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Quality Control Specialist (Mw) – India

1-5 years
Not Disclosed
10 Feb. 10, 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

Quality Control Specialist (Medical Writing) – India (Freelance, Part-Time)

Excelya | Freelance | Part-Time | India

Excelya, a leading Contract Research Organization (CRO), is looking for a Quality Control (QC) Specialist to review and edit clinical regulatory documents with precision and compliance. This role requires meticulous attention to detail, strong analytical skills, and expertise in medical writing guidelines to ensure accuracy, clarity, and regulatory compliance.

Key Responsibilities

  • Review and edit medical writing and clinical regulatory documents, including:
    • Clinical study protocols & amendments
    • Informed consent forms
    • Clinical study reports
    • Clinical evaluation reports
    • Common Technical Document (CTD) submissions
    • Investigator Brochures, Lay Summaries
    • Journal manuscripts, abstracts, posters, literature reviews, and presentations
  • Perform quality control (QC) activities, ensuring accuracy, consistency, and regulatory compliance.
  • Check spelling, grammar, clarity, language appropriateness, and adherence to industry guidelines.
  • Verify data accuracy across tables, figures, listings, and referenced sources.
  • Ensure internal consistency within documents and across related documents.
  • Provide documented quality review comments and collaborate with Medical Writers and team members to resolve QC findings.

Minimum Requirements

  • Bachelor’s/Master’s degree in Life Sciences or equivalent (postgraduate studies preferred).
  • 1-5 years of experience as a QC Specialist, Editor, Copyeditor, or Medical Writer in clinical regulatory documents (preferred).
  • Advanced English proficiency (written and verbal).
  • Strong knowledge of ICH regulations, CONSORT, STROBE, and PRISMA guidelines.
  • Excellent analytical skills and ability to interpret data.
  • Attention to detail, intellectual curiosity, and creativity.
  • Ability to work effectively in a team within a fast-paced, dynamic environment.

This is a great opportunity for professionals looking for a flexible, part-time freelance role in medical writing quality control with a reputable CRO.