Syneos Health is hiring a Principal Medical Writer - Single Sponsor Dedicated - Submission Documents

Syneos Health is hiring a Principal Medical Writer for a dedicated single-sponsor role focused on submission documents. You will represent the Medical Writing department on clinical study teams, advising clients on data presentation strategies and developing a wide range of regulatory and clinical documents.

What You'll Do

• Mentor and lead less experienced medical writers on complex projects.
• Represent the Medical Writing department on clinical study teams, at conferences, and in client presentations.
• Advise clients and study teams on data presentation and production strategies.
• Develop good working relationships with internal and external colleagues.
• Manage medical writing activities for individual studies with minimal supervision.
• Develop or support documents including clinical study protocols, reports, patient narratives, development plans, IND/NDA submissions, investigator brochures, and manuscripts.
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
• Serve as a peer reviewer to ensure clarity, accuracy, and adherence to client objectives and quality standards.
• Adhere to established regulatory standards (e.g., ICH-E3), company SOPs, and client templates.
• Perform on-line clinical literature searches.
• Continue professional development to keep pace with regulatory guidance and client expectations.
• Understand and work within budget specifications for assigned projects.
• Complete required administrative tasks within specified timeframes.

What We're Looking For

• A Bachelor of Science degree with relevant writing experience OR a Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge.
• Extensive knowledge of English grammar and familiarity with the AMA style guide.
• Demonstrated effective presentation, proofreading, and interpersonal skills.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data.

Nice to Have

• Understanding of FDA and ICH regulations and guidelines.

Technical Stack

• Word
• Excel
• PowerPoint

Team & Environment

You will represent the Medical Writing department on clinical study teams.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate.