Medical Writer II (CSR Narratives)

As a Medical Writer II (CSR Narratives) at Syneos Health, you will have the opportunity to work in a leading fully integrated biopharmaceutical solutions organization that is committed to accelerating customer success. Your role will involve translating unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. **Key Responsibilities:** - Mentor less experienced medical writers on projects as necessary. - Compile, write, and edit medical writing deliverables with minimal supervision. - Develop or support various documents including clinical study protocols, patient narratives, annual reports, and investigator brochures. - Review statistical analysis plans and ensure appropriate content, grammar, format, and consistency. - Interact with department members to produce writing deliverables. - Serve as a peer reviewer on internal review teams and address comments accurately. - Adhere to regulatory standards and company procedures when completing medical writing projects. - Stay updated on regulatory guidance and client expectations in medical writing. - Manage budget specifications for assigned projects and communicate changes to medical writing leadership. - Perform on-line clinical literature searches as needed. - Complete required administrative tasks within specified timeframes. - Perform other work-related duties as assigned. - Minimal travel may be required (less than 25%). **Qualifications:** - Minimum 1 year of experience working with narratives with a master's qualification, or 2 years of experience with a bachelor's degree. - Postgraduate (Masters/Mpharm) or bachelor's degree. - Extensive knowledge of English grammar, FDA and ICH regulations, and AMA style guide. - Demonstrated independence with effective presentation, proofreading, interpersonal, and leadership skills. - Proficiency in Word, Excel, PowerPoint, email, and Internet. - Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information. Discover the opportunities at Syneos Health, where you can be part of a team that has worked with 94% of all Novel FDA Approved Drugs in the past 5 years and is committed to challenging the status quo in a highly competitive environment. Learn more about Syneos Health at [Syneos Health Website](http://www.syneoshealth.com).,