Sr Medical Writer

Join to apply for the Sr Medical Writer - Narrative Writer role at Syneos Health Description Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work so that Syneos Health is easier to work with and easier to work for. Job Responsibilities Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision. Lead the resolution of comments from the client. Complete a variety of documents including clinical study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstract, poster and presentation for scientific meetings. Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures. Deliver projects on time and on budget. Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately. Act as peer reviewer to ensure document scientific content, clarity, overall consistency and proper format. Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format and consistency. Provide feedback to further define statistical output and document needs. Interact and build good working relations with clients, department heads and peers in data management, biostatistics, regulatory affairs and medical affairs to produce writing deliverables. Perform online clinical literature searches and comply with copyright requirements. Identify and propose solutions to resolve issues, escalating as appropriate. Provide technical support, training and consultation to department and other company staff. Contribute to development of internal materials and presentations or changes to internal processes and capabilities. Mentor and lead less experienced medical writers on complex projects. Develop deep expertise on key topics in the industry and regulatory requirements that affect medical writing. Aware of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership. Complete required administrative tasks within specified timeframes. Perform other work‑related duties as assigned. Minimal travel may be required (less than 25%). Qualifications 3–5 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry is required. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices. Experience writing relevant document types such as protocols, reports, summaries, and submissions. Extensive knowledge of English grammar and strong familiarity with AMA Manual of Style. Benefits Development and progression opportunities with supportive line management and total rewards program. Inclusive culture that values diversity of thought, background, culture and perspective. Competitive compensation and benefits package. Opportunity to work with a global team across 110 countries. #J-18808-Ljbffr