Clinical Bioanalytics Document Management Associate

1 week ago


Chennai, Tamil Nadu, India Pfizer Full time

CBx Document and Reference Material ManagementAssist 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 metricsAssign and track method validation numbers for Clinical Bioanalytics (CBx)Serves as POC and subject matter expert for GDMS, PREDICT, Adobe Acrobat and ToolboxManage 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 requestsAssist with importation documents and tracking shipmentsAssist in creation of appropriate Job Aids.

EDUCATIONB.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 QUALIFICATIONSDetail 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 PowerPointPREFERRED 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:

FlexibleWork Location Assignment:

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

Medical#LI-PFE

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