Senior Manager, Document Quality Reviewer, Vaccines
Pfizer
1 month ago
Remote
United States
Operations
What You Will Achieve
- Manage projects and conduct document quality review (DQR) on the clinical components of documents authored by Vaccine Clinical Research (VCR) across VCR global sites.
- Perform clinical data checking/consistency checking, clinical editing, and checks for uniformity and compliance with Pfizer and clinical guidelines.
How You Will Achieve It
- Independently perform DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses); document quality review findings; identify and immediately escalate significant findings.
- Participate in resolution of findings with document authors, clinicians, and other team members (as needed).
- Manage DQR document archival processes and procedures.
- Independently produce style guides, manuals, and quality review work guides for Vaccine programs and documents; coordinate agreement on style issues within and across projects.
- Lead and/or manage completion of complex tasks; communicate initial findings.
- Analyze DQR findings to identify root causes; participate in corrective action planning; lead compilation/analysis of data quality metrics.
- Serve as SME for DQR/QC; lead quality activities to set standards for collaboration, deliver project commitments, and ensure customer satisfaction.
- Participate on project teams/task forces/working groups; develop recommendations for cross-Pfizer processes to align with quality goals.
- Evaluate routine processes/procedures to eliminate or streamline; recommend process improvements to reduce recurring document errors.
Basic Qualifications
- BS/BA degree (preferably in English/journalism/communications or biological science).
- 7+ years of experience in medical writing and/or DQR/QC of clinical documents in the pharmaceutical/healthcare industry.
- Thorough understanding of scientific principles; medical terminology; familiarity with the AMA Manual.
- Ability to edit for clarity; strong verbal, written, and interpersonal communication skills; rigorous attention to detail while working rapidly and accurately.
Preferred Qualifications
- Advanced degree with relevant medical editing or document quality review experience (preferred).
- Prior experience preparing clinical regulatory documents in a clinical setting, pharmaceutical company, or CRO (helpful).
Technical Skills
- Analytical skills and statistical aptitude; clinical knowledge and expertise; editing skills; project and process management; quality review skills; strategic thinking; technical learning; priority setting; problem solving.
Physical/Mental Requirements
- Work performed at a desk, primarily with laptop, monitor, and keyboard.
Work Schedule / Location
- 40-hour week during core business hours (Mon–Fri); occasional work beyond regular hours, including evenings/weekends.
- Remote.
Benefits / Compensation
- Annual base salary range: $106,000.00 to $176,600.00.
- Eligible for Global Performance Plan bonus target of 15.0% of base salary and participation in share-based long-term incentive program.
- 401(k) with Pfizer matching contributions; additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
Relocation / Authorization (job-specific)
- Relocation assistance may be available based on business needs and/or eligibility.
- Candidates must be authorized to be employed in the U.S.; U.S. work visa sponsorship is not available for this role now or in the future.
- Manage projects and conduct document quality review (DQR) on the clinical components of documents authored by Vaccine Clinical Research (VCR) across VCR global sites.
- Perform clinical data checking/consistency checking, clinical editing, and checks for uniformity and compliance with Pfizer and clinical guidelines.
How You Will Achieve It
- Independently perform DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses); document quality review findings; identify and immediately escalate significant findings.
- Participate in resolution of findings with document authors, clinicians, and other team members (as needed).
- Manage DQR document archival processes and procedures.
- Independently produce style guides, manuals, and quality review work guides for Vaccine programs and documents; coordinate agreement on style issues within and across projects.
- Lead and/or manage completion of complex tasks; communicate initial findings.
- Analyze DQR findings to identify root causes; participate in corrective action planning; lead compilation/analysis of data quality metrics.
- Serve as SME for DQR/QC; lead quality activities to set standards for collaboration, deliver project commitments, and ensure customer satisfaction.
- Participate on project teams/task forces/working groups; develop recommendations for cross-Pfizer processes to align with quality goals.
- Evaluate routine processes/procedures to eliminate or streamline; recommend process improvements to reduce recurring document errors.
Basic Qualifications
- BS/BA degree (preferably in English/journalism/communications or biological science).
- 7+ years of experience in medical writing and/or DQR/QC of clinical documents in the pharmaceutical/healthcare industry.
- Thorough understanding of scientific principles; medical terminology; familiarity with the AMA Manual.
- Ability to edit for clarity; strong verbal, written, and interpersonal communication skills; rigorous attention to detail while working rapidly and accurately.
Preferred Qualifications
- Advanced degree with relevant medical editing or document quality review experience (preferred).
- Prior experience preparing clinical regulatory documents in a clinical setting, pharmaceutical company, or CRO (helpful).
Technical Skills
- Analytical skills and statistical aptitude; clinical knowledge and expertise; editing skills; project and process management; quality review skills; strategic thinking; technical learning; priority setting; problem solving.
Physical/Mental Requirements
- Work performed at a desk, primarily with laptop, monitor, and keyboard.
Work Schedule / Location
- 40-hour week during core business hours (Mon–Fri); occasional work beyond regular hours, including evenings/weekends.
- Remote.
Benefits / Compensation
- Annual base salary range: $106,000.00 to $176,600.00.
- Eligible for Global Performance Plan bonus target of 15.0% of base salary and participation in share-based long-term incentive program.
- 401(k) with Pfizer matching contributions; additional retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
Relocation / Authorization (job-specific)
- Relocation assistance may be available based on business needs and/or eligibility.
- Candidates must be authorized to be employed in the U.S.; U.S. work visa sponsorship is not available for this role now or in the future.