Senior Manager, Document Quality Reviewer, Vaccines
Pfizer
1 month ago
Remote
United States
Operations
Responsibilities:
- Independently perform document quality review (DQR) of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses); document and escalate significant findings.
- Participate in resolution of findings with authors, clinicians, and team members.
- Manage DQR document archival processes.
- Produce style guides, manuals, and quality review work guides; coordinate style agreement across projects.
- Lead/manage complex tasks; communicate initial findings.
- Analyze DQR findings to identify root causes; participate in corrective action planning; compile/analyze data quality metrics.
- Serve as SME for DQR/QC; lead quality activities and set standards for collaboration, commitments, and customer satisfaction.
- Participate on project teams/task forces; recommend cross-process improvements and streamline routine processes.
Qualifications:
- BS/BA degree (preferably English/journalism/communications or biological science).
- 7+ years of experience in medical writing and/or DQR/QC of clinical documents in pharma/healthcare.
- Strong scientific understanding; medical terminology knowledge; familiarity with the AMA Manual.
- Required: ability to edit for clarity; strong verbal/written/interpersonal skills; rigorous attention to detail while working rapidly/accurately.
Preferred:
- Advanced degree in relevant medical editing/document quality review.
- Experience preparing clinical regulatory documents in a clinical setting, pharma, or CRO.
Skills:
- Analytical/statistical aptitude; clinical knowledge; editing; project/process management; quality review; strategic thinking; technical learning; priority setting; problem solving.
Benefits/Compensation (explicit):
- Remote; base salary $106,000–$176,600; bonus target 15%; eligible for long-term incentives; 401(k) match, retirement contribution, paid vacation/holidays/personal days, paid caregiver/parental and medical leave, medical/dental/vision.
- Independently perform document quality review (DQR) of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses); document and escalate significant findings.
- Participate in resolution of findings with authors, clinicians, and team members.
- Manage DQR document archival processes.
- Produce style guides, manuals, and quality review work guides; coordinate style agreement across projects.
- Lead/manage complex tasks; communicate initial findings.
- Analyze DQR findings to identify root causes; participate in corrective action planning; compile/analyze data quality metrics.
- Serve as SME for DQR/QC; lead quality activities and set standards for collaboration, commitments, and customer satisfaction.
- Participate on project teams/task forces; recommend cross-process improvements and streamline routine processes.
Qualifications:
- BS/BA degree (preferably English/journalism/communications or biological science).
- 7+ years of experience in medical writing and/or DQR/QC of clinical documents in pharma/healthcare.
- Strong scientific understanding; medical terminology knowledge; familiarity with the AMA Manual.
- Required: ability to edit for clarity; strong verbal/written/interpersonal skills; rigorous attention to detail while working rapidly/accurately.
Preferred:
- Advanced degree in relevant medical editing/document quality review.
- Experience preparing clinical regulatory documents in a clinical setting, pharma, or CRO.
Skills:
- Analytical/statistical aptitude; clinical knowledge; editing; project/process management; quality review; strategic thinking; technical learning; priority setting; problem solving.
Benefits/Compensation (explicit):
- Remote; base salary $106,000–$176,600; bonus target 15%; eligible for long-term incentives; 401(k) match, retirement contribution, paid vacation/holidays/personal days, paid caregiver/parental and medical leave, medical/dental/vision.