Senior Principle Medical Writer

Syneos Health, Inc.; South Dakota; Remote; USD 114,000 - 211,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Senior Principal Medical Writer to develop regulatory documents and manage medical writing projects. The ideal candidate has a strong background in medical writing, with at least 5 years of experience. This role involves mentoring junior staff and ensuring adherence to regulatory guidelines. Attractive benefits and a competitive salary range from $114,000 to $210,900 are offered.

Benefits

Company car or car allowance

Health benefits (medical, dental, vision)

Company matching 401k

Flexible PTO and sick time

Qualifications

• Minimum of 5 years of experience in medical writing.
• Proven track record of developing regulatory documents.
• Strong understanding of ICH guidelines.

Responsibilities

• Develop regulatory documents for submission to regulatory agencies.
• Manage medical writing projects and timelines.
• Mentor junior medical writing staff.

Skills

Medical writing

Regulatory submission

Cross-functional collaboration

Mentoring

Education

Advanced degree in life sciences

Tools

Microsoft Office Suite

Document management systems

Job description

Overview

Updated: September 16, 2025
Location: USA-SD-Remote
Job ID:25101798

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 the patient, continually seeking to simplify and streamline work to better serve both clients and patients.

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.

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, progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards programs.
• 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 strive to build a company that customers want to work with, valuing diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging.

Job Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, while adhering to study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines with study/project teams and communicating with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes needed for the completion of regulatory documents.
• Review related documents (e.g., Protocols and Statistical Analysis Plans) as appropriate.
• Participate in cross-functional process improvement initiatives.
• Contribute to defining and writing standard operating procedures and best practices for efficient preparation of quality documents.
• Manage internal and contract medical writing resources to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Benefits and Compensation

At Syneos Health, we believe in an environment and culture in which our people can thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (medical, dental, vision), company matching 401k, eligibility for Employee Stock Purchase Plan, eligibility to earn commissions/bonus, and flexible PTO and sick time. Paid sick time eligibility varies by location; Syneos complies with applicable paid sick time requirements.

Salary Range: $114,000.00 - $210,900.00

Description

Senior Principal Medical Writer

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 the patient. We collaborate with problem solvers in a Functional Service Provider or Full-Service environment to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Additional Information

• Tasks, duties, and responsibilities are not exhaustive. The Company may assign other tasks at its sole discretion. Qualifications may differ based on equivalent experience, skills, and education. The Company will determine what constitutes equivalency with respect to qualifications described.
• The Company complies with applicable laws, including the Americans with Disabilities Act, and provides reasonable accommodations when appropriate.

Summary

The Associate Director, Principal Medical Writer I is responsible for developing clinical documents for submissions to regulatory authorities globally, providing strategic direction to cross-functional project teams, and leading writers to deliver high-quality, scientifically rigorous documents. Mentors less experienced writers and oversees medical writing activities across multiple compounds. Reports to a Director of Medical Writing or above.

Get to know Syneos Health

We are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. We also encourage joining our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart to bring therapies to patients. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Contact Phone: [phone] | Fax: [phone] | Toll-Free: 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants 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 complete any part of the application process, please contact [e-mail].