This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Principal Medical Writer based in India (Fully Remote).

As a Principal Medical Writer, you will lead the development of high-quality clinical and scientific documents that support clinical research and regulatory submissions. You will take ownership of complex writing projects, ensuring that documentation meets scientific, regulatory, and quality standards. Working closely with internal teams and external stakeholders, you will provide strategic guidance on document development, therapeutic area requirements, and industry best practices. You will also review critical deliverables, mentor junior medical writers, and contribute to continuous improvement initiatives. This role offers the opportunity to apply your scientific expertise to meaningful clinical development programs while collaborating with multidisciplinary teams. You may also support program management activities, helping ensure projects are delivered efficiently, on schedule,



and in line with client expectations.

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Accountabilities:

• Medical and Scientific Writing: Research, write, edit, and develop clinical study reports, clinical study protocols, and scientific summaries of clinical trial data, ensuring accuracy, clarity, and consistency.

• Complex Regulatory Documentation: Serve as the primary author and provide expert input on complex clinical, scientific, and program-level documents, including Investigator's Brochures (IBs), Investigational Recent Drug applications (INDs), and Marketing Authorization Applications (MAAs).

• Document Review and Quality Assurance: Conduct senior-level reviews of routine and complex documents, ensuring scientific accuracy, regulatory compliance, consistency, and adherence to established quality standards and project requirements.

• Strategic Document Development: Advise project teams and clients on document development strategies, appl

📌 Principal Med Writer (India)
🏢 Jobgether
📍 India