Principal Medical Writer

Syneos Health, Inc.; New Hampshire; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Medical Writer to lead and manage medical writing deliverables across studies. This role requires a Bachelor's degree with 3-5 years of relevant experience in medical writing. The ideal candidate will have strong knowledge of FDA and ICH regulations and be able to produce clear and accurate documents. This is an exciting opportunity to impact patient outcomes through effective communication and collaboration.

Qualifications

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

Responsibilities

• Lead the accurate completion of medical writing deliverables.
• Manage medical writing activities across studies.
• Complete various clinical documents and ensure clarity and accuracy.

Skills

Presentation skills

Proofreading skills

Collaborative skills

Interpersonal skills

Project management skills

Time management skills

MS Office proficiency

Medical terminology understanding

Education

Bachelor's degree in a relevant discipline

Graduate degree

Job description

Overview

Updated: September 25, 2025

Location: USA-NH-Remote

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 puts the customer and the patient at the center of everything we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers 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.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
• We believe diversity of thoughts, backgrounds, cultures, and perspectives helps everyone belong.

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

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 at http://www.syneoshealth.com.

Additional information: Tasks, duties, and responsibilities are not exhaustive. The Company may assign other tasks at its discretion. The Company will determine what constitutes as equivalent qualifications. This description is not a contract, and nothing herein should be construed to create an employment contract. The Company is an Equal Opportunity Employer and provides reasonable accommodations for applicants with disabilities.

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 internal use, monographs, reviews, and other projects requiring medical communication skills. They support regulatory engagement and may manage entire projects within their area of responsibility.