Sr Medical Writer (Regulatory Documents)

Syneos Health, Inc.; Town of Florida (NY); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Medical Writer to ensure the clear completion of regulatory documents. This role involves managing medical writing activities, with a focus on clinical study protocols and comprehensive compliance with regulatory standards. The ideal candidate will have 3-5 years of experience in medical writing within the biopharmaceutical industry. This position offers a chance to work collaboratively to impact the delivery of therapies.

Benefits

Equal Opportunity Employer

Flexible working arrangements

Qualifications

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

Responsibilities

• Lead the completion of medical writing deliverables accurately.
• Manage medical writing activities associated with individual studies.
• Complete documents like clinical study protocols and IND submissions.

Skills

Presentation skills

Proofreading skills

Collaborative skills

Interpersonal skills

Project management skills

Time management skills

Proficiency in MS Office

Understanding of medical terminology

Education

Bachelor's degree in relevant discipline

Graduate degree preferred

Job description

Sr Medical Writer (Regulatory Documents)

Updated: September 29, 2025
Location: USA-FL-Remote

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

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, and abstracts, posters, and presentations for scientific meetings
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and 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 appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
• Interact and build good working relations 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

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 and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at: Email: [e-mail]