Senior Manager, Document Quality Reviewer, Vaccines

Role Overview

• 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 DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses, etc.) independently.
• Formally document quality review findings for assigned documents.
• Identify and immediately escalate any significant findings.
• Participate in resolution of findings with the document authors, clinicians and other team members, if necessary.
• Manage DQR document archival processes and procedures.
• Independently produce style guides, manuals, and quality review work guides for Vaccine programs and documents.
• Lead and/or manage the completion of complex tasks by applying technical skills and specialized knowledge to communicate initial findings.
• Analyze DQR findings to identify root causes of errors and discrepancies and participate in corrective action planning.

Requirements

• 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.
• A thorough understanding of scientific principles, knowledge of medical terminology and familiarity with the AMA Manual.
• The ability to edit for clarity is required, as are strong verbal, written, and interpersonal communication skills.
• The ability to pay rigorous attention to detail while working rapidly and accurately.
• An advanced degree with relevant medical editing or document quality review experience is preferred.

Benefits

• Health benefits to include medical, prescription drug, dental and vision coverage.
• Paid vacation, holiday and personal days.
• Paid caregiver/parental and medical leave.
• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary.
• Relocation assistance may be available based on business needs and/or eligibility.