Principal Medical Writer - REMOTE

About the position This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Medical Writer - REMOTE. In this role, you will contribute to the production of regulatory documentation essential for the international pharmaceutical industry. Your expertise in Chemistry, Manufacturing, and Controls (CMC) will drive the creation of compliant CMC dossiers. By interpreting technical data and leading a team of writers, you will enhance the quality and effectiveness of regulatory submissions. This position also involves supporting the development of AI solutions for medical writing, ensuring innovation and efficiency in our processes. As a fully remote position, you will have the flexibility to achieve impactful results from anywhere. Responsibilities • Write, edit, and review complex CMC regulatory documents including Module 3 of the eCTD. • Interpret and summarize technical data from analytical development and manufacturing. • Ensure all documents adhere to ICH, FDA, and EMA regulations. • Drive the development of CMC outputs and collaborate with the AI development team. • Lead cross-functional CMC writing teams to integrate inputs from diverse departments. • Perform rigorous peer reviews and final quality checks on documentation. • Provide guidance, training, and mentorship to junior medical writers. Requirements • 5–10+ years of experience in medical writing with a focus on CMC regulatory documentation. • Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline. • Deep understanding of ICH Guidelines for Module 3. • Excellent written and oral communication skills. • Strong project management capabilities for handling multiple complex projects. • Expert knowledge of Microsoft Office Suite and Electronic Document Management Systems. Benefits • Competitive base salary. • Annual bonus opportunity. • Generous paid time off allowance. • Extended healthcare plan and additional insurance coverages. • Retirement savings plan with company match. • Full membership to AMWA and paid conference attendance. • Opportunities for personal and professional development. • Free weekly yoga sessions. • Engaging team events for bonding and development. Apply tot his job

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