Medical Writer II (QC of Regulatory Docs)

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,