Principal Medical Writer (Regulatory)

MedStar Health; Kansas; On-site; USD 95,000 - 176,000; Full time

Job summary

A leading biopharmaceutical organization is seeking a Principal Medical Writer to lead complex projects and mentor junior writers. This role involves managing medical writing activities while adhering to regulatory standards and developing pivotal documents for clinical studies. Ideal candidates will have a Bachelor's degree, strong writing skills, and familiarity with FDA regulations.

Benefits

Company car or allowance

Health coverage

401k matching

Stock purchase plans

Performance bonuses

Flexible PTO

Qualifications

• Bachelor's degree required with relevant experience.
• Understanding of FDA and ICH regulations preferred.
• Ability to interpret and present clinical data.

Responsibilities

• Mentor and lead less experienced medical writers.
• Develop or support clinical study documents.
• Manage medical writing activities across departments.

Skills

Excellent command of English grammar

Effective presentation skills

Proofreading

Interpersonal skills

Team orientation

Education

Bachelor's degree in Science or Arts

Tools

Word

Excel

PowerPoint

Job description

Principal Medical Writer (Regulatory)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

Our Clinical Development model centers on the customer and patient, continually seeking ways to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether partnering in a Functional Service Provider or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our clients achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

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

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We invest in our people through career development, supportive management, training, peer recognition, and rewards.
• We promote a Total Self culture, encouraging authenticity and well-being.
• We value diversity of thought, background, and culture to foster a sense of belonging.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Represent the Medical Writing department in clinical study teams, conferences, and client presentations.
• Advise clients and study teams on data presentation, production strategies, and quality standards.
• Develop strong working relationships internally and externally.
• Manage medical writing activities for individual studies, coordinating across departments.
• Develop or support documents such as clinical study protocols, reports, patient narratives, development plans, submissions, and manuscripts.
• Review statistical analysis plans and specifications for content and formatting.
• Serve as peer reviewer to ensure clarity, accuracy, and quality.
• Adhere to regulatory standards, SOPs, templates, and deadlines.
• Perform literature searches and maintain professional development.
• Understand budget constraints and communicate effectively with leadership.
• Complete administrative tasks timely; minimal travel may be required.

Qualifications

• Bachelor's degree in Science or Arts with relevant experience and scientific/medical knowledge.
• Excellent command of English grammar, familiarity with AMA style.
• Understanding of FDA and ICH regulations preferred.
• Effective presentation, proofreading, interpersonal skills, and team orientation.
• Proficiency in Word, Excel, PowerPoint, email, and internet.
• Ability to interpret and present clinical data and complex information.

We offer benefits such as a company car or allowance, health coverage, 401k matching, stock purchase plans, performance bonuses, flexible PTO, and compliance with local sick time laws. Salary range: $95,000 - $175,700, depending on qualifications and experience.

Get to know Syneos Health

Over the past 5 years, we collaborated on 94% of FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies involving thousands of sites and patients.

Join us in challenging the status quo and making a difference. Learn more at http://www.syneoshealth.com.

Additional Information

Tasks and responsibilities are not exhaustive. The company may assign additional duties at its discretion. Qualifications are considered in context of equivalent experience or education. This statement does not constitute a contract. We are committed to compliance with applicable laws and providing reasonable accommodations under the ADA.