Principal Medical Writer

Principal Medical Writer - Regulatory Submission Documents Be among the first 25 applicants. 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 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. Whether 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. Why 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. We 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. We continuously build the company we all want to work for and the customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures and perspectives, we create a place where everyone feels like they belong. 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 these activities within and across departments with minimal supervision. Complete 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 established regulatory standards, including ICH E3 guidelines, company standard operating procedures, 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 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, providing feedback to further define statistical output required 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, 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. Qualifications Bachelor'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 ability to communicate clearly; 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, principles of clinical research and how to interpret and present clinical data and other complex information. Benefits The benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state and municipal paid sick time requirements. Salary Range $80,600.00 – $145,000.00. Additional Information Tasks, duties and responsibilities listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties and job responsibilities. Equivalent experience, skills and/or education will also be considered so qualifications of incumbents may differ. The Company is committed to compliance with the Americans with Disabilities Act and to provide reasonable accommodations when appropriate. Summary Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. The role involves screening, analyzing and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products and revising existing medical communication. These roles review and analyze statistical outputs to prepare results‑based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. #J-18808-Ljbffr