Senior Medical Writer

As a Senior Medical Writer at Syneos Health, you play a vital role in leading the clear and accurate completion of medical writing deliverables. Your responsibilities include managing medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. You will be responsible for completing various documents such as clinical study protocols, reports, patient narratives, annual reports, and more. Adhering to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards, is essential. Your role involves coordinating quality and editorial reviews, ensuring proper management of source documentation. As a peer reviewer for the internal team, you will ensure document scientific content, clarity, overall consistency, and proper format. Interacting and building good working relations with clients, department heads, and peers in various departments are crucial for producing high-quality writing deliverables. In addition to these responsibilities, you will mentor and lead less experienced medical writers on complex projects, developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects while maintaining a high level of quality is a key aspect of your role. To qualify for this position, you should have a Bachelor's degree in a relevant discipline with relevant writing experience, while a graduate degree is preferred. 4-5 years of relevant experience in a disclosure platform and strong understanding of FDA and ICH regulations are necessary. Proficiency in MS Office, strong project and time management skills, and a good grasp of medical terminology and principles of clinical research are also required for this role. At Syneos Health, you will have the opportunity to work in a dynamic and challenging environment where you can make a difference. Join us in our mission to accelerate the delivery of therapies and change lives.,