Principal Medical Writer
hace 2 semanas
Principal Medical Writer – Syneos Health Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. We collaborate with customers in Functional Service Provider partnerships or Full-Service environments to deliver writing deliverables that support patient outcomes. Job ResponsibilitiesLead 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 these activities within and across departments with minimal supervision. Prepare a variety of documents, including clinical study protocols, amendments, 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, abstracts, posters, and presentations for scientific meetings. Adhere to regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates, authorship requirements, and style and formatting guides. Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately. Act as a peer reviewer for the internal team to ensure scientific content, clarity, overall consistency, and proper format. Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency; provide feedback to define statistical output requirements. Interact with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables. Perform online clinical literature searches and comply with copyright requirements. Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentor and lead less experienced medical writers on complex projects. Develop deep expertise on key topics in the industry and regulatory requirements. Work within budget specifications for assigned projects. QualificationsBachelor's degree in a relevant discipline with relevant 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/or good publication practices strongly required. Experience writing relevant document types required. Extensive knowledge of English grammar and the ability to communicate clearly; strong familiarity with AMA Manual of Style. Necessary SkillsStrong presentation, proofreading, collaborative, and interpersonal skills. Strong project and time management skills. Strong proficiency in MS Office. Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information. Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. Learn more at Syneos Health:
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