Pfizer

Manager, Document Quality Reviewer

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
June 10 2021
Ref
4814218
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
JOB SUMMARY

The role manages and conducts quality reviews to support delivery of accurate, compliant clinical submission documents and publications prepared by authors in Vaccine Clinical Research and Development and other partner lines. Documents include (but are not limited to) protocols, components of clinical study reports, statistical analysis plans, briefing documents, and regulatory responses.

JOB RESPONSIBILITIES
  • With minimal supervision, perform document quality review and participate in quality projects in accordance with agreed-upon timelines.
  • Verify accuracy of document content using source documents, including clinical regulatory documents (e.g., protocols, clinical study reports, CIOMS reports, clinical summaries/overviews) and data tables, figures, and listings.
  • Verify consistency of data and information within a document and across related documents.
  • Perform editorial review of documents.
  • Verify uniformity and compliance of documents with internal and external standards (e.g., document templates, company and project style guides).
  • Record observations and collaborate with the document author and other team members to resolve them.
  • Identify, communicate, and resolve issues that may impact document timelines.
  • Recommend process improvements that could reduce recurring errors in documents.
  • Participate in quality processes and process improvement initiatives.
  • Contribute to the training of colleagues on quality standards and processes.


QUALIFICATIONS / SKILLS
  • At minimum Bachelor degree, preferably in a life science or communications discipline. Advanced degree preferred.
  • BS/BA +5 years, MS/MA +3 years of experience in document QC and/or medical writing in the pharmaceutical or biotech industry.
  • Ability to work with minimal supervision. Ability to work well under pressure and adapt to change as needed.
  • General understanding of medical terminology, clinical trials, and drug development process.
  • Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
  • High degree of fluency in written and spoken English.
  • Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships.
  • Proficiency with computer applications (e.g., Adobe Acrobat, MS Word, MS Excel, MS PowerPoint).
  • #Li-PFE
  • Other Job Details
  • Eligible for Employee Referral Program


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The position occasionally necessitates work beyond regular hours, which includes 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.

Medical

Similar jobs

Similar jobs