Principal Med Writer

Job description

**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. - **Medical Writing Expertise:** Demonstrated experience in medical and scientific writing, including the preparation, editing, and review of clinical study reports, study protocols, and complex clinical or regulatory documents. - **Regulatory Documentation Knowledge:** Strong familiarity with regulatory submission documents, including IBs, INDs, and MAAs, as well as applicable clinical research regulations, documentation standards, and industry best practices. - **Scientific and Therapeutic Expertise:** Ability to interpret clinical study data, synthesize complex scientific information, and communicate findings accurately and clearly to technical and non-technical audiences. - **Advanced Editing and Review Skills:** Excellent writing, editing, proofreading, and document-review capabilities, with strong attention to detail and a commitment to producing high-quality, compliant deliverables. - **Leadership and Mentoring:** Proven ability to provide technical guidance, train junior colleagues, review team deliverables, and promote consistent writing practices across projects. - **Project Coordination:** Ability to manage multiple writing assignments, coordinate stakeholders, monitor timelines, and contribute to resource planning, budgeting, and project performance tracking. - **Quality and Compliance:** Experience applying quality management processes, standard operating procedures, client-specific requirements, and regulatory guidelines throughout the document lifecycle. - **Process Improvement Mindset:** Ability to identify opportunities to improve document development workflows, establish best practices, and implement practical solutions that enhance quality and operational efficiency. - **Communication and Collaboration:** Strong interpersonal and communication skills, with the ability to work effectively with clients, program managers, clinical teams, and other cross-functional stakeholders. - **Organization and Problem-Solving:** Excellent planning, analytical, and problem-solving skills, with the ability to prioritize competing deadlines and resolve complex documentation challenges. - **Adaptability and Accountability:** Ability to work independently, exercise sound professional judgment, and maintain high standards of accuracy and accountability in a deadline-driven environment. - **Program Management Flexibility:** Willingness and ability to provide backup program management support, including participation in client meetings, proposal development, and project planning activities when required. ## Benefits: - **Fully Remote Work:** Work remotely from India, offering flexibility in your working environment. - **Full-Time Employment:** A full-time position with a standard Monday-to-Friday work schedule. - **Career Development:** Opportunities to deepen your medical writing expertise and expand your knowledge of clinical research and regulatory documentation. - **Leadership Opportunities:** Take on a senior role involving document ownership, technical review, mentoring, and guidance for other professionals. - **Scientific Impact:** Contribute to clinical development programs through the preparation of high-quality scientific documents that support research and regulatory activities. - **Global Collaboration:** Work with multidisciplinary teams and internal and external stakeholders across clinical research projects. - **Continuous Improvement:** Participate in initiatives that strengthen document quality, optimize processes, and improve operational performance.