Document Management Associate - Clinical Bio @ Pfizer

Job Description

Job Description

Role & responsibilities

• Assist business by 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 company and regulatory submission-ready requirements.
• Follow internal best practices, processes consistently and ensure that report quality meets company 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)
• Manage reference standard ordering and inventory tracking for active small molecule programs.
• Track recertification status and update COAs in 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.

Preferred candidate profile

• 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

The above experienced candidates can share resume: ha*****h@pf***r.com

Regards

TA team.

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