Sr Medical Writer - Late Phase Exp + Clinical Study Reports (CSR)\nUpdated: November 7, 2025Location: BRA-RemoteJob ID: 25100072\nDescription\nSr Medical Writer - Late Phase Exp + Clinical Study Reports (CSR)\nSyneos 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.\nOur Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.\nWhether you join us in 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. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.\nDiscover what our 29,000 employees, across 110 countries already know:\nWhy Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.\nWe are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.\nWe are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Mentors and leads less experienced medical writers on complex projects, as necessary.\nActs as lead for assigned writing projects.\nManages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.\nDevelops or supports a variety of documents that include, but not limited to: Clinical study protocols and clinical protocol amendments;\nClinical study reports;\nPatient narratives;\nClinical development plans;\nIND submissions and annual reports;\nIntegrated summary reports;\nNDA and (e)CTD submissions;\nInvestigator brochures, as well as;\nClinical journal manuscripts, clinical journal abstracts, and client presentations. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.\nReviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.\nInteracts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.\nServes as peer reviewer on internal review team providing review comments on draft and final documents.\nAdheres to established regulatory standards, including but not limited to ICH‑E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on‑time and on‑budget.\nPerforms on‑line clinical literature searches, as applicable.\nMaintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.\nMaintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.\nCompletes required administrative tasks within the specified timeframes.\nPerforms other work‑related duties as assigned. Minimal travel may be required (less than 25%). Qualifications Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.\nExtensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.\nDemonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team‑oriented approach.\nStrong proficiency in Word, Excel, PowerPoint, email, and Internet.\nAbility to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health\nOver 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.\nNo matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos