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Narrative Medical Writer – India

2+ years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Safety Narrative Medical Writer

Responsibilities

📌 Safety Narrative Development

  • Prepare and review safety narratives for Clinical Study Reports (CSRs) and other regulatory submissions.

📌 Cross-Functional Collaboration

  • Work closely with safety, medical monitoring, and clinical operations teams to gather and interpret relevant data.

📌 Regulatory Compliance

  • Ensure all narratives adhere to international regulatory guidelines and sponsor-specific requirements.

📌 Quality & Timeliness

  • Maintain high-quality documentation standards while ensuring timely delivery under tight deadlines.

Minimum Requirements

🎓 Experience & Expertise

  • 2+ years of experience in medical writing with a focus on safety narratives.
  • Strong understanding of regulatory requirements for clinical safety reporting.

📝 Skills

  • Excellent written communication with a keen eye for detail.
  • Ability to synthesize information from multiple sources while ensuring accuracy and clarity.