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Controlled Documents Senior 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 Documents Senior Coordinator

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

Position Overview:

Labcorp is seeking a Controlled Documents Senior Coordinator to join its Regulatory/Compliance team in Bangalore. This role ensures effective management of controlled documents while maintaining regulatory compliance and quality assurance standards.

Key Responsibilities:

  • Follow Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Complete mandatory training within required timelines.
  • Manage controlled document administration and ensure availability to end users.
  • Track and report key metrics as per management requirements.
  • Assist in implementing new/revised processes and procedures.
  • Perform quality checks to maintain high standards of documentation.
  • Escalate and resolve issues impacting controlled document release.
  • Ensure compliance with regulatory and quality assurance responsibilities.
  • Perform additional duties as assigned by management.

Education & Experience Requirements:

  • Recommended: Associate degree (Experience may be substituted for education).
  • Experience: Minimum 2 years in a regulatory environment (GxP roles preferred).

Skills & Competencies:

  • Strong planning, organization, and communication skills.
  • Excellent attention to detail and analytical abilities.
  • Strong interpersonal skills and ability to work collaboratively.
  • Consistently deliver high-quality work.
  • Proficiency in using computers and departmental tools.

Working Conditions:

  • Prolonged screen time working on a computer.
  • May require overtime and weekend work.

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