[Hiring] Senior Manager, Document Quality Reviewer @Pfizer

Role Description

As a Senior Manager, Document Quality Reviewer , you will manage projects and conduct document quality review (DQR) on the clinical components of documents authored by Vaccine Clinical Research (VCR) across VCR global sites. DQR includes:

• Clinical data checking/consistency checking
• Clinical editing
• Checking for uniformity and compliance with Pfizer and clinical guidelines

Day-to-day goals and priorities are guided by Vaccine Clinical Research objectives and priorities.

How You Will Achieve It:

• Independently performs DQR of clinical components of assigned documents (e.g., protocols, clinical study reports, investigator brochures, manuscripts, summary documents, regulatory responses, etc.).
• Formally documents quality review findings for assigned documents.
• Identifies and immediately escalates any significant findings.
• Participates in resolution of findings with the document authors, clinicians, and other team members, if necessary.
• Manages DQR document archival processes and procedures.
• Independently produces style guides, manuals, and quality review work guides for Vaccine programs and documents, coordinating agreement on style issues within and across projects.
• Leads and/or manages the completion of complex tasks by applying technical skills and specialized knowledge to communicate initial findings.
• Analyzes DQR findings to identify root causes of errors and discrepancies and participates in corrective action planning.
• Leads the compilation and analysis of data quality metrics to ensure consistency of reviews.
• As Subject Matter Expert (SME) of DQR/QC of clinical documents, leads quality activities, setting the standard for enhanced collaboration, delivery of project commitments, and customer satisfaction.
• Participates on project teams, task forces, and/or working groups and develops recommendations for cross-Pfizer processes to ensure alignment with quality goals and other groups performing the same function.
• Evaluates routine processes and procedures to identify areas that can be eliminated or streamlined.
• Makes recommendations on process improvements that could reduce recurring errors in documents.

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.
• 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, and the ability to pay rigorous attention to detail while working rapidly and accurately.

Requirements

• An advanced degree with relevant medical editing or document quality review experience is preferred.
• Prior experience preparing clinical regulatory documents in a clinical setting, at a pharmaceutical company, or at a CRO is 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

Benefits

• Annual base salary ranges from $106,000.00 to $176,600.00.
• Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary.
• Eligibility to participate in our share-based long-term incentive program.
• Comprehensive and generous benefits including:
• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage

Work Location

• Assignment: Remote
• Work schedule is a 40-hour week during core business hours, Monday through Friday.
• Project priorities occasionally necessitate work beyond regular work hours, including evenings and weekends.