Regulatory Principal Medical Writer - USA - West Coast, Canada

Syneos Health, Inc.; Missouri; Remote; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Medical Writer to mentor peers and manage writing activities for clinical studies. Candidates should possess a Bachelor's degree and strong writing skills. An understanding of FDA guidelines is a plus. This role offers competitive salaries ranging from $95,000 to $175,700 and various benefits in a remote setting.

Benefits

Company car or car allowance

Health benefits (Medical, Dental, Vision)

401(k) with company match

Employee Stock Purchase Plan eligibility

Flexible PTO

Qualifications

• Relevant writing experience or related scientific/medical knowledge required.
• Extensive knowledge of English grammar and familiarity with AMA style guide.
• Understanding of FDA and ICH regulations strongly preferred.

Responsibilities

• Mentor and lead less experienced medical writers.
• Manage medical writing activities for individual studies.
• Develop clinical documents including protocols and reports.
• Review statistical analysis plans and ensure quality.

Skills

Effective presentation skills

Proofreading skills

Interpersonal skills

Team-oriented approach

Education

Bachelor of Science or Bachelor of Arts degree

Tools

Word

Excel

PowerPoint

Email

Internet

Job description

Updated: August 29, 2025
Location: USA-MO-Remote
Job ID:25001621

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 the customer and the patient in everything we do. We continuously seek ways to simplify and streamline our work to be easier to work with and 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:

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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone belongs.

Job Responsibilities

• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Represents the Medical Writing department on clinical study teams, at conferences, meetings and for client presentations.
• Advises clients and study teams on data presentation and production strategies to meet client objectives/expectations and maintain quality standards.
• Develops good working relationships with internal and external colleagues.
• Manages medical writing activities for individual studies, coordinating across departments with minimal supervision.
• Develops or supports documents including: clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD submissions; investigator brochures; and clinical journal manuscripts, abstracts, and client presentations.
• Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Provides peer review to ensure clarity, accuracy, relevance and alignment with client objectives and quality standards.
• Adheres to regulatory standards (e.g., ICH-E3), SOPs, client standards, and approved templates; delivers on time and on budget.
• Performs online clinical literature searches as applicable.
• Maintains up-to-date professional development to align with regulatory guidance and client expectations.
• Understands budget specifications, works within budgeted hours, and communicates changes to medical writing leadership.
• Completes required administrative tasks within specified timeframes.
• Performs other duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

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

At Syneos Health, we provide an environment 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 and sick time. Paid sick time requirements vary by location; we comply with applicable laws.

Salary Range: $95,000.00 - $175,700.00

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

Get to know Syneos Health

Discover what our 29,000 employees already know: work here matters everywhere. We work hard and smart to deliver therapies to patients in need.

Equal Opportunity Employer statement available upon request. For accommodation, contact [e-mail].

Additional Information

Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks at its discretion. The company complies with applicable employment laws and supports a diverse, inclusive workplace.