Principal/Sr Medical Writer (Regulatory)

Syneos Health, Inc.; United States; On-site; USD 60,000 - 116,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Principal/Sr Medical Writer to lead complex writing projects and mentor junior writers. The role involves developing regulatory documents and collaborating across departments to ensure compliance and quality. Join a diverse team dedicated to improving patient outcomes through innovative therapy delivery.

Benefits

Company car or allowance

Health benefits

401k match

Stock purchase plan

Bonuses

Flexible PTO

Sick leave

Qualifications

• Extensive knowledge of English grammar, FDA, ICH regulations.
• Ability to interpret clinical data.

Responsibilities

• Mentor and lead less experienced medical writers.
• Develop clinical study protocols, reports, and regulatory submissions.
• Collaborate with data management and medical affairs teams.

Skills

Leadership

Presentation

Proofreading

Interpersonal

Education

Bachelor's degree in Science or Arts

Tools

Word

Excel

PowerPoint

Job description

Principal/Sr Medical Writer (Regulatory)

Updated: May 17, 2025
Location: United States

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.

Our Clinical Development model centers on the customer and the patient. We continuously seek to simplify and streamline our work to make Syneos Health both 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 to help our customers 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 develop our people through career progression, supportive management, training, peer recognition, and rewards.
• We foster a Total Self culture, where you can be authentic. We are committed to caring for our people.
• We value diversity of thought, background, and perspective to create an inclusive environment.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Act as lead for assigned writing projects.
• Manage medical writing activities related to studies, coordinating within and across departments with minimal supervision.
• Develop or support various documents including clinical study protocols, reports, development plans, regulatory submissions, manuscripts, and presentations.
• Identify and resolve issues during the writing process, escalating as needed.
• Review statistical analysis plans and specifications for content, grammar, and format.
• Collaborate with data management, biostatistics, regulatory, and medical affairs teams.
• Serve as peer reviewer on internal reviews.
• Adhere to regulatory standards, SOPs, templates, and client standards, ensuring timely and budget-compliant delivery.
• Perform literature searches and stay updated on industry practices and regulations.
• Monitor budget and communicate changes.
• Complete administrative tasks timely; minimal travel may be required.

Qualifications

What we’re looking for

• Bachelor's degree in Science or Arts with relevant experience and knowledge of medical/scientific principles.
• Extensive knowledge of English grammar, FDA, ICH regulations, and familiarity with AMA style.
• Independent with strong presentation, proofreading, interpersonal, and leadership skills.
• Proficiency in Word, Excel, PowerPoint, email, and internet.
• Understanding of clinical research principles and ability to interpret clinical data.

Additional Information

Our benefits may include a company car or allowance, health benefits, 401k match, stock purchase plan, bonuses, flexible PTO, and sick leave, depending on location and regulations.

The salary range for this position is $60,930 to $115,100 annually, based on qualifications and experience.

Tasks and responsibilities are not exhaustive; additional duties may be assigned. We are committed to compliance with applicable laws and providing reasonable accommodations under the ADA.

Join us to make a difference—your work helps bring therapies to patients worldwide. We support a diverse, equitable, and inclusive culture.