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Manager - Report Writing

0-1 years
₹12,00,000 – ₹16,00,000 per annum
10 Oct. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Manager – Report Writing

Req ID: 1403
Date Posted: October 8, 2025
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: ₹12,00,000 – ₹16,00,000 per annum


🏢 About Lambda Therapeutic Research

Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India.
With facilities and operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland) — Lambda provides end-to-end clinical research solutions to global innovator, biotech, and generic pharmaceutical industries.


🎯 Job Responsibilities

  • Authoring & Reviewing Documents:
    Prepare and review Clinical Study Reports (CSRs) for clinical trials (Phase II, III, and IV).

  • Protocol & Data Review:
    Review eCRFs (electronic Case Report Forms) and Statistical Analysis Plans (SAPs) from a medical writing perspective.

  • Data Evaluation:
    Review medical coding, data listings, and summary results to ensure accuracy and consistency.

  • Regulatory Documentation:
    Draft Clinical Modules and related documents for regulatory submissions.

  • Training:
    Conduct medical writing and CSR-related trainings for project teams.


🧾 Key Deliverables

  • Clinical Study Reports (Phase II–IV)

  • Clinical Modules for Regulatory Submissions

  • Responses to Regulatory Queries


🎓 Education

  • Qualification: MD in Pharmacology


💼 Experience

  • Required: 0–1 year of experience in Clinical Study Report (CSR) writing for late-phase projects

  • Preferred: Exposure or training in:

    • Medical Writing

    • CSR Writing

    • Literature Search and Review


🌍 Organizational Type

Global Clinical Research Organization (CRO) providing comprehensive clinical research services across multiple international locations.