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.
- BS/BA degree (preferably in English/journalism/communications or biological science).
- 5+ 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.
- MS with at least 3 years of relevant medical editing or document quality review experience
- Prior experience preparing clinical regulatory documents in a clinical setting, at a pharmaceutical company, or at a CRO is helpful.
- Analytical skills and statistical aptitude
- Editing skills
- Project and process management
- Quality review skills
- Strategic thinking
- Technical learning
- Priority setting
- Problem solving
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.
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.