Overview
Principal Medical Writer at 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 experience, with agile, cross-functional collaboration to accelerate the delivery of therapies.
Discover what our 29,000 employees across 110 countries already know : WORK HERE MATTERS EVERYWHERE .
Get to know Syneos Health
- We are passionate about developing our people through career development, training, peer recognition, and total rewards.
- We foster a Total Self culture and strive to take care of our people.
- We value diversity of thought and perspectives to create a sense of belonging.
Job Responsibilities
Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.Manage medical writing activities for individual studies, coordinating these activities within and across departments with minimal supervision.Prepare 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 regulatory standards, including ICH E3 guidelines, SOPs, client standards, templates, and style guides.Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.Act as a peer reviewer to ensure scientific content, clarity, consistency, and proper formatting.Review statistical analysis plans and table / figure / listing specifications for content, grammar, format, and consistency; provide feedback to define statistical output requirements.Interact with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.Perform online clinical literature searches and comply with copyright requirements.Identify and propose solutions, providing technical support, training, and consultation to department and company staff.Mentor and lead less experienced medical writers on complex projects.Develop deep expertise on key industry topics and regulatory requirements.Work within budget specifications for assigned projects.Qualifications
Bachelor's degree in a relevant discipline with writing experience; graduate degree preferred.3–5 years of relevant experience in science, technical, or medical writing.Experience in the biopharmaceutical, device, or contract research organization industry is required.Strong understanding of FDA and ICH regulations, other regulatory guidelines, and / or good publication practices.Extensive knowledge of English grammar and ability to communicate clearly; familiarity with AMA Manual of Style.Necessary Skills
Strong presentation, proofreading, collaborative, and interpersonal skills.Strong project and time management skills.Proficiency in MS Office.Strong understanding of medical terminology, clinical research principles, and the ability to interpret and present complex data.Additional Information
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 your role, you’ll take initiative and challenge the status quo in a highly competitive environment.
Syneos Health is an 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 reasonable accommodations, contact us at : jobs@syneoshealth.com.
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. This includes summaries from raw data for regulatory submissions or in-company use, monographs, reviews, scientific exhibits, and other projects requiring medical communication skills. The role involves screening, analyzing, and summarizing data from other sources, conducting literature searches, preparing literature for new products, and revising existing medical communications. These roles 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 to health authority questions. They may lead entire projects within their area of responsibility and are expected to work with cross-functional teams to deliver high-quality medical writing deliverables.
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