Principal Med Writer in भारत

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. 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 New 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, applicable regulatory requirements, therapeutic area considerations, and industry best practices to support effective clinical and regulatory communication. - Team Leadership and Mentoring: Provide training, guidance, and mentorship to medical writers and program managers on document preparation, document types, writing tools, regulatory expectations, and therapeutic area knowledge. - Process Improvement: Develop, review, and promote best practices, methods, and techniques that improve the quality and efficiency of medical writing activities. Lead process improvement initiatives and support the implementation of client-specific procedures. - Project Performance Monitoring: Contribute to the development, review, and management of project performance metrics, helping monitor quality, productivity, and delivery against established objectives. - Program Management Support: Act as a backup program manager when required, identifying and resolving out-of-scope activities and supporting the development of project timelines, budgets, forecasts, and contract modifications. - Business Development Support: Assist with client presentations, proposal reviews, bid defense meetings, and capability presentations when needed. - Cross-Functional Collaboration: Represent the medical writing function at project kickoff meetings, document review sessions, and project team meetings, facilitating clear communication and alignment among internal and external stakeholders. - Operational Excellence: Coordinate writing activities from initial planning through final delivery, ensuring that deadlines are met and deliverables consistently satisfy client expectations. Requirements: - Scientific or Medical Background: A relevant academic background in life sciences, medicine, pharmacy, biomedical sciences, or another related scientific discipline is desirable for the role.