Senior Medical Writer, Publications Lead

1001 Syneos Health, LLC; Town of Vermont (WI); Hybrid; USD 81,000 - 176,000; Full time

Benefits offered by this job

Health benefits

401k match

Stock purchase plan

Bonus potential

Paid time off

Job summary

Syneos Health is seeking a Principal Medical Writer - Publications in the United States. You will lead the preparation of complex medical writing deliverables, ensuring accuracy and clarity across protocols, CSR, IBs, and submissions.

You will coordinate with data management, biostatistics, regulatory affairs, and medical affairs to meet client objectives and maintain quality standards. You will mentor junior writers, review documents for accuracy, and contribute to internal process improvements

Qualifications

• Experience leading medical writing deliverables for complex studies.
• Strong knowledge of ICH E3 guidelines and SOPs.
• Ability to coordinate across departments to meet client objectives.

Responsibilities

• Leads the completion of complex medical writing deliverables with minimal supervision.
• Manages documents for studies, defining strategy and coordinating activities across departments.
• Adheres to regulatory standards and client templates during writing projects.
• Mentors less experienced medical writers and provides expert reviews.
• Represents the medical writing team in study teams and client meetings.

Skills

Medical writing

Regulatory standards

Team leadership

Client liaison

Job description

Syneos Health is seeking a Principal Medical Writer - Publications in the United States. You will lead the preparation of complex medical writing deliverables, ensuring accuracy and clarity across protocols, CSR, IBs, and submissions.

You will coordinate with data management, biostatistics, regulatory affairs, and medical affairs to meet client objectives and maintain quality standards. You will mentor junior writers, review documents for accuracy, and contribute to internal process improvements