Pfizer

Senior Manager, Document Quality Reviewer

Employer
Pfizer
Location
Pearl River, New York
Salary
Competitive
Posted
April 30 2021
Ref
4807833
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
ROLE SUMMARY

The Senior Manager, Document Quality Reviewe r 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 (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.


QUALIFICATIONS

Education
At a minimum, 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.

Experience
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.

Technical Skills Requirements

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

PHYSICAL/MENTAL REQUIREMENTS

Work is performed at a desk, primarily with laptop, monitor, and keyboard.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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