Senior Principle Medical Writer

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

Job summary

A leading biopharmaceutical solutions organization is seeking an Associate Director, Principal Medical Writer I. You will develop clinical documents for regulatory submissions, provide strategic direction, and mentor junior writers. This role involves overseeing writing activities for multiple compounds and ensuring compliance with global regulatory standards. The company offers competitive compensation and a focus on employee well-being.

Benefits

401(k) with company match

Health benefits (Medical, Dental, Vision)

Flexible PTO/sick time

Potential bonuses

Qualifications

• Experience in developing regulatory documents for global submission.
• Understanding of ICH and global guidelines.
• Experience in managing medical writing projects.

Responsibilities

• Develop regulatory documents in line with global guidelines.
• Manage medical writing projects and timelines.
• Participate in cross-functional meetings for deliverables.

Job description

Overview

Updated: September 16, 2025 • Location: USA-MS-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 centers the customer and the patient, with a focus on simplifying and streamlining work to make Syneos Health easier to work with and easier to work for. Whether you join in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to accelerate the delivery of therapies and change lives.

WORK HERE MATTERS EVERYWHERE

• We are committed to developing our people through career development, training, mentorship, peer recognition, and total rewards.
• We maintain a Total Self culture, supporting authenticity and well-being for our people.
• We foster a diverse, inclusive environment where everyone belongs.

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 authoring standards where applicable, adhering to study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines and coordinating with cross-functional teams to monitor review cycles and expectations.
• Participate in cross-functional meetings to provide input on medical writing deliverables, timelines, and processes for regulatory documents.
• Review related project documents (e.g., Protocols and Statistical Analysis Plans) as appropriate.
• Participate in cross-functional process improvement initiatives and in defining/writing standard operating procedures and best practices for efficient, quality documents.
• Manage internal and contract medical writing resources to ensure timely project completion.
• Mentor more junior medical writing staff.

Benefits and Compensation

At Syneos Health, we provide 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), 401(k) with company match, eligibility for Employee Stock Purchase Plan, potential bonuses, and flexible PTO/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 / 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 mentoring writers. This role oversees medical writing activities for multiple compounds and serves as lead writer for individual summary documents, with broad understanding of clinical research processes and global regulatory standards. Reports to a Director of Medical Writing or above.

Additional information: Equal opportunity employer; diversity and inclusion are fundamental to our culture. If you require accommodations during the application process, contact [e-mail].

Get to Know Syneos Health

Discover what our 29,000 employees already know: work here matters everywhere. We strive to move therapies to patients who need them most and offer a collaborative, innovative, and inclusive environment.

Website: http://www.syneoshealth.com

Additional Information

Summary statements and responsibilities are not exhaustive. The company may assign additional tasks as needed. This description reflects current requirements at the time of posting and is subject to change. We are committed to compliance with applicable laws and to providing reasonable accommodations as needed during the hiring process and employment.