Principal Medical Writer - Regulatory Submission Documents

Principal Medical Writer - Regulatory Submission DocumentsSyneos 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.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesLead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accuratelyManage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervisionComplete 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, and abstracts, posters, and presentations for scientific meetingsAdhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guidesCoordinate quality and editorial reviews, ensuring source documentation is managed appropriatelyAct as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper formatReview 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 needsInteract and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverablesPerform online clinical literature searches and comply with copyright requirementsIdentify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staffMentor and lead less experienced medical writers on complex projectsDevelop deep expertise on key topics in the industry and regulatory requirementsWork within budget specifications for assigned projectsQualifications:Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred3-5 years of relevant experience in science, technical, or medical writingExperience working in the biopharmaceutical, device, or contract research organization industry requiredStrong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly requiredExperience writing relevant document types requiredExtensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of StyleNecessary Skills:Strong presentation, proofreading, collaborative, and interpersonal skillsStrong project and time management skillsStrong proficiency in MS OfficeStrong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex informationAt Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, 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:$95,000.00 - $175,700.00The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.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.No 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 Health.http://www.syneoshealth.comAdditional InformationTasks, duties, and responsibilities as 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 from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.