• Senior Manager, Document Quality Reviewer Jobs in New York City

  • Pfizer Inc.
  • New York City

Job Description:

ROLE SUMMARY

The Senior Manager, Document Quality Reviewer 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

ROLE RESPONSIBILITIES

Independently performs DQR of clinical components of assigned documents (eg, 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

BASIC QUALIFICATIONS

BS/BA degree (preferably in English/journalism/communications or biological science) An advanced degree with relevant medical editing or document quality review experience is preferred
Minimum 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 is required 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 Prior experience preparing clinical regulatory documents in a clinical setting, at a pharmaceutical company, or at a CRO is helpful

PREFERRED QUALIFICATIONS

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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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