Medical Writer II/ Sr Medical Writer

Updated: Today Location: Morrisville, NC, United States Job ID: 25109024-OTHLOC-1500-2DMO-2DR Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Job Responsibilities Job Summary Senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents while serving as the primary technical contact with the internal team and the client. Core Responsibilities Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. Completes a variety of documents including clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety updates, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters and presentations for scientific meetings. Adheres to established regulatory standards, including ICH E3 guidelines, and company standard operating procedures, client standards, and approved templates, authorship requirements, style and formatting guides, completing projects on time and on budget. Coordinates quality and editorial reviews, ensures source documentation is managed appropriately, leads team document reviews, and reviews documents as needed. Acts as peer reviewer for internal team to ensure scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format and consistency, providing feedback to further define statistical output required and document needs. Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs and medical affairs to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve issues, escalating as appropriate, and provides technical support, training and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices and capabilities. Mentors and leads less experienced medical writers on complex projects, as necessary. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, works within budgeted hours, and communicates status and changes to leadership. Completes required administrative tasks within specified timeframes. Performs other work‑related duties as assigned. Minimal travel may be required (less than 25%). Qualifications 4-year bachelor’s degree in a relevant discipline with related writing experience; graduate degree preferred. 3-5 years of relevant experience in science, technical or medical writing. Experience working in the biopharmaceutical, device or contract research organization industry required. Strong understanding of FDA and ICH regulations, other regulatory guidelines and good publication practices. Experience writing relevant document types required. Extensive knowledge of English grammar and strong familiarity with AMA Manual of Style. Benefits Benefits may include a company car or car allowance, health benefits (medical, dental, vision), company 401(k) match, eligibility to participate in an employee stock purchase plan, commissions/bonuses based on performance, and flexible paid time off. The company complies with all applicable federal, state and municipal paid sick time requirements. Salary Range $70,100.00 – $145,000.00 (Base salary range; actual will vary based on qualifications.) We are committed to equal opportunity employment. The company complies with the Americans with Disabilities Act and all relevant equal‑employment‑opportunity laws. #J-18808-Ljbffr Syneos Health Inc