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Medical Writer Group Lead

8-12 years
Not Disclosed
10 June 27, 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

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Medical Writer Group Lead – Clinical & Regulatory | Mysore, Karnataka

Job Summary:
Join a high-impact role as a Medical Writer Group Lead specializing in drug safety and clinical trial documentation. Based in Mysore, this full-time position is ideal for experienced medical writers with 8–12 years of background in CRO or pharma environments. You will oversee the development of high-quality documents such as CSRs, Patient Narratives, IBs, Protocols, and regulatory submissions, collaborating with global clients and internal teams to ensure timely and compliant deliverables.


Key Responsibilities:

  • Prepare and review a broad range of clinical and regulatory documents per ICH-GCP and sponsor standards

  • Author high-quality scientific content including:

    • Clinical Study Reports (CSRs)

    • Patient Safety Narratives

    • Investigator’s Brochures (IBs)

    • Clinical Study Protocols and Amendments

    • Protocol Synopses and Clinical Trial Summaries

  • Interpret and synthesize clinical data from statistical outputs (tables, listings, figures)

  • Work cross-functionally with clinical, biostatistics, PV, and project management teams

  • Serve as point of contact for sponsor communication, feedback incorporation, and quality assurance

  • Ensure version control, document accuracy, and on-time submission to meet global regulatory requirements


Required Skills & Qualifications:

  • Bachelor’s, Master’s, or PhD in Life Sciences, Pharmacy, Medicine, or a related field

  • 8–12 years of hands-on medical writing experience in a CRO or pharma setting

  • In-depth knowledge of ICH-GCP guidelines and international regulatory requirements

  • Proficiency in MS Word, Excel, PowerPoint, and document management systems

  • Strong command of English with excellent written and verbal communication skills

  • Effective multitasking, organizational, and leadership abilities


Preferred Qualifications:

  • Experience with eCTD submissions and regulatory agency interactions

  • Therapeutic area knowledge in oncology, CNS, cardiovascular, or rare diseases

  • Familiarity with Adobe Acrobat Pro and referencing software tools


Perks & Benefits:

  • Competitive industry-aligned compensation

  • Leadership opportunities in high-visibility global projects

  • Collaborative work environment in a CRO setting

  • Exposure to end-to-end clinical trial lifecycle documentation

  • Access to global clients and cutting-edge drug development


Company Overview:

Our client is a globally recognized Clinical Research Organization (CRO) specializing in regulatory medical writing and drug safety services. With a strong presence in India, the organization supports life sciences companies through accurate, compliant, and timely clinical documentation that meets international regulatory standards. Their mission is to advance healthcare outcomes through science-driven content excellence.


Work Mode: On-site | Location: Mysore, Karnataka


Apply Now

Are you an experienced medical writer ready to lead? Apply today and contribute to global healthcare innovations by delivering high-impact clinical and regulatory documentation.