Medical Writer II (Clinical Trial Transparency)

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce high-quality writing deliverables. You will also serve as a peer reviewer to ensure scientific content accuracy, clarity, overall consistency, and proper format. Adherence to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, and client standards is paramount. Your role will involve performing online clinical literature searches, maintaining a working knowledge of the drug development process and regulatory guidelines, and continuing professional development to stay informed about regulatory guidance affecting medical writing. In this role, you will be expected to work within budget specifications for assigned projects and communicate any changes to medical writing leadership promptly. Completing required administrative tasks within specified timeframes and performing other work-related duties as assigned will be part of your responsibilities. Some minimal travel may be required, typically less than 25%. To qualify for this position, you should have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications with scientific and/or medical knowledge. Proficiency in English grammar, FDA and ICH regulations, and familiarity with AMA style guide is necessary. Effective presentation, proofreading, interpersonal, and leadership skills are essential for this role, along with a team-oriented approach. If you are passionate about making a meaningful impact in the field of medical writing and are eager to contribute to the development of cutting-edge therapies, Syneos Health offers a dynamic and supportive work environment where your contributions will be valued and recognized. Join us in our mission to accelerate customer success and transform lives through innovative medical writing practices.,