities critical to the job.
Quality Reviews; With minimal supervision, perform quality reviews and participate in quality projects by agreed-upon timelines.
- Verify the accuracy of document content using source documents, including clinical and 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 / SKILLS
Indicate qualifications and skills necessary for the performance of responsibilities, including education, relevant experience, licenses, certifications and other job-related technical and managerial skills- At 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 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.
- A high degree of fluency in written and spoken English.
- Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
- Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).
Work Location Assignment: Flexible
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction.
