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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.
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