Senior Principle Medical Writer

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

Job summary

A leading biopharmaceutical solutions organization seeks a Senior Principal Medical Writer responsible for developing regulatory documents, managing projects, mentoring junior writers, and ensuring adherence to global standards. This role focuses on improving life through strategic documentation and cross-functional collaboration. Competitive salary range: $114,000 - $210,900. A strong background in medical writing and regulatory guidelines is essential.

Benefits

Health benefits (Medical, Dental, Vision)

401(k) with company match

Employee Stock Purchase Plan

Flexible PTO

Qualifications

• 5+ years of experience in medical writing or clinical development.
• Strong understanding of global regulatory standards.
• Ability to manage multiple projects and teams.

Responsibilities

• Develop regulatory documents for global submissions.
• Manage medical writing projects and timelines.
• Mentor junior writers on best practices.

Skills

Regulatory knowledge

Medical writing

Project management

Cross-functional collaboration

Mentorship

Education

Advanced degree in Life Sciences

Job description

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

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 places the customer and the patient at the center of everything we do. We simplify and streamline work to make Syneos Health easier to work for and with.

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 committed to changing lives.

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

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We develop our people through career development and progression; supportive 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. We are dedicated to taking care of our people.
• We foster diversity of thought, backgrounds, cultures, and perspectives to create a sense of belonging for all.

Job Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and in line with Incyte/ Syneos authoring standards, while adhering to study/project timelines and objectives.
• Manage medical writing projects, including developing timelines and coordinating with cross-functional teams 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 regulatory documents.
• Review related project documents (eg, Protocols and Statistical Analysis Plans) as appropriate.
• Contribute to cross-functional process improvement initiatives.
• Help define and write standard operating procedures and best practices for efficient, high-quality document preparation.
• Manage internal and contract medical writing resources to ensure timely project delivery.
• Mentor more junior medical writing staff.

At Syneos Health, we provide an environment where Our People can thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (Medical, Dental, Vision), 401(k) with company match, eligibility for Employee Stock Purchase Plan, eligibility for commissions/bonus, and flexible PTO and sick time. Paid sick time eligibility varies by location; Syneos complies with all 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 on the customer and patient, with a focus on simplifying and accelerating delivery of therapies.

Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with problem solvers to help customers achieve their goals. We are agile and driven to change lives.

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

• We develop our people through career development, supportive management, technical and therapeutic area training, peer recognition and total rewards.
• We uphold the Total Self culture and are committed to taking care of our people.
• We value diverse thoughts, backgrounds, and perspectives to create a sense of belonging for all.

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 objectives.
• Lead medical writing projects, coordinate timelines, and communicate with cross-functional teams to manage review cycles and expectations.
• Participate in cross-functional meetings to provide input on deliverables and processes for regulatory documents.
• Review related documents (eg, Protocols and Statistical Analysis Plans) as appropriate.
• Participate in process improvement initiatives and help define SOPs for quality document preparation.
• Manage internal and contract medical writing resources to ensure timely completion of projects.
• Mentor junior writers.

At Syneos Health, we offer an environment where Our People can thrive, with benefits such as car allowances, health benefits, 401k, employee stock purchase plan, performance-based incentives, and flexible PTO. Paid sick time requirements vary by location; we comply with all applicable laws.

Summary

The Associate Director, Principal Medical Writer I is responsible for developing clinical documents for regulatory submissions globally, providing strategic direction to cross-functional teams, and ensuring high-quality, scientifically rigorous documents. This role may oversee multiple compounds and serve as lead writer for summary documents. Mentors less experienced writers and reports to a Director of Medical Writing or above.

We are committed to building a diverse, inclusive and authentic workplace. If past experience doesn’t align perfectly, we encourage you to apply anyway. We welcome transferable skills and offer opportunities to connect via our Talent Network.

Discover what our 29,000 employees know: work here matters everywhere. We work hard and smart to deliver therapies to patients in need. For more information, visit our site or contact us.

Website: http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities listed are not exhaustive. The company may assign additional tasks as needed. Equal employment opportunity statement and disability accommodations information are included as required by law.

Summary

The Associate Director, Principal Medical Writer I is responsible for the development and strategic direction of clinical documents for regulatory submissions globally, mentoring writers, and overseeing medical writing activities for multiple compounds. Requires broad understanding of clinical research and global regulatory standards. Reports to a Director of Medical Writing or higher.

Syneos Health is an Equal Opportunity Employer. If you require reasonable accommodation to apply, please contact us at: [e-mail].