Principal/Sr Medical Writer - Publications - Sponsor Dedicated - US (Central Location)

Syneos Health, Inc.; South Dakota; Remote; USD 80,000 - 145,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Principal/Sr Medical Writer. This position involves managing writing activities for clinical documents, mentoring junior writers, and ensuring compliance with FDA regulations. Ideal candidates possess a relevant degree and strong writing and leadership skills. The role is remote and offers a competitive salary of $80,600 to $145,000, depending on qualifications.

Benefits

Health benefits including Medical, Dental and Vision

Company match 401k

Employee Stock Purchase Plan

Flexible paid time off

Qualifications

• Relevant writing experience in scientific or medical fields.
• Extensive knowledge of FDA and ICH regulations.
• Ability to interpret clinical data.

Responsibilities

• Mentors less experienced medical writers.
• Manages medical writing activities.
• Develops various clinical documents.

Skills

English grammar knowledge

Presentation skills

Proofreading

Interpersonal skills

Leadership skills

Education

Bachelor of Science or Arts degree

Tools

Word

Excel

PowerPoint

Job description

Overview

Principal/Sr Medical Writer - Publications - Sponsor Dedicated - US (Central Location)

Updated: September 22, 2025
Location: USA-SD-Remote
Job ID: 25003732

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 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 is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Responsibilities

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Acts as lead for assigned writing projects.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Develops or supports a variety of documents, including but not limited to:
• Clinical study protocols and clinical protocol amendments
• Clinical study reports
• Patient narratives
• Clinical development plans
• IND submissions and annual reports
• Integrated summary reports
• NDA and (e)CTD submissions
• Investigator brochures
• Clinical journal manuscripts, clinical journal abstracts, and client presentations

• Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Interacts with department head and staff in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team providing review comments on draft and final documents.
• Adheres to regulatory standards (including ICH-E3), company SOPs, client standards, and approved templates; delivers on time and on budget.
• Performs online clinical literature searches as applicable.
• Maintains familiarity with current industry practices and regulatory requirements affecting medical writing.
• Maintains awareness of budget specifications for assigned projects, works within budgeted hours, and communicates changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines; familiarity with AMA style guide.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills; team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus, and flexible paid time off (PTO) and sick time. Syneos complies with all applicable paid sick time requirements.

Salary Range: $80,600.00 - $145,000.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.

http://www.syneoshealth.com

Additional Information

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 us at: Email: [e-mail]