Clinical Bioanalytics Document Management Associate
Year Chennai, Tamil Nadu, India
Job Description
b'
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
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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Job Detail
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Job IdJD3324846
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationChennai, Tamil Nadu, India
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EducationNot mentioned
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ExperienceYear