Senior Medical Writer – Early Phase (Remote)

Syneos Health, Inc.; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

Syneos Health, Inc. is seeking a Senior Medical Writer for Early Phase (Single Sponsor Support). This remote role spans multiple regulatory documents and collaborations across departments to deliver compliant submissions.

The candidate should have strong EMA/FDA/ICH knowledge, years of regulatory writing experience, and familiarity with AMA style. Travel is limited; collaboration is global and project-driven.

Qualifications

• Strong understanding of EMA, FDA and ICH regulations.
• Experience writing regulatory documents across study types.
• Ability to ensure clarity, accuracy and regulatory compliance in submissions.
• Familiarity with AMA Manual of Style for medical writing.
• Experience in early-phase or single sponsor settings preferred.

Responsibilities

• Lead medical writing deliverables with minimal supervision.
• Coordinate cross-department writing activities and client reviews.
• Ensure regulatory standards and templates are followed.
• Mentor junior writers on complex projects.
• Review statistical output and prepare accompanying documents.

Skills

Regulatory writing

Biopharmaceutical industry

English grammar

AMA Style

Job description

Syneos Health, Inc. is seeking a Senior Medical Writer for Early Phase (Single Sponsor Support). This remote role spans multiple regulatory documents and collaborations across departments to deliver compliant submissions.

The candidate should have strong EMA/FDA/ICH knowledge, years of regulatory writing experience, and familiarity with AMA style. Travel is limited; collaboration is global and project-driven.