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hace 2 semanas
Principal Medical Writer - Regulatory Submission Documents Updated: December 3, 2025Location: Madrid, Spain Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model centers on the customer and the patient, simplifying and streamlining work to make us both easier to work with and easier to work for. In either a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. Our 29,000 employees across 110 countries share a culture of passion, diversity, and belonging, where your work directly impacts lives worldwide. Job Responsibilities Lead clear and accurate completion of medical writing deliverables, ensuring scientific information is presented precisely. Manage medical writing activities for individual studies, coordinating across departments with minimal supervision. Produce documents such as 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. Adhere to regulatory standards (ICH E3, company SOPs, client standards) and approved style and formatting guides. Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately and documents meet scientific and formatting consistency. Act as peer reviewer to ensure clarity, consistency, and proper format. Review statistical analysis plans and table/figure specifications for content, grammar, and format. Collaborate with clients, data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables. Conduct online clinical literature searches, complying with copyright requirements. Provide technical support, training, and consultation to department and company staff. Mentor less experienced medical writers on complex projects. Develop deep expertise in key topics and regulatory requirements. Work within budget specifications for assigned projects. Qualifications Bachelor's degree in a relevant discipline; graduate degree preferred. 3–5 years of relevant experience in science, technical, or medical writing. Experience in biopharmaceutical, device, or CRO industry required. Strong understanding of FDA and ICH regulations and publication practices. Experience writing relevant document types (protocols, reports, submissions). Extensive knowledge of English grammar and strong familiarity with AMA Manual of Style. Necessary Skills Strong presentation, proofreading, collaborative, and interpersonal skills. Strong project and time management skills. Strong proficiency in MS Office. Strong understanding of medical terminology, clinical research principles, and presentation of complex data. Benefits The benefits for this position may include a company car or car allowance, health benefits (Medical, Dental, Vision), a 401(k) company match, eligibility to participate in Employee Stock Purchase Plan, commission/bonus based on performance, and flexible paid time off (PTO) and sick time. Salary Range $80,600.00 - $145,000.00 Additional Information Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and education will also be considered. The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate. Company Overview Over 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. Our culture values diversity, equity, and inclusion, and we support a diverse, equitable, and inclusive environment. #J-18808-Ljbffr
