Senior Medical Writer, Clinical Solutions Leader

Syneos Health, Inc.; United States; Remote; USD 81,000 - 176,000; Full time

Benefits offered by this job

Health benefits

401k match

Employee Stock Purchase Plan

Commissions/Bonus

Flexible PTO

Car allowance

Job summary

Syneos Health, Inc. seeks an experienced Medical Writer to lead the preparation of regulatory and scientific documents for multiple studies, ensuring accuracy and compliance with ICH E3 guidelines and company standards.

You will coordinate with data management, biostatistics, regulatory affairs, and medical affairs to deliver high-quality writing deliverables on time and within budget, while mentoring junior writers and supporting business development through effective client interaction.

Qualifications

• Medical writing experience preferred.
• Familiarity with regulatory standards (ICH E3, templates, guidelines).
• Ability to coordinate with cross-functional teams and clients.

Responsibilities

• Leads the completion of medical writing deliverables with clarity and accuracy across studies.
• Prepares documents such as protocols, clinical study reports, summaries, and submissions.
• Ensures compliance with regulatory standards and internal SOPs, budgets, and timelines.
• Coordinates reviews, mentors junior writers, and communicates with clients and cross-functional teams.

Job description

Syneos Health, Inc. seeks an experienced Medical Writer to lead the preparation of regulatory and scientific documents for multiple studies, ensuring accuracy and compliance with ICH E3 guidelines and company standards.

You will coordinate with data management, biostatistics, regulatory affairs, and medical affairs to deliver high-quality writing deliverables on time and within budget, while mentoring junior writers and supporting business development through effective client interaction.