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Clinical Bioanalytics Document Management Associate (On site) - Pfizer

Date Posted: May 29, 2024
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Job Detail

  • Location:
    Chennai, Tamil Nadu, India
  • Company:
    Pfizer
  • Type:
    Full Time/Permanent
  • Shift:
    No
  • Career Level:
    No
  • Positions:
    No
  • Experience:
    5 Year
  • Gender:
    No Preference
  • Degree:
    Bachelors
  • Apply Before:
    Jun 28, 2024
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Job Description

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
#LI-PFE

Skills Required

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Company Overview

Pfizer
, India
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At Pfizer, we apply science and our global resources to bring treatments and therapies to people all over the globe. Every day, we work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. For mor... Read More

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