Pfizer

Senior Manager, Document Quality Reviewer, Vaccines

Pfizer

full-time

Posted on:

Location Type: Remote

Location: Pennsylvania • United States

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Salary

💰 $106,000 - $176,600 per year

Job Level

Senior

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingdocument quality reviewclinical study reportsprotocolsinvestigator brochuresregulatory responsesstyle guidesquality review work guidescorrective action planningroot cause analysis
Soft Skills
attention to detailverbal communicationwritten communicationinterpersonal communicationediting for clarityproblem-solvingteam collaborationindependent workproject managementanalytical thinking