Principal Medical Writer Job at Syneos Health, Inc. in Location

Overview

Principal Medical Writer – 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. Our Clinical Development model centers the customer and patient, aiming to simplify and streamline work. 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 to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

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 SOPs, client standards, and approved templates, authorship requirements, and style/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 content, grammar, format, and consistency; provide feedback to define statistical output and document needs
• Interact 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

Get to know Syneos Health

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.

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.

Additional Information

Tasks, 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.

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, including special summaries from raw data for regulatory submissions or internal use, monographs, reviews, and other projects requiring medical communication skills. They screen, analyze, and summarize additional data from other sources, conduct systematic literature searches and reviews, prepare literature for new products, and revise existing medical communications. They review and analyze statistical outputs to prepare documents such as clinical study reports and development safety update reports, and support engagement with regulatory agencies through briefing books and responses. They may be responsible for entire projects or processes within their area of responsibility.

Impact and Core Focus: Roles ensure clear and accurate medical writing deliverables, coordinate activities across departments, and manage a variety of documents while adhering to regulatory standards. Core focus areas include leading deliverables, managing activities, cross-department coordination, quality and editorial reviews, peer reviewing, reviewing analysis plans, client relations, literature searches, issue resolution, mentoring, and budgeting.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway and consider transferable skills. We also invite you to join our Talent Network to stay connected to opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart to get therapies to those who need them. A career with Syneos Health means your everyday work improves patients’ lives around the world. Syneos Health (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutions organization, and we support a diverse, equitable and inclusive culture.

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status. If you require a reasonable accommodation to participate in the application process, please contact jobs@syneoshealth.com.