Sr Medical Writer (Regulatory Documents)

Syneos Health, Inc.; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Medical Writer to manage the preparation of critical regulatory documents. The ideal candidate will have 3-5 years of experience in medical writing and a strong knowledge of FDA regulations. Responsibilities include leading the completion of medical writing deliverables and mentoring less experienced writers. This position is fully remote, offering competitive compensation and growth opportunities.

Qualifications

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

Responsibilities

• Lead and complete medical writing deliverables accurately.
• Prepare various regulatory documents and journals.
• Coordinate quality and editorial reviews.

Skills

Presentation skills

Proofreading

Collaboration

Interpersonal skills

Project management

Time management

MS Office proficiency

Education

Bachelor's degree in a relevant discipline

Graduate degree preferred

Job description

Overview

Sr Medical Writer (Regulatory Documents)

Updated: September 29, 2025 • Location: USA-OR-Remote • Job ID: 25101802

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. We collaborate across the organization to accelerate delivery of therapies and improve patients’ lives.

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
• 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 (ICH E3, SOPs, client standards, templates, authorship requirements, and style guides)
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
• Act as a peer reviewer for the internal team to ensure scientific content, clarity, consistency, and proper format
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency; provide feedback to define statistical outputs 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; provide technical support, training, and consultation to department and 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, medical device, or contract research organization industry
• Strong understanding of FDA and ICH regulations and good publication practices
• Experience writing the specified document types
• Excellent English grammar; familiarity with AMA Manual of Style

Necessary Skills

• Strong presentation, proofreading, collaboration, and interpersonal skills
• Strong project and time management
• Proficiency in MS Office
• Understanding of medical terminology, clinical research principles, and interpretation/presentation of clinical data

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 your role, you’ll take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health at www.syneoshealth.com.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. Equal opportunity employer information is included below.

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 to participate in the application process, please contact [e-mail].

Summary: Roles within the Medical Writing job family at the P22 level involve writing and editing manuscripts and other medical communications on clinical studies and scientific reports, conducting literature searches, and coordinating across departments to deliver compliant, high-quality documents.