Senior Manager, Document Quality Reviewer, Vaccines

Pfizer • Collegeville, PA

4d • $106,000 - $176,600 • Remote

About The Position

Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. What You Will Achieve 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 participate 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.

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

Nice To Haves

• 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.

Responsibilities

• 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 participate 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.

Benefits

• this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees