Pfizer

CBx Document and Reference Material Management

• Assist business integration activities by effectively overseeing and providing operational support to manage, migrate and file documents in appropriate document management systems/repositories.
• Supports formatting and QC review for Scientific Operation (SciOps) Team maintained controlled documents.
• Support QC effort to ensure Bioanalytical Method Validation, Study Reports and related documents adhere to Pfizer and regulatory submission-ready requirements.
• Follow internal best practices, processes consistently and ensure that report quality meets Pfizer standards, strategy, and assay life cycle management requirement.
• Import submission-ready documents into document management system/repository.
• Provides document and process management support performing bioanalytical report information entry into CTS.
• Track report/document completeness/status using clinical tracking system (CTS).
• Maintain and monitor final report metrics
• Assign and track method validation numbers for Clinical Bioanalytics (CBx)
• Serves as POC and subject matter expert for GDMS, PREDICT, Adobe Acrobat and Toolbox
• Manage reference standard ordering and inventory tracking for active small molecule programs.
• Track recertification status and update COAs in Pfizer systems.
• Coordinate reference standard reloads via ERS service and recertifications via third party vendor.
• Track Metabolite/ Stable Isotope Labeled Internal Standard supply and assist to fulfill synthesis/reload requests
• Assist with importation documents and tracking shipments
• Assist in creation of appropriate Job Aids.

EDUCATION

B.S. degree with a minimum of 5 years or Masters degree with a minimum of 3 year experience in Pharma or CRO or Sourcing Group(s).

BASIC QUALIFICATIONS

• Detail oriented and possessing strong verbal, written and presentation skills. 
• Proven ability to effectively multitask and work in a highly matrixed environment.
• Highly proficient in using MS Word, Excel and PowerPoint

PREFERRED QUALIFICATIONS (BASED ON THE POSITION LEVEL AND REQUIRED EXPERIENCE)

• Self-driven, having strong time management skills.
• Demonstrated ability to plan, manage and support business operations.
• Ability to work independently and operate under minimal supervision.
• Exposure to drug development

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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