Senior Principal Medical Writer

Syneos Health, Inc.; Location (WV); Remote; USD 114,000 - 211,000; Full time

Job summary

A leading biopharmaceutical solutions organization seeks a Senior Principal Medical Writer to develop and manage regulatory documents, mentor junior writers, and ensure compliance with industry standards. This remote position offers a competitive salary range of $114,000 to $210,900 and comprehensive benefits including health, retirement plans, and paid time off.

Benefits

Health benefits (medical, dental, vision)

401(k) with company match

Employee Stock Purchase Plan

Flexible PTO/sick time

Qualifications

• 5+ years of experience in medical writing in the biopharmaceutical industry.
• Strong understanding of ICH guidelines and regulatory submissions.
• Proven track record of producing high-quality clinical documents.

Responsibilities

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

Skills

Medical writing

Regulatory compliance

Mentoring

Project management

Education

Relevant degree in life sciences

Job description

Updated: September 24, 2025
Location: USA-WV-Remote
Job ID:25101798

Overview

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 on the customer and the patient. 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

• We invest in people through career development, training, and total rewards programs.
• We foster a Total Self culture where you can authentically be yourself and feel you belong.

Job Description

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. We provide strategic direction to cross-functional teams to ensure clinical documents (eg, IBs, CSRs, and submission documents) are rigorous, well-structured, and compliant with regulatory requirements.

Role includes leadership of medical writing activities across multiple compounds, mentoring junior writers, and ensuring timely delivery of high-quality documents. The position involves collaboration with cross-functional teams, development of regulatory documents in line with ICH and global guidelines, and contribution to process improvements and SOPs.

Responsibilities

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

Benefits and Salary

The benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), 401(k) with company match, eligibility to participate in the Employee Stock Purchase Plan, potential bonuses, and flexible PTO/sick time. Paid sick time eligibility may vary by location. Syneos complies with all applicable laws regarding paid time off.

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

Additional Information

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, and role proficiency.

Get to know Syneos Health

We are dedicated to building a diverse, inclusive and authentic workplace. We encourage you to apply even if your past experience doesn’t align perfectly, and consider transferable skills. Learn more about Syneos Health and visit http://www.syneoshealth.com.

Equal Opportunity

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. If you require reasonable accommodation to complete any part of the application process, contact [e-mail].