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Controlled Docs Sr Coordinator

2+ years
Not Disclosed
10 March 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Controlled Docs Sr Coordinator

Category: Regulatory/Compliance
Location: Bangalore, India
Job Type: Full-Time (Onsite)

Position Overview:

Labcorp is seeking a Controlled Docs Sr Coordinator to manage controlled document administration, ensure regulatory compliance, and support quality assurance processes.

Key Responsibilities:

  • Document Administration & Compliance:

    • Administer controlled documents and ensure availability to end users.
    • Follow applicable Standard Operating Procedures (SOPs) and Work Instructions.
    • Ensure regulatory compliance and quality assurance as per controlled documents.
    • Complete required training within set timelines.
  • Quality Control & Reporting:

    • Perform quality checks to ensure accuracy and compliance.
    • Track and report key performance metrics to management.
    • Escalate issues impacting document release and manage resolutions.
  • Process Improvement & Collaboration:

    • Assist in implementing new/revised processes and procedures.
    • Collaborate with cross-functional teams to ensure smooth documentation flow.
    • Support ad hoc tasks as assigned by management.

Qualifications & Experience:

  • Education:

    • Associate degree recommended (experience may be substituted for education).
  • Experience & Skills:

    • 2+ years of experience in a regulatory environment (GxP roles preferred).
    • Strong analytical, organizational, and communication skills.
    • Attention to detail and ability to deliver high-quality work consistently.
    • Proficiency in computer applications and departmental tools.

Working Conditions:

  • Tasks involve prolonged computer usage.
  • Some overtime and weekend work may be required.

Labcorp is an Equal Opportunity Employer committed to diversity, inclusion, and fair hiring practices.