Principal Medical Writer

Syneos Health, Inc.; New Mexico; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Principal Medical Writer to lead the clear and accurate completion of medical writing deliverables. With a focus on collaboration and adherence to regulatory standards, the role encompasses managing writing activities and producing essential documents for clinical studies. A Bachelor’s degree and significant writing experience within the biopharmaceutical field are required. The position is remote, offering the opportunity to contribute to impactful healthcare outcomes.

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience in biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations.

Responsibilities

• Lead medical writing deliverables ensuring clarity and accuracy.
• Manage medical writing activities across departments.
• Produce various regulatory documents including protocols and reports.

Skills

Strong presentation skills

Proofreading abilities

Collaboration skills

Project management skills

Time management skills

Education

Bachelor’s degree in a relevant discipline

Graduate degree preferred

Tools

MS Office

Job description

Overview

Principal Medical Writer at Syneos Health. 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 centers on the customer and patient, with a focus on simplifying and streamlining work to improve the experience for both clients and employees. Whether in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with problem solvers to accelerate the delivery of therapies and contribute to changing lives.

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, support from line management, technical and therapeutic area training, peer recognition, and total rewards programs.
• We are committed to our Total Self culture – authentic participation and care for our people.
• We foster diversity of thought, backgrounds, cultures, 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 associated with individual studies, coordinating these activities within and across departments with minimal supervision
• Produce 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 (ICH E3), SOPs, client standards, approved templates, authorship requirements, and style guidelines
• Coordinate quality and editorial reviews and ensure source documentation is managed appropriately
• Act as a peer reviewer to ensure scientific content, clarity, consistency, and formatting
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency; provide feedback to define statistical output 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; provide technical support, training, and consultation to 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 writing experience; graduate degree preferred
• 3-5 years of relevant experience in science, technical, or medical writing
• Experience in biopharmaceutical, device, or contract research organization industry required
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
• Extensive knowledge of English grammar and clear communication; familiarity with AMA Manual of Style

Necessary Skills

• Strong presentation, proofreading, collaboration, and interpersonal skills
• Strong project and time management skills
• Proficiency in MS Office
• Strong understanding of medical terminology and clinical research, with ability to interpret and present complex data

Additional Information

Summary: Roles within the Medical Writing family at the P22 level involve writing and editing manuscripts and other medical communications for clinical studies and scientific reports, including data-derived summaries for regulatory submission or internal use, literature reviews, and evidence compilations. These roles review and analyze statistical outputs to prepare results-based documents and may engage with regulatory agencies through briefing books and responses to health authority questions. Core Focus includes leading the completion of medical writing deliverables, coordinating activities, and mentoring other writers. Core Focus items also include collaboration with cross-functional teams, adherence to regulatory standards, and maintaining budgets.

Office: Remote/USA-NM is reflected in the listing. Phone: [phone]; Fax: [phone]; Toll-Free: 866 462 7373.

Equal Opportunity Statement

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 a reasonable accommodation to participate in the application process, contact [e-mail].